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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01154140
Registration number
NCT01154140
Ethics application status
Date submitted
29/06/2010
Date registered
30/06/2010
Date last updated
6/11/2017
Titles & IDs
Public title
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
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Scientific title
Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.
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Secondary ID [1]
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2010-021336-33
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Secondary ID [2]
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A8081014
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Universal Trial Number (UTN)
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Trial acronym
PROFILE 1014
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Squamous Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - treatment
Treatment: Drugs - treatment
Experimental: A -
Active Comparator: B -
Treatment: Drugs: treatment
crizotinib 250mg orally continuous twice daily dosing
Treatment: Drugs: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) Based on IRR
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Assessment method [1]
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PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
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Timepoint [1]
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Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.
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Timepoint [1]
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From randomization to death or last date known alive for those not known to have died (up to 72 months)
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Secondary outcome [2]
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Overall Survival Probability at Month 12 and 18
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Assessment method [2]
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Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.
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Timepoint [2]
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Month 12, 18
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Secondary outcome [3]
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Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
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Assessment method [3]
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ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.
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Timepoint [3]
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Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [4]
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Duration of Response (DR) Based on IRR
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Assessment method [4]
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DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
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Timepoint [4]
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From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [5]
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Time to Tumor Response (TTR) Based on IRR
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Assessment method [5]
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TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
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Timepoint [5]
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Randomization to first documentation of objective tumor response (up to 35 months)
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Secondary outcome [6]
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Percentage of Participants With Disease Control at Week 12 Based on IRR
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Assessment method [6]
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Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Time to Progression (TTP) Based on IRR
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Assessment method [7]
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TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44.
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Timepoint [7]
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Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [8]
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Time to Intracranial Progression (IC-TTP) Based on IRR
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Assessment method [8]
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IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
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Timepoint [8]
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Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [9]
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Time to Extracranial Progression (EC-TTP) Based on IRR
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Assessment method [9]
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EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
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Timepoint [9]
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Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [10]
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Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [10]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
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Timepoint [10]
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Baseline up to follow up period (up to 72 months)
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Secondary outcome [11]
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Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [11]
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Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
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Timepoint [11]
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Baseline up to follow up period (up to 72 months)
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Secondary outcome [12]
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Percentage of Participants With Adverse Events (AEs) According to Maximum Severity
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Assessment method [12]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
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Timepoint [12]
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Baseline up to follow up period (up to 72 months)
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Secondary outcome [13]
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Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182
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Assessment method [13]
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Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.
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Timepoint [13]
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Predose at Day 1 of Cycle 2, 3 and 5
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Secondary outcome [14]
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Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
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Assessment method [14]
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The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.
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Timepoint [14]
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28 days prior to day 1 of study treatment
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Secondary outcome [15]
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Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR
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Assessment method [15]
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The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
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Timepoint [15]
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Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
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Secondary outcome [16]
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Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough
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Assessment method [16]
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TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.
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Timepoint [16]
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From randomization of treatment up to deterioration while on study treatment (up to 35 months)
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Secondary outcome [17]
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Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
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Assessment method [17]
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EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
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Timepoint [17]
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Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
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Secondary outcome [18]
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Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
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Assessment method [18]
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EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
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Timepoint [18]
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Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
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Secondary outcome [19]
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Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)
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Assessment method [19]
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QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.
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Timepoint [19]
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Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
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Secondary outcome [20]
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Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)
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Assessment method [20]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.
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Timepoint [20]
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Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
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Secondary outcome [21]
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Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)
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Assessment method [21]
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Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.
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Timepoint [21]
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Baseline up to follow up period (up to 72 months)
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Secondary outcome [22]
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Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities
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Assessment method [22]
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Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.
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Timepoint [22]
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Baseline up to follow up period (up to 72 months)
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Secondary outcome [23]
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Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities
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Assessment method [23]
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ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.
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Timepoint [23]
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Baseline up to follow up period (up to 72 months)
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Eligibility
Key inclusion criteria
- Proven diagnosis of locally advanced not suitable for local treatment, recurrent and
metastatic non-squamous cell carcinoma of the lung
- Positive for translocation or inversion events involving the ALK gene locus
- No prior systemic treatment for locally advanced or metastatic disease; Patients with
brain metastases only if treated and neurologically stable with no ongoing requirement
for corticosteroids
- Evidence of a personally signed and dated informed consent document and willingness
and ability to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures including completion of patient reported outcome [PRO]
measures.
- 18 years of age or older with the exception of India which has an upper age limit of
65 years old
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
congestive heart failure, or cerebrovascular accident including transient ischemic
attack. - - Appropriate treatment with anticoagulants is permitted.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation
of any grade, or QTc interval >470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use
of drugs that are CYP3A4 substrates with narrow therapeutic indices.
- Known HIV infection
- Known interstitial lung disease or interstitial fibrosis
- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory
abnormalities that would impart, in the judgment of the investigator and/or sponsor,
excess risk associated with study participation or study drug administration, and
which would, therefore, make the patient inappropriate for entry into this study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/11/2016
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Sample size
Target
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Accrual to date
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Final
343
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Macarthur Cancer Therapy Centre - Campbelltown
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Recruitment hospital [2]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [3]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [4]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [5]
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The Townsville Hospital - Douglas
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Recruitment hospital [6]
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The Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [7]
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Parkhaven Medical Center - Hyde Park
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Recruitment hospital [8]
0
0
Department of Medical Oncology - Adelaide
Query!
Recruitment hospital [9]
0
0
Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology - East Melbourne
Query!
Recruitment hospital [10]
0
0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Query!
Recruitment postcode(s) [1]
0
0
2560 - Campbelltown
Query!
Recruitment postcode(s) [2]
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0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
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0
2065 - St. Leonards
Query!
Recruitment postcode(s) [4]
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0
4032 - Chermside
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Recruitment postcode(s) [5]
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0
4814 - Douglas
Query!
Recruitment postcode(s) [6]
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0
4006 - Herston
Query!
Recruitment postcode(s) [7]
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0
4812 - Hyde Park
Query!
Recruitment postcode(s) [8]
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0
5000 - Adelaide
Query!
Recruitment postcode(s) [9]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [10]
0
0
3199 - Frankston
Query!
Recruitment outside Australia
Country [1]
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0
United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Michigan
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United States of America
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Missouri
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New Hampshire
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United States of America
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New Jersey
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New Mexico
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United States of America
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New York
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Austria
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Wels
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Belgium
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Antwerp
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Belgium
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Hainaut
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Liege
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Belgium
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Roeselare
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
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Country [34]
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Cautin
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Chile
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RM
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Chile
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State/province [41]
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Santiago, Rm
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Country [42]
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China
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State/province [42]
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Beijing
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Country [43]
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China
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Guangdong
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China
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Hubei
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China
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Jiangsu
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China
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Sichuan
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Country [47]
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China
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State/province [47]
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Shanghai
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Country [48]
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0
Finland
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State/province [48]
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Helsinki
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Country [49]
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Finland
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State/province [49]
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Pori
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Country [50]
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Finland
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State/province [50]
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Tampere
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Country [51]
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0
France
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State/province [51]
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Bobigny Cedex
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Country [52]
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France
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Caen Cedex
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France
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State/province [53]
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Grenoble Cedex
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0
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France
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State/province [54]
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Lille
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Country [55]
0
0
France
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State/province [55]
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Lyon Cedex 08
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Country [56]
0
0
France
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State/province [56]
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Marseille Cedex 20
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Country [57]
0
0
France
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State/province [57]
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0
Montpellier
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Country [58]
0
0
France
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State/province [58]
0
0
Paris cedex 20
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Country [59]
0
0
France
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State/province [59]
0
0
Strasbourg
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Country [60]
0
0
Germany
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State/province [60]
0
0
Bad Berka
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Country [61]
0
0
Germany
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State/province [61]
0
0
Berlin
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Country [62]
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0
Germany
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Heidelberg
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Country [63]
0
0
Germany
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Karlsruhe
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Country [64]
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0
Germany
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0
Mainz
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Country [65]
0
0
Germany
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State/province [65]
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0
Moenchengladbach
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Country [66]
0
0
Germany
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State/province [66]
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Oldenburg
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Country [67]
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0
Germany
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State/province [67]
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Wiesbaden
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Country [68]
0
0
Hong Kong
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State/province [68]
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New Territories
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Country [69]
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0
Hong Kong
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State/province [69]
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Kowloon
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Country [70]
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India
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Gujarat
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Country [71]
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India
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State/province [71]
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Maharashtra
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Country [72]
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Ireland
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State/province [72]
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Dublin
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Country [73]
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Italy
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State/province [73]
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Pordenone
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Country [74]
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Italy
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State/province [74]
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Aviano (PN)
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Country [75]
0
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Italy
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Bari
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Country [76]
0
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Italy
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State/province [76]
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Bologna
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Country [77]
0
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Italy
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State/province [77]
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Catanzaro
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Country [78]
0
0
Italy
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State/province [78]
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0
Livorno
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Country [79]
0
0
Italy
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State/province [79]
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Milano
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Country [80]
0
0
Italy
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State/province [80]
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Napoli
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Country [81]
0
0
Italy
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State/province [81]
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0
Orbassano (TO)
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Country [82]
0
0
Italy
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State/province [82]
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Parma
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Country [83]
0
0
Italy
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State/province [83]
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Perugia
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Country [84]
0
0
Italy
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State/province [84]
0
0
Reggio Emilia
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Country [85]
0
0
Italy
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State/province [85]
0
0
Roma
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Country [86]
0
0
Japan
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State/province [86]
0
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Aichi
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Country [87]
0
0
Japan
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State/province [87]
0
0
Chiba
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Country [88]
0
0
Japan
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State/province [88]
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Ehime
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Country [89]
0
0
Japan
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State/province [89]
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0
Hokkaido
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Country [90]
0
0
Japan
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State/province [90]
0
0
Hyogo
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Country [91]
0
0
Japan
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State/province [91]
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0
Kanagawa
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Country [92]
0
0
Japan
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State/province [92]
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0
Miyagi
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Country [93]
0
0
Japan
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State/province [93]
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0
Okayama
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Country [94]
0
0
Japan
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State/province [94]
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Osaka
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Country [95]
0
0
Japan
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State/province [95]
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0
Shizuoka
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Country [96]
0
0
Japan
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State/province [96]
0
0
Tokyo
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Country [97]
0
0
Japan
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State/province [97]
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0
Yamaguchi
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Country [98]
0
0
Japan
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State/province [98]
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0
Fukuoka
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Country [99]
0
0
Korea, Republic of
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State/province [99]
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Seoul
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Country [100]
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0
Luxembourg
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State/province [100]
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Luxembourg
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Country [101]
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0
Mexico
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State/province [101]
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D.f.
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Country [102]
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0
Netherlands
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State/province [102]
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0
NB
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Country [103]
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0
Netherlands
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State/province [103]
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Amsterdam
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Country [104]
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0
Netherlands
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State/province [104]
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Maastricht
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Country [105]
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0
Norway
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State/province [105]
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Oslo
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Country [106]
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0
Peru
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State/province [106]
0
0
Lima
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Country [107]
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Portugal
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State/province [107]
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Coimbra
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Country [108]
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Portugal
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State/province [108]
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0
Lisboa
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Country [109]
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0
Portugal
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State/province [109]
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0
Vila Nova de Gaia
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Country [110]
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0
Russian Federation
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State/province [110]
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Moscow
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Country [111]
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Russian Federation
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State/province [111]
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Saint-Petersburg
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Country [112]
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Russian Federation
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State/province [112]
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Samara
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Country [113]
0
0
Singapore
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State/province [113]
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Singapore
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Country [114]
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0
South Africa
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State/province [114]
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Gauteng
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Country [115]
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0
South Africa
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State/province [115]
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Cape Town
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Country [116]
0
0
Spain
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State/province [116]
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0
Alicante
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Country [117]
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0
Spain
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State/province [117]
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0
Andalucia
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Country [118]
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0
Spain
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State/province [118]
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Aragon
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Country [119]
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Spain
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State/province [119]
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Catalunya
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Country [120]
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Spain
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State/province [120]
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Barcelona
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Country [121]
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0
Spain
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State/province [121]
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0
Las Palmas de Gran Canaria
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Country [122]
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0
Spain
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State/province [122]
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0
Madrid
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Country [123]
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0
Spain
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Malaga
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Country [124]
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0
Switzerland
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State/province [124]
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Basel
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Country [125]
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Switzerland
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State/province [125]
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Luzern
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Country [126]
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0
Switzerland
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State/province [126]
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0
Winterthur
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Country [127]
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0
Taiwan
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State/province [127]
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0
Kaohsiung City
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Country [128]
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0
Taiwan
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State/province [128]
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Taichung
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Country [129]
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0
Taiwan
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State/province [129]
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Taoyuan
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Country [130]
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0
Ukraine
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State/province [130]
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0
Dnipropetrovsk
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Country [131]
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Ukraine
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State/province [131]
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Kyiv
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Country [132]
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0
Ukraine
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State/province [132]
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Lviv
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Country [133]
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0
United Kingdom
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State/province [133]
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0
Cambridgeshire
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Country [134]
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United Kingdom
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Hertfordshire
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Country [135]
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United Kingdom
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Lancashire
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Country [136]
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United Kingdom
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Middlesex
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Country [137]
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United Kingdom
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Scotland
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Country [138]
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0
United Kingdom
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State/province [138]
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0
Aberdeen
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Country [139]
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0
United Kingdom
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State/province [139]
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0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the anti-cancer effects of crizotinib when compared with standard
chemotherapy in patients with ALK positive lung cancer.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01154140
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
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0
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Country
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0
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Phone
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0
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Fax
0
0
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Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01154140
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