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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02075840
Registration number
NCT02075840
Ethics application status
Date submitted
27/02/2014
Date registered
3/03/2014
Date last updated
12/08/2024
Titles & IDs
Public title
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
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Scientific title
Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
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Secondary ID [1]
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2013-004133-33
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Secondary ID [2]
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BO28984
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Universal Trial Number (UTN)
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Trial acronym
ALEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Alectinib
Treatment: Drugs - Crizotinib
Experimental: Alectinib - Participants will receive alectinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Active comparator: Crizotinib - Participants will receive crizotinib from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment: Drugs: Alectinib
Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
Treatment: Drugs: Crizotinib
Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
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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) by Investigator Assessment
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Assessment method [1]
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PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
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Timepoint [1]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Primary outcome [2]
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Percentage of Participants With PFS Event by Investigator Assessment
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Assessment method [2]
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PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.
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Timepoint [2]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [1]
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PFS Independent Review Committee (IRC)-Assessed
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Assessment method [1]
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PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
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Timepoint [1]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [2]
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Percentage of Participants With PFS Event by IRC
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Assessment method [2]
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PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.
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Timepoint [2]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [3]
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Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria
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Assessment method [3]
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CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
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Timepoint [3]
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Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)
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Secondary outcome [4]
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Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria
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Assessment method [4]
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CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.
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Timepoint [4]
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Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)
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Secondary outcome [5]
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Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria
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Assessment method [5]
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ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
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Timepoint [5]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [6]
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Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators
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Assessment method [6]
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DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
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Timepoint [6]
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First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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Overall survival (OS) was defined as the time from randomization to death from any cause.
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Timepoint [7]
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From randomization until death (up to 43 months)
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Secondary outcome [8]
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Percentage of Participants With OS Event
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Assessment method [8]
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Overall survival (OS) was defined as the time from randomization to death from any cause.
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Timepoint [8]
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From randomization until death (up to 43 months)
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Secondary outcome [9]
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Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria
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Assessment method [9]
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CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
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Timepoint [9]
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Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [10]
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CNS DOR IRC-assessed According to RECIST v1.1 Criteria
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Assessment method [10]
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CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.
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Timepoint [10]
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First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)
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Secondary outcome [11]
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Percentage of Participants With Adverse Events
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Assessment method [11]
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An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Timepoint [11]
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Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm
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Secondary outcome [12]
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Area Under The Concentration-Time Curve (AUC) of Alectinib
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Assessment method [12]
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Timepoint [12]
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Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
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Secondary outcome [13]
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Maximum Concentration (Cmax) of Alectinib
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Assessment method [13]
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Timepoint [13]
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Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
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Secondary outcome [14]
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Time to Reach Cmax (Tmax) of Alectinib
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Assessment method [14]
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Timepoint [14]
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Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
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Secondary outcome [15]
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AUC of Alectinib Metabolite
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Assessment method [15]
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Timepoint [15]
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Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
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Secondary outcome [16]
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Cmax of Alectinib Metabolite
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Assessment method [16]
0
0
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Timepoint [16]
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Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
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Secondary outcome [17]
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Tmax of Alectinib Metabolite
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Assessment method [17]
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0
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Timepoint [17]
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Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)
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Secondary outcome [18]
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Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)
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Assessment method [18]
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The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
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Timepoint [18]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [19]
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Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)
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Assessment method [19]
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The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a \>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.
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Timepoint [19]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [20]
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Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
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Assessment method [20]
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The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
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Timepoint [20]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [21]
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Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
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Assessment method [21]
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The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
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Timepoint [21]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [22]
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Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score
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Assessment method [22]
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The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
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Timepoint [22]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [23]
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HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing
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Assessment method [23]
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The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
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Timepoint [23]
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Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [24]
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HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea
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Assessment method [24]
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The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
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Timepoint [24]
0
0
Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [25]
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HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest
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Assessment method [25]
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0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
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Timepoint [25]
0
0
Baseline, every 4 weeks until disease progression (up to 33 months)
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Secondary outcome [26]
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HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder
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Assessment method [26]
0
0
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.
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Timepoint [26]
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0
Baseline, every 4 weeks until disease progression (up to 33 months)
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test
* Life expectancy of at least 12 weeks
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* Participants with no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
* Adequate renal, and hematologic function
* Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
* Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1) prior to the administration of study treatment
* Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline)
* Negative pregnancy test for all females of child bearing potential
* Use of highly effective contraception as defined by the study protocol
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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
* Participants with a previous malignancy within the past 3 years
* Any gastrointestinal (GI) disorder or liver disease
* National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
* History of organ transplant
* Co-administration of anti-cancer therapies other than those administered in this study
* Participants with baseline QTc greater than (>) 470 milliseconds or symptomatic bradycardia
* Recipient of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose until the end of study treatment
* Recipient of any drug with potential QT interval prolonging effects within 14 days prior to the first dose for all participants and while on treatment through the end of the study for crizotinib-treated participants only
* History of hypersensitivity to any of the additives in the alectinib and crizotinib drug formulation
* Pregnancy or lactation
* Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
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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
Active, not recruiting
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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
19/08/2014
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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
29/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
303
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
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Recruitment hospital [2]
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0
Royal North Shore Hospital; Oncology - St. Leonards
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Recruitment hospital [3]
0
0
Calvary Mater Newcastle; Medical Oncology - Waratah
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Recruitment hospital [4]
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0
Queen Elizabeth Hospital; Medical Oncology - Woodville South
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Recruitment hospital [5]
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0
Monash Health Translational Precinct; Clinical Trials Centre, Level 3 - Victoria
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Recruitment postcode(s) [1]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [2]
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0
2065 - St. Leonards
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Recruitment postcode(s) [3]
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0
2298 - Waratah
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Recruitment postcode(s) [4]
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0
5011 - Woodville South
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Recruitment postcode(s) [5]
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3168 - Victoria
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Massachusetts
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Missouri
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Nevada
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
Bosnia and Herzegovina
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State/province [14]
0
0
Banja Luka
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Country [15]
0
0
Bosnia and Herzegovina
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State/province [15]
0
0
Sarajevo
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Country [16]
0
0
Brazil
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State/province [16]
0
0
RS
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Country [17]
0
0
Brazil
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State/province [17]
0
0
SP
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Country [18]
0
0
Canada
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State/province [18]
0
0
Alberta
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Country [19]
0
0
Canada
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State/province [19]
0
0
Ontario
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Country [20]
0
0
Canada
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State/province [20]
0
0
Saskatchewan
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Country [21]
0
0
Chile
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State/province [21]
0
0
Recoleta
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Country [22]
0
0
China
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State/province [22]
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Funding & Sponsors
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Name
Hoffmann-La Roche
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Summary
Brief summary
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
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Trial website
https://clinicaltrials.gov/study/NCT02075840
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Trial related presentations / publications
Dziadziuszko R, Peters S, Mok T, Camidge DR, Gadgeel SM, Ou SI, Konopa K, Noe J, Nowicka M, Bordogna W, Morcos PN, Smoljanovic V, Shaw AT. Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. Clin Cancer Res. 2022 May 2;28(9):1800-1808. doi: 10.1158/1078-0432.CCR-21-2840. Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, Perol M, Ou SI, Ahn JS, Shaw AT, Bordogna W, Smoljanovic V, Hilton M, Ruf T, Noe J, Peters S. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020 Aug;31(8):1056-1064. doi: 10.1016/j.annonc.2020.04.478. Epub 2020 May 11. Gadgeel S, Peters S, Mok T, Shaw AT, Kim DW, Ou SI, Perol M, Wrona A, Novello S, Rosell R, Zeaiter A, Liu T, Nuesch E, Balas B, Camidge DR. Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study. Ann Oncol. 2018 Nov 1;29(11):2214-2222. doi: 10.1093/annonc/mdy405. Burudpakdee C, Wong W, Seetasith A, Corvino FA, Yeh W, Gubens M. Economic impact of preventing brain metastases with alectinib in ALK-positive non-small cell lung cancer. Lung Cancer. 2018 May;119:103-111. doi: 10.1016/j.lungcan.2018.03.008. Epub 2018 Mar 9. Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6. Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.
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Contacts
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Hoffmann-La Roche
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/40/NCT02075840/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/40/NCT02075840/SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02075840
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