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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/NCT00102804
Registration number
NCT00102804
Ethics application status
Date submitted
1/02/2005
Date registered
2/02/2005
Date last updated
29/12/2014
Titles & IDs
Public title
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer
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Secondary ID [1]
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H3E-MC-JMEN
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Secondary ID [2]
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5122
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Lung - Non small cell
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Cancer
0
0
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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 - Pemetrexed
Treatment: Drugs - Placebo
Other interventions - Best Supportive Care
Experimental: Pemetrexed and Best Supportive Care -
Placebo Comparator: Placebo and Best Supportive Care -
Treatment: Drugs: Pemetrexed
500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression
Treatment: Drugs: Placebo
IV administration, q 21 days
Other interventions: Best Supportive Care
Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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) Time
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Assessment method [1]
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PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
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Timepoint [1]
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Randomization to measured PD or death from any cause (up to 41 months)
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Secondary outcome [1]
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Overall Survival (OS) Time
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Assessment method [1]
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OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.
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Timepoint [1]
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Randomization to date of death from any cause (up to 41 months)
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Secondary outcome [2]
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Time to Objective Progressive Disease (TPD)
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Assessment method [2]
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TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant's last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
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Timepoint [2]
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Randomization to measured PD (up to 41 months)
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Secondary outcome [3]
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Time to Worsening of Symptoms (TWS)
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Assessment method [3]
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TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
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Timepoint [3]
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Randomization to worsening of each LCSS item (up to 39 months)
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Secondary outcome [4]
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Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)
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Assessment method [4]
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Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.
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Timepoint [4]
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Baseline to measured PD (up to 41 months)
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Secondary outcome [5]
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Number of Participants With Adverse Events (AEs)
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Assessment method [5]
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Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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Timepoint [5]
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Baseline to study completion (up to 41 Months)
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Secondary outcome [6]
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Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
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Assessment method [6]
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The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
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Timepoint [6]
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Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
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Eligibility
Key inclusion criteria
- Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or
positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.
- Participants must have had 1 of the following induction therapies for treatment for
Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV
NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus
carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus
cisplatin.
- Participants must have received only 1 chemotherapeutic doublet lasting precisely 4
cycles.
- Induction regimens must be based on 21-day cycles.
- Documented evidence of a tumor response of complete response (CR), partial response
(PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of
induction therapy and the date of randomization. This response does not have to be
confirmed in order for the participant to be randomized. Positron emission tomography
(PET) scans and ultrasounds may not be used for lesion measurements for response
determination.
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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
- With the exception of those chemotherapies listed as inclusion criterion, participants
will not be included if they have received prior systemic anticancer therapy
(including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any
other cancer.
- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that would compromise the participant's
ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or
heart disease, as defined by the New York Heart Association Class III or IV.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
1/03/2005
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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
1/12/2013
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Sample size
Target
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Accrual to date
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Final
663
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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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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bankstown
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Coffs Harbour
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kogarah
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Recruitment hospital [4]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Port Macquarie
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Recruitment hospital [5]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nambour
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Recruitment hospital [6]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Townsville
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Recruitment hospital [7]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ashford
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Recruitment hospital [8]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2450 - Coffs Harbour
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2444 - Port Macquarie
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Recruitment postcode(s) [5]
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4560 - Nambour
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Recruitment postcode(s) [6]
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4810 - Townsville
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Recruitment postcode(s) [7]
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5035 - Ashford
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Recruitment postcode(s) [8]
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VIC 3199 - Frankston
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Recruitment outside Australia
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United States of America
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Minnesota
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United States of America
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New Hampshire
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Pennsylvania
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United States of America
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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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Wisconsin
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Austria
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Vienna
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Brazil
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Ijui
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Varna
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China
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Beijing
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China
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Dalian
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China
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Guang Zhou
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China
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Hangzhou
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China
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Ji Nan
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China
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Nan Jing
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China
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Zagreb
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Brno
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Ostrava-Poruba
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Prague
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Hamburg
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Germany
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Hamm
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Germany
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Hannover
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Germany
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Germany
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Ulm
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Athens
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Chania
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Hungary
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Mosdos
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Hungary
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Szombathely
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Banglagore
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Jaipur
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India
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Mumbai
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India
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P.O Ernakulam
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India
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Trivandrum
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Italy
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Bari
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Italy
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Bologna
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Italy
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Genova
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Italy
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Livorno
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Italy
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Messina
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Italy
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Padova
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Italy
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Pisa
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Italy
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Rome
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Italy
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Rozzano
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Ede
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Zutphen
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Alcorcon
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Barcelona
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Granada
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Mataró
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Murcia
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Palma De Mallorca
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Spain
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Santa Cruz De Tenerife
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Taiwan
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Taipei
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Turkey
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Ankara
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best
supportive care versus placebo plus best supportive care in NSCLC. Participants must have
received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to
randomization (enrollment) into this trial.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00102804
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00102804
Download to PDF