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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/NCT00940875
Registration number
NCT00940875
Ethics application status
Date submitted
6/07/2009
Date registered
16/07/2009
Date last updated
2/04/2015
Titles & IDs
Public title
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
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Scientific title
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.
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Secondary ID [1]
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ML22429
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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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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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 - erlotinib [Tarceva]
Treatment: Drugs - gemcitabine
Treatment: Drugs - gemcitabine
Experimental: 1 -
Active Comparator: 2 -
Treatment: Drugs: erlotinib [Tarceva]
150mg po on days 15-28 of each 4 week cycle
Treatment: Drugs: gemcitabine
1250mg/m2/day on days 1 and 8 of each 4 week cycle
Treatment: Drugs: gemcitabine
1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
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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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Percentage of Participants With Disease Progression or Death
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Assessment method [1]
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Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.
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Timepoint [1]
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BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
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Primary outcome [2]
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PFS
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Assessment method [2]
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The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.
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Timepoint [2]
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BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)
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Secondary outcome [1]
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Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
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Assessment method [1]
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As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.
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Timepoint [1]
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BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).
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Secondary outcome [2]
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Percentage of Participants With Non-Progression at Weeks 8 and 16
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Assessment method [2]
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Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.
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Timepoint [2]
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Weeks 8 and 16
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Secondary outcome [3]
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Percentage of Participants Who Died
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Assessment method [3]
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Timepoint [3]
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BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.
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Timepoint [4]
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BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
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Secondary outcome [5]
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Duration of Response
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Assessment method [5]
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Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.
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Timepoint [5]
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BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.
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Eligibility
Key inclusion criteria
- adult patients, >=70 years of age or with ECOG PS of 2;
- advanced (stage IIIB or IV)non-small cell lung cancer;
- no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis
targeted drugs.
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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
- active brain metastasis or spinal cord suppression;
- unstable systemic disease.
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
1/06/2009
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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
1/09/2011
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Sample size
Target
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Accrual to date
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Final
54
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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- Port Macquarie
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Recruitment hospital [2]
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- Randwick
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Recruitment hospital [3]
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- Sydney
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Recruitment hospital [4]
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- Tweed Heads
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Recruitment hospital [5]
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- Wollongong
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Recruitment hospital [6]
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- Brisbane
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Recruitment hospital [7]
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- Greenslopes
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Recruitment hospital [8]
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- Woolloongabba
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Recruitment hospital [9]
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- Richmond
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Recruitment hospital [10]
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- Terrace Gardens
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Recruitment hospital [11]
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- Hobart
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Recruitment hospital [12]
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- Bendigo
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Recruitment hospital [13]
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- Heidelberg
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Recruitment hospital [14]
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- Melbourne
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Recruitment hospital [15]
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- Wodonga
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Recruitment hospital [16]
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- Fremantle
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Recruitment postcode(s) [1]
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2444 - Port Macquarie
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2139 - Sydney
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Recruitment postcode(s) [4]
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2747 - Sydney
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Recruitment postcode(s) [5]
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NSW 2485 - Tweed Heads
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Recruitment postcode(s) [6]
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2500 - Wollongong
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Recruitment postcode(s) [7]
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4029 - Brisbane
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Recruitment postcode(s) [8]
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4120 - Greenslopes
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
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3121 - Richmond
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Recruitment postcode(s) [11]
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5065 - Terrace Gardens
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Recruitment postcode(s) [12]
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7000 - Hobart
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Recruitment postcode(s) [13]
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3550 - Bendigo
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Recruitment postcode(s) [14]
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3084 - Heidelberg
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Recruitment postcode(s) [15]
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3002 - Melbourne
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Recruitment postcode(s) [16]
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3690 - Wodonga
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Recruitment postcode(s) [17]
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva
and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients,
or patients with ECOG performance status of 2, with advanced non-small cell lung
cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on
days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine
monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00940875
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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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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00940875
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