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.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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.
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.
Exclusion Criteria:
- active brain metastasis or spinal cord suppression;
- unstable systemic disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
tumour assessment after every 2nd 4-week cycle
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: National Health and Medical Research Council
Study ID:
ML22429
NCT ID:
NCT00940875
Start Date:
June 2009
Completion Date:
January 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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