Trial Information
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
Inclusion Criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable
disease ;
- ECOG PS 2;
- adequate organ function.
Exclusion Criteria:
- prior chemotherapy or systemic anti-tumor therapy;
- hypersensitivity to erlotinib;
- any condition contraindicating the use of the study medication and/or impairing the
interpretation of results and/or leading to treatment-related complications.
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:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: Cancer Trials Australia, Royal Melbourne Hospital
Study ID:
ML20063
NCT ID:
NCT00518011
Start Date:
August 2007
Completion Date:
July 2009
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms