An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer
- adult patients, >=18 years of age;
- advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
- no previous systemic chemotherapy, radiation therapy or immunotherapy;
- ECOG >=2.
- prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
- active, non-controlled systemic disease;
- any other malignancies within 5 years (except for adequately treated cancer in situ
of cervix, or basal or squamous cell skin cancer).
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression; pathological response rate.
Outcome Time Frame:
Romania: National Medicines Agency
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms