Status:
COMPLETED
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Partic...
Eligibility Criteria
Inclusion
- 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;
- Eastern Cooperative Oncology Group (ECOG) \>=2.
Exclusion
- prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (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).
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00701558
Start Date
August 1 2008
End Date
December 1 2010
Last Update
June 24 2016
Active Locations (1)
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1
Bucharest, Romania, 022328