An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)
Completed
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- NCT01790217
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
- Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines
Exclusion Criteria
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival rate at 18 months 3.5 years
- Secondary Outcome Measures
Name Time Method Response rate (complete response/partial response) by type of mutation 3.5 years Percentage of patients with remission 3.5 years Progression-free survival (overall/stratified) 3.5 years Overall survival (overall/stratified) 3.5 years Tolerability: Incidence of fatigue, rash, diarrhea 3.5 years Safety: Incidence of serious adverse events 3.5 years Dose modifications/withdrawals 3.5 years Symptom control (cough, dyspnea) 3.5 years