PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Completed
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Registration Number
- NCT01659970
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
- Patients for whom the treating physician has decided to initiate treatment with Tarceva
Exclusion Criteria
- Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
- Current participation in a clinical trial evaluating an anticancer treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival 2 years
- Secondary Outcome Measures
Name Time Method Clinical/demographic patients characteristics at baseline 2 years Treatment schedules: Dose/duration/modifications/interruptions 2 years Overall survival 2 years Safety: Incidence of adverse events 2 years Quality of life: FACT-L version 4 questionnaire 2 years