A Phase 3 Study Of PF-00299804, A Pan-HER Inhibitor, Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
Phase 3
Completed
- Conditions
- Health Condition 1: null- Non-Small Cell Lung Cancer (NSCLC)
- Registration Number
- CTRI/2012/03/002486
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
1.Evidence of pathologically confirmed, advanced NSCLC (with known histology).
2.Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
3.Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
4.Adequate renal, hematologic, liver function.
5.ECOG PS of 0-2.
6.Radiologically measurable disease.
Exclusion Criteria
1.Small cell histology.
2.Symptomatic brain mets or known leptomeningeal mets.
3.Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
4.Uncontrolled medical disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method