ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2015-09-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Evidence of pathologically confirmed, advanced NSCLC (with known histology).

• Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).

• Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.

• Adequate renal, hematologic, liver function.

• ECOG PS of 0-2.

• Radiologically measurable disease.

Exclusion Criteria:

• Small cell histology.

• Symptomatic brain mets or known leptomeningeal mets.

• Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.

• Uncontrolled medical disorders.