ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated May 24, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Dacomitinib (PF-00299804); Drug: Active Comparator (erlotinib); Drug: Placebo erlotinib; Drug: Placebo PF00299804
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Northwest Alabama Cancer CenterFlorence, Alabama
- University of South Alabama Mitchell Cancer InstituteMobile, Alabama
- University of South Alabama Medical CenterMobile, Alabama
- Northwest Alabama Cancer CenterMuscle Shoals, Alabama
- Ironwood physicians P C dba Ironwood Cancer & Research CentersChandler, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandler, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGilbert, Arizona
- Desert Oncology Associates dba Ironwood Cancer and Research CentersMesa, Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersMesa, Arizona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 24, 2017. Always confirm current availability with the study team.