Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer (nsclc)
Treatments dacomitinib (pf-00299804), active comparator (erlotinib)
Phase phase 3
Sponsor Pfizer
Start date June 2011
End date September 2013
Trial size 800 participants
Trial identifier NCT01360554, A7471009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
dacomitinib (pf-00299804) Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing + placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
(Active Comparator)
Blinded active comparator (erlotinib) + blinded placebo PF-00299804
active comparator (erlotinib)
Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing + placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing.

Primary Outcomes

Measure
Progression Free Survival per Independent Radiologic review in two co-primary populations.
time frame: 10 months after anticipated LSLV

Secondary Outcomes

Measure
Overall Survival
time frame: 12 months after anticipated LSLV
Progression-Free Survival per Investigator
time frame: 4 months after anticipated LSLV
Best Overall Response
time frame: 6 months after
Duration of Response
time frame: 6 months from LSLV until progression
Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 months
time frame: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV
Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status
time frame: 6 months from LSLV
KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline
time frame: baseline, and 12 months from LSLV
PK trough concentrations
time frame: 12 months from LSLV

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title ARCHER 1009: A Randomized, Double Blind Phase 3 Efficacy and Safety Study Of PF-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-Small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Pfizer.