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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Active Comparator (erlotinib); Drug: Dacomitinib (PF-00299804); Drug: Placebo PF00299804; Drug: Placebo erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360554

A7471009

2010-022656-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 878 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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878 participants in 2 patient groups

A

Experimental group

Description:

Blinded active PF-00299804 + blinded placebo comparator (erlotinib)

Treatment:

Drug: Dacomitinib (PF-00299804)

Drug: Placebo erlotinib

B

Active Comparator group

Description:

Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Treatment:

Drug: Placebo PF00299804

Drug: Active Comparator (erlotinib)