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ARCHER 1009 : A Study Of Daco...

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

Last Updated: 2017-05-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-16

Study Completion Date

2015-09-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

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

Group Type EXPERIMENTAL

Dacomitinib (PF-00299804)

Intervention Type DRUG

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

Placebo erlotinib

Intervention Type DRUG

placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

B

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

Group Type ACTIVE_COMPARATOR

Active Comparator (erlotinib)

Intervention Type DRUG

Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

Placebo PF00299804

Intervention Type DRUG

placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Interventions

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Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

Intervention Type DRUG

Active Comparator (erlotinib)

Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

Intervention Type DRUG

Placebo erlotinib

placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

Intervention Type DRUG

Placebo PF00299804

placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Northwest Alabama Cancer Center

Florence, Alabama, United States

Site Status

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, United States

Site Status

Ironwood physicians P C dba Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Site Status

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Site Status

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Gilbert, Arizona, United States

Site Status

Desert Oncology Associates dba Ironwood Cancer and Research Centers

Mesa, Arizona, United States

Site Status

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

Mesa, Arizona, United States

Site Status

Highlands Oncology Group PA

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group, PA

Rogers, Arkansas, United States

Site Status

Central Hematology Oncology Medical Group Inc.

Alhambra, California, United States

Site Status

UCLA Hematology Oncology-Alhambra

Alhambra, California, United States

Site Status

City of Hope

Duarte, California, United States

Site Status