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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01360554

Run by

Pfizer

People needed

878

Starts

2011-06-16

Expected to finish

2015-09-14

Last updated by the study team

2017-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Northwest Alabama Cancer Center — Florence, Alabama, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States
• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States
• Ironwood physicians P C dba Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Chandler, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Gilbert, Arizona, United States
• Desert Oncology Associates dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States
• Highlands Oncology Group PA — Fayetteville, Arkansas, United States
• Highlands Oncology Group, PA — Rogers, Arkansas, United States
• Central Hematology Oncology Medical Group Inc. — Alhambra, California, United States
• UCLA Hematology Oncology-Alhambra — Alhambra, California, United States
• City of Hope — Duarte, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• Drug Management Only — Los Angeles, California, United States
• Drug Managerrent Only: — Los Angeles, California, United States
• UCLA West Medical Pharmacy — Los Angeles, California, United States
• Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU) — Los Angeles, California, United States
• Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• Regulatory Management Only: — Los Angeles, California, United States
• Regulatory Management: — Los Angeles, California, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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