ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | September 2015 |
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
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.
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.
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.
We found this trial at
103
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Los Angeles, California 90095
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Los Angeles, California 90095
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University of Louisville The University of Louisville is a state supported research university located in...
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1660 Springhill Avenue
Mobile, Alabama 36604
Mobile, Alabama 36604
(251) 665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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Oklahoma City, Oklahoma 73120
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Florida Hospital Florida Hospital is one of the country
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Barnes Jewish Hospital Barnes-Jewish Hospital at Washington University Medical Center is the largest hospital in...
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 638-1000
Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
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