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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 12, 2011
Last updated: January 4, 2016
Last verified: January 2016

April 12, 2011
January 4, 2016
June 2011
September 2013   (Final data collection date for primary outcome measure)
Progression Free Survival per Independent Radiologic review in two co-primary populations. [ Time Frame: 10 months after anticipated LSLV ]
Same as current
Complete list of historical versions of study NCT01360554 on Archive Site
  • 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 ]
Same as current
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ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer (NSCLC)
  • Drug: Dacomitinib (PF-00299804)
    Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
  • Drug: Active Comparator (erlotinib)
    Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
  • Drug: Placebo erlotinib
    placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
  • Drug: Placebo PF00299804
    placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing
  • Experimental: A
    Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
    • Drug: Dacomitinib (PF-00299804)
    • Drug: Placebo erlotinib
  • Active Comparator: B
    Blinded active comparator (erlotinib) + blinded placebo PF-00299804
    • Drug: Active Comparator (erlotinib)
    • Drug: Placebo PF00299804

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   China,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
Hong Kong
2010-022656-22 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Study Director: Pfizer Call Center Pfizer
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP