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

NCT01360554

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
    Interventions:
    • Drug: Dacomitinib (PF-00299804)
    • Drug: Placebo erlotinib
  • Active Comparator: B
    Blinded active comparator (erlotinib) + blinded placebo PF-00299804
    Interventions:
    • Drug: Active Comparator (erlotinib)
    • Drug: Placebo PF00299804
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
878
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2011)
800
Actual Study Completion Date  ICMJE September 14, 2015
Actual Primary Completion Date September 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT01360554
Other Study ID Numbers  ICMJE A7471009
2010-022656-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2017

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