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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360554
First received: April 12, 2011
Last updated: September 8, 2014
Last verified: September 2014

April 12, 2011
September 8, 2014
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01360554 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 12 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Progression-Free Survival per Investigator [ Time Frame: 4 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Best Overall Response [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 6 months from LSLV until progression ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status [ Time Frame: 6 months from LSLV ] [ Designated as safety issue: No ]
  • KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline [ Time Frame: baseline, and 12 months from LSLV ] [ Designated as safety issue: No ]
  • PK trough concentrations [ Time Frame: 12 months from LSLV ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Progression-Free Survival per Investigator [ Time Frame: 4 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Best Overall Response [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 6 months from LSLV until progression ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status [ Time Frame: 6 months from LSLV ] [ Designated as safety issue: No ]
  • KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline [ Time Frame: baseline, and 12 months from LSLV ] [ Designated as safety issue: No ]
  • PK trough concentrations [ Time Frame: 12 months from LSLV ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 + placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
    Other Name: Dacomitinib (PF-00299804)
  • Drug: Active Comparator (erlotinib)
    Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing + placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing.
  • Experimental: A
    Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
    Intervention: Drug: Dacomitinib (PF-00299804)
  • Active Comparator: B
    Blinded active comparator (erlotinib) + blinded placebo PF-00299804
    Intervention: Drug: Active Comparator (erlotinib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
September 2014
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Austria,   Belgium,   China,   Denmark,   Finland,   France,   United Kingdom,   Greece,   Hungary,   India,   Ireland,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland
 
NCT01360554
A7471009
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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