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ARCHER 1009 : A Study Of PF-00299804 (Dacomitinib) 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: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC)
 Drug: Dacomitinib (PF-00299804)
Drug: Active Comparator (erlotinib)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival per Independent Radiologic review in two co-primary populations. [ Time Frame: 10 months after anticipated LSLV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
 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)
Active Comparator: B
Blinded active comparator (erlotinib) + blinded placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360554

  Show 203 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01360554     History of Changes
Other Study ID Numbers: A7471009
Study First Received: April 12, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
comparative study of PF-00299804 and Erlotinib
Double-Blind Phase 3 trial of TKI

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013