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
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)
Drug: Placebo erlotinib
Drug: Placebo PF00299804
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:

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 ]

Enrollment: 877
Study Start Date: June 2011
Study Completion Date: September 2015
Primary Completion Date: September 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
Drug: Placebo erlotinib
placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
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
Drug: Placebo PF00299804
placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01360554

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT01360554     History of Changes
Other Study ID Numbers: A7471009  2010-022656-22 
Study First Received: April 12, 2011
Last Updated: January 4, 2016
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 23, 2016