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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Progression Free Survival per Independent Radiologic review in two co-primary populations.

Outcome Time Frame:

10 months after anticipated LSLV

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471009

NCT ID:

NCT01360554

Start Date:

June 2011

Completion Date:

August 2013

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • comparative study of PF-00299804 and Erlotinib
  • Double-Blind Phase 3 trial of TKI
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteLebanon, New Hampshire  03766