Lung Cancer Trials Ask AI to find trials
CompletedPhase 3NCT01360554
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDacomitinib (PF-00299804) and Active Comparator (erlotinib)

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 24, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?224 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Pfizer
Interventions being studied
Drug: Dacomitinib (PF-00299804); Drug: Active Comparator (erlotinib); Drug: Placebo erlotinib; Drug: Placebo PF00299804
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • University of Alabama at BirminghamBirmingham, Alabama
  • University of Alabama at BirminghamBirmingham, Alabama
  • Northwest Alabama Cancer CenterFlorence, Alabama
  • University of South Alabama Mitchell Cancer InstituteMobile, Alabama
  • University of South Alabama Medical CenterMobile, Alabama
  • Northwest Alabama Cancer CenterMuscle Shoals, Alabama
  • Ironwood physicians P C dba Ironwood Cancer & Research CentersChandler, Arizona
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandler, Arizona
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGilbert, Arizona
  • Desert Oncology Associates dba Ironwood Cancer and Research CentersMesa, Arizona
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersMesa, Arizona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 24, 2017. Always confirm current availability with the study team.

View original record ↗