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

NCT01360554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2017-05-24

Study results available
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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.

Conditions

Interventions

DRUG

Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

DRUG

Active Comparator (erlotinib)

Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

DRUG

Placebo erlotinib

placebo 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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-16
Primary Completion
2013-09-30
Completion
2015-09-14

Countries

  • United States
  • Austria
  • Belgium
  • China
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Japan
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360554 on ClinicalTrials.gov