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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 · ARCHER 1009 Phase 3Completed

Lead sponsor
Pfizer (Industry)
Enrollment
878 (actual)
Start date
16 Jun 2011
Primary completion
30 Sep 2013 (actual)
Study completion
14 Sep 2015
Last update posted
24 May 2017

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Dacomitinib (PF-00299804) Drug
  • Active Comparator (erlotinib) Drug
  • Placebo erlotinib Drug
  • Placebo PF00299804 Drug

Conditions and primary outcome

  • Non-Small Cell Lung Cancer

Primary outcome

Progression-Free Survival (PFS) Per Independent Radiologic Review. (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.); Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT01360554 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-Free Survival (PFS) Per Independent Radiologic Review.

    Time frame
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
    Measure
    Median
    Unit
    Months

    • Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)Superiority or other

      Estimate
      0.933Hazard Ratio (HR)
      95% CI, two-sided
      0.797 to 1.093
      p-value
      0.195
      Method
      1-sided stratified log-rank test

  2. Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.

    Time frame
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.
    Measure
    Median
    Unit
    Months

    • Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo) vs Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)Superiority or other

      Estimate
      1.037Hazard Ratio (HR)
      95% CI, two-sided
      0.848 to 1.268
      p-value
      0.643
      Method
      1-sided stratified log-rank test

Serious adverse events

Time frame: AE reporting period is from 1st dose of study drug through 28 days after last dose of study drug. SAE reporting period is from informed consent through 28 days after last dose of study drug. The longest duration of treatment in this study was 48 weeks.

Participants with serious adverse events per group for ARCHER 1009, as posted
GroupAffectedAt risk
Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)178436
Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)169436

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

3 on PubMed

  1. Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies.

    Journal of cachexia, sarcopenia and muscle · 2026 Jun

    PubMed 42126170 (opens in a new tab)DOI 10.1002/jcsm.70312 (opens in a new tab)

  2. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2016 Mar

    PubMed 26768165 (opens in a new tab)DOI 10.1093/annonc/mdv593 (opens in a new tab)

  3. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial.

    The Lancet. Oncology · 2014 Nov

    PubMed 25439691 (opens in a new tab)DOI 10.1016/S1470-2045(14)70452-8 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.