Clinical trial · Interventional
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator (erlotinib) | Drug | — | UNRESOLVED |
| Dacomitinib (PF-00299804) | Drug | — | UNRESOLVED |
| Placebo erlotinib | Drug | — | UNRESOLVED |
| Placebo PF00299804 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
- interventionNames
- Drug: Dacomitinib (PF-00299804)
- Drug: Placebo erlotinib
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Blinded active comparator (erlotinib) + blinded placebo PF-00299804
- interventionNames
- Drug: Active Comparator (erlotinib)
- Drug: Placebo PF00299804
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) Per Independent Radiologic Review.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDBreen DM, Joaquim S, Paulhus BL, Bennett D, Bernardo B, Collins S, Esquejo RM, Kim-Muller JY, Lin L, Peloquin M, Wu Z, Qiao S, Stansfield JC, Zhang BB, Rossulek MI. Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70312. doi: 10.1002/jcsm.70312. PMID 42126170
- DERIVEDRamalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13. PMID 26768165
- DERIVEDRamalingam SS, Janne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15. PMID 25439691