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

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.

Timeline

Start

2011-06-16

Primary completion

2013-09-30

Completion

2015-09-14

Outcome

Missed primary endpoint

registry p = 0.195; Hazard Ratio (HR) 0.933 (95% CI 0.797 to 1.093) NCT01360554 ↗

registry p = 0.643; Hazard Ratio (HR) 1.037 (95% CI 0.848 to 1.268) NCT01360554 ↗

Publications

• Breen 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.
• Ramalingam 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.
• Ramalingam 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DACOMITINIB ANHYDROUS	Small molecule	45 mg	Oral
Comparator	Erlotinib	Small molecule	150 mg	Oral

Indications