|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|
|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.|
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Non-Small Cell Lung Cancer|
- 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
- Ramalingam SS, O'Byrne K, Boyer M, Mok T, Jänne 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. Erratum in: Ann Oncol. 2016 Jul;27(7):1363.
- Ramalingam SS, Jänne 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.
|September 14, 2015|
|September 30, 2013 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Sexes Eligible for Study:||All|
|18 Years and older (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Austria, Belgium, China, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States|
2010-022656-22 ( EudraCT Number )
|Study Director:||Pfizer CT.gov Call Center||Pfizer|