ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC
ClinicalTrials.gov ID: NCT01774721
Sponsor: Pfizer
Information provided by: Pfizer (Responsible Party)
Last Update Posted: 2023-11-14
Brief Summary:
This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.
Detailed Description:
452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.
Official Title:
ARCHER 1050: A Randomized, Open-Label Phase 3 Efficacy and Safety Study Of Dacomitinib (PF-00299804) Vs. Gefitinib For The First-Line Treatment Of Locally Advanced or Metastatic NSCLC In Subjects With EGFR-Activating Mutations
Intervention / Treatment:
- Drug: Dacomitinib (PF-00299804)
- Drug: Gefitinib
| Category | Value |
|---|---|
| Study Start (Actual) | 2013-05-09 |
| Primary Completion (Actual) | 2016-07-29 |
| Study Completion (Actual) | 2022-01-27 |
| Enrollment (Actual) | 452 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
A7471050
DP312804 (Other Identifier) (OTHER: Pfizer) |