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Clinical trial

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC

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Last updated:13th Nov 2023
Status: COMPLETED
Identifier: NCT01774721
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)

 


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