OncRef

Clinical Trial: NCT01774721

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Pfizer
Information Provided By:Pfizer
Last Update Posted:2023-11-14

Study Overview

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.

Official Title

ARCHER 1050: A RANDOMIZED, OPEN-LABEL, PHASE 3, EFFICACY AND SAFETY STUDY OF DACOMITINIB (PF-00299804) VERSUS GEFITINIB FOR THE FIRST LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER IN SUBJECTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ACTIVATING MUTATION(S)

Conditions

Non-small Cell Lung Cancer With EGFR-Activating Mutations

Intervention / Treatment

  • Drug: Dacomitinib (PF-00299804)
  • Drug: Gefitinib

Other Study ID Numbers

  • A7471050
  • DP312804

Start Date (Actual)

2013-05-09

Primary Completion Date (Actual)

2016-07-29

Study Completion Date (Actual)

2022-01-27

Enrollment (Actual)

452

Study Type

Interventional

Phase

Phase 3