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

NCT01774721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2023-11-14

Study results available
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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.

Conditions

  • Non-small Cell Lung Cancer With EGFR-Activating Mutations

Interventions

DRUG

Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.

DRUG

Gefitinib

Gefitinib 250 mg tablets, continuous oral daily dosing.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-09
Primary Completion
2016-07-29
Completion
2022-01-27

Countries

  • China
  • Hong Kong
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774721 on ClinicalTrials.gov