CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
Dacomitinib (PF-00299804) +1 moredrug
Likely dose
Dacomitinib (PF-00299804) 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01774721
NCT01774721Phase 3Completed
CompareCT.gov

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)

Pfizer·interventional·Posted Jan 24, 2013·Updated Nov 14, 2023

In Brief

A Phase 3 clinical trial evaluating Dacomitinib (PF-00299804) and Gefitinib for Non-small Cell Lung Cancer With EGFR-Activating Mutations. Completed, enrolled 452 participants across 52 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer With EGFR-Activating Mutations
CountriesChina, Hong Kong, Italy, Japan, Poland, South Korea, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 24, 2013
Enrollment StartMay 9, 2013
Primary CompletionJul 29, 2016
Study CompletionJan 27, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.4 years ago

Interventions

Dacomitinib (PF-00299804)drug

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

Gefitinibdrug

Gefitinib 250 mg tablets, continuous oral daily dosing.