CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 878 enrolled
Drug / intervention
Dacomitinib (PF-00299804) +3 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/NCT01360554
NCT01360554Phase 3Completed
CompareCT.gov

Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

Pfizer·interventional·Posted May 25, 2011·Updated May 24, 2017

In Brief

A Phase 3 clinical trial evaluating Dacomitinib (PF-00299804), Active Comparator (erlotinib), and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 878 participants across 224 sites in 23 countries.

Detailed Summary

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesAustria, Belgium, China, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Japan, Mexico, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartJun 16, 2011
Primary CompletionSep 30, 2013
Study CompletionSep 14, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.1 years ago

Interventions

Dacomitinib (PF-00299804)drug

Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

Active Comparator (erlotinib)drug

Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

Placebo erlotinibdrug

placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

Placebo PF00299804drug

placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing