Clinical Trial

Phase 2 Study of Dacomitinib in NSCLC

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated June 12, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC). National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-07-18; most recent amendment 2025-06-10.
Status change: Recruiting → Active, Not Recruiting 2022-11-24
Status change: Not Yet Recruiting → Recruiting 2020-03-10
Trial Details
NCT Number NCT04027647
Lead Sponsor National Cancer Centre, Singapore
Collaborators: Pfizer
Conditions NSCLC Stage IIIB, NSCLC Stage IIIC, NSCLC Stage IV, Recurrent NSCLC, EGFR Positive Non-Small Cell Lung Cancer
Enrollment 118 participants
Start Date 2019-09-11
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-12