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Phase 2 Study of Dacomitinib in NSCLC

NCT04027647 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • NSCLC Stage IIIB
  • NSCLC Stage IIIC
  • NSCLC Stage IV
  • Recurrent NSCLC
  • EGFR Positive Non-Small Cell Lung Cancer

Interventions

DRUG

Dacomitinib

30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Daniel Tan, BSc, MBBS, PhD · National Cancer Centre Singapore (Lead Sponsor)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Hong Kong
  • Malaysia
  • Singapore
  • South Korea
  • Thailand

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 NCT04027647 on ClinicalTrials.gov