Trials / Active Not Recruiting
Active Not RecruitingNCT04027647
Phase 2 Study of Dacomitinib in NSCLC
A Single-arm, Open-label, Phase 2 Study of Dacomitinib With or Without Dose Titration for the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Subjects With an Epidermal Growth Factor Receptor (EGFR) Activation Mutation
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- National Cancer Centre, Singapore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-11
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2019-07-22
- Last updated
- 2025-06-12
Locations
9 sites across 5 countries: Hong Kong, Malaysia, Singapore, South Korea, Thailand
Source: ClinicalTrials.gov record NCT04027647. Inclusion in this directory is not an endorsement.