Trials / Completed
CompletedNCT02230553
Lapatinib Plus Trametinib in KRAS Mutant NSCLC
Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant Non-small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lapatinib | |
| DRUG | trametinib |
Timeline
- Start date
- 2014-10-07
- Primary completion
- 2019-07-29
- Completion
- 2019-08-06
- First posted
- 2014-09-03
- Last updated
- 2025-07-08
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02230553. Inclusion in this directory is not an endorsement.