Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib | Drug | Lapatinib | ALIAS |
| trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lapatinib + trametinib
- description
- lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
- interventionNames
- Drug: Lapatinib
- Drug: trametinib
Primary outcomes (3)
- measure
- Incidence rate of dose-limiting toxicities
- timeFrame
- 1.5 years
- measure
- progression free survival
- timeFrame
- 2.5 years
- measure
- overall response rate
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only. * Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20) * Age ≥ 18 years * Able and willing to give written informed consent * WHO performance status of 0 or 1 (part A and B) Exclusion Criteria: * Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment. * History of another primary malignancy * Symptomatic or untreated leptomeningeal disease * Symptomatic brain metastasis * History of interstitial lung disease or pneumonitis * Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients * Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment * Patients with left ventricular ejection fraction (LVEF) \< 50%
References
Publications (0)
Data not yet available