Lapatinib Plus Trametinib in KRAS Mutant NSCLC
- Registration Number
- NCT02230553
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lapatinib + trametinib Lapatinib lapatinib: oral tablets, once daily trametinib: oral tablets, once daily lapatinib + trametinib trametinib lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
- Primary Outcome Measures
Name Time Method overall response rate 2.5 years progression free survival 2.5 years Incidence rate of dose-limiting toxicities 1.5 years
- Secondary Outcome Measures
Name Time Method Duration of response 2.5 years Incidence and severity of adveres events 2.5 years Plasma concentration 2.5 years Time to response 2.5 years Overall survival 3 years
Trial Locations
- Locations (1)
The Netherlands Cancer Institute
🇳🇱Amsterdam, Netherlands