NCT05435846

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

A Multicenter Phase I/Ib Study of Capmatinib Plus Trametinib in Patients With Metastatic MET Exon 14 Skipping Mutation Positive NSCLC

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Collin Blakely · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/Ib trial studies the side effects and best doses of capmatinib plus trametinib when given together for the treatment of patients with MET exon 14 skipping mutation non-small cell lung cancer that has spread to other places in the body (metastatic). Capmatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Trametinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Capmatinib and trametinib are "targeted therapies." These targeted therapies work by detecting and targeting a mutation in the MET gene. Giving Capmatinib and trametinib may kill more tumor cells in patients with metastatic non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To identify recommended phase II dose (RP2D) of capmatinib in combination with trametinib in non-small cell lung cancer (NSCLC) with MET 14 exon mutation, MET amplification, or MET fusion (Phase I). II. To further characterize the safety profile of the RP2D of capmatinib in combination with trametinib in MET-exon14 mutated NSCLC (Phase Ib). SECONDARY OBJECTIVES: I. To further characterize the safety profile of the combination of capmatinib and trametinib in NSCLC with MET exon 14 mutation, MET amplification, or MET fusion (Phase I). II. To determine preliminary efficacy ofcapmatinib in combination with trametinib in MET-exon14 mutated NSCLC (Phase Ib) EXPLORATORY OBJECTIVES: I. To evaluate the pharmacokinetics of capmatinib in combination with trametinib. II. To identify biomarkers of response to capmatinib and trametinib. III. To identify mechanisms of resistance tocapmatinib and trametinib. OUTLINE: This is a phase I dose-escalation study of capmatinib and trametinib followed by a phase Ib dose expansion study. Patients receive capmatinib orally (PO) twice daily (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 12 months

Conditions

• Metastatic Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer

Interventions

Type	Name	Description
DRUG	Capmatinib	Given orally
DRUG	Trametinib	Given orally

Timeline

• Start date: 2022-08-10
• Primary completion: 2023-11-30
• Completion: 2024-05-31
• First posted: 2022-06-28
• Last updated: 2024-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study