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

Part of paid clinical trials in San Francisco, California.

Sponsor
Collin Blakely
Study ID
NCT05435846
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capmatinib — DRUG
    Given orally
  • Trametinib — DRUG
    Given orally

Study Details

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.

Key Dates

Start date
Aug 10, 2022
Status verified
Jun 2024
Primary completion
Nov 30, 2023
Completion
May 31, 2024

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Escalation
    Patients receive 200 - 400 mg capmatinib orally, twice a day and 1.0 or 1.5 mg trametinib orally once a day on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 1b: Dose Expansion
    Patients will receive the recommended phase 2 dose (RP2D) or capmatinib in combination with trametinib determined by the safety profile of the Phase 1 group. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of participants with reported dose limiting toxicity (DLT) (Phase I) [ Time Frame: 1 cycle (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CA

Related Studies