Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations

Part of paid clinical trials in Sacramento, California.

Sponsor: Jonathan Riess
Study ID: NCT03299088
Phase: PHASE1
Status: Completed

Conditions

KRAS Gene Mutation
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Recurrent Non-Squamous Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer AJCC v7

Eligibility Criteria

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

Interventions

Pembrolizumab — BIOLOGICAL
Given IV
Trametinib — DRUG
Given PO

Study Details

This phase Ib trial studies the side effects of pembrolizumab and trametinib in treating patients with non-small cell lung cancer and KRAS gene mutations that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and trametinib may work better in treating patients with non-small cell lung cancer.

Key Dates

Start date: Jun 26, 2018
Status verified: May 2025
Primary completion: Jan 28, 2021
Completion: Jun 25, 2024

Study Design

Enrollment: 15 participants (actual)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Arm A (trametinib, pembrolizumab)
Patients receive trametinib PO daily. Beginning on day 1 of course 2, patients also receive pembrolizumab IV over 30 minutes. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (pembrolizumab, trametinib)
Patients receive pembrolizumab IV over 30 minutes on day 1. Beginning on day 1 of course 2, patients also receive trametinib PO daily. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of Dose-limiting Toxicity (DLT) of Pembrolizumab and Trametinib Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 6 weeks ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	-

Related coverage on Hipa.ai

Pembrolizumab and Trametinib in KRAS-mutated NSCLC Phase 1 Safety Profile
Pembrolizumab · May 21, 2025 · ClinicalTrials.gov

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By research site

University of California Davis Comprehensive Cancer Center· Sacramento, CA