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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2021
  • participants needed
    42
  • sponsor
    University of California, Davis
Updated on 26 May 2021
cancer
tyrosine
monoclonal antibodies
measurable disease
international normalized ratio
KRAS
prothrombin
progressive disease
neutrophil count
tumor cells
pembrolizumab
recurrent non-small cell lung cancer
squamous non-small cell lung cancer

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of pembrolizumab (MK-3475) when given in combination with trametinib in the proposed sequencing schemes in patients with advanced or metastatic non-small cell lung cancer with KRAS mutations.

SECONDARY OBJECTIVES:

To assess in a preliminary manner the clinical efficacy of these combinations with the proposed sequencing schemes including overall response rate and progression free survival.

TERTIARY OBJECTIVES:

To determine in an exploratory manner changes in PD-L1 expression as well as other immune correlates induced by mitogen-activated extracellular signal-regulated kinase (MEK) inhibition.

Details
Condition 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, 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, 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, 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, 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, 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, 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, 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, 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
Treatment laboratory biomarker analysis, Pembrolizumab, Trametinib
Clinical Study IdentifierNCT03299088
SponsorUniversity of California, Davis
Last Modified on26 May 2021

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