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

Stage IV Non-Small Cell Lung Cancer AJCC v7 Clinical Trial

Official title:
A Phase Ib Trial of Pembrolizumab (MK-3475) and Trametinib Focused on Advanced KRAS Mutant Non-small Cell Lung Cancer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03299088
Study type Interventional
Source University of California, Davis
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 26, 2018
Completion date June 2024
View Details
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