RecruitingPhase 1NCT03991819

Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer

Phase I/Ib Study of Binimetinib, a MEK Inhibitor, in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Sep 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I/Ib study whose purpose is to find out if combining an experimental drug called binimetinib with pembrolizumab is beneficial in people who have advanced non-small cell lung cancer. This study may also see if the combination is safe and may also find the best dose of binimetinib that should be added to pembrolizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining binimetinib (a MEK inhibitor) with pembrolizumab (an immunotherapy) in patients with advanced non-small cell lung cancer (NSCLC) where the tumor strongly expresses the PD-L1 protein, suggesting it may respond to immunotherapy. **You may be eligible if...** - You have confirmed non-small cell lung cancer (NSCLC) at stage IV or advanced (incurable) stage III - Your tumor has a PD-L1 score of 50% or higher - Your tumor does not have EGFR mutations or ALK rearrangements (which have their own targeted therapies) - You have measurable disease on scans - You agree to provide a tumor tissue sample for genetic analysis **You may NOT be eligible if...** - Your tumor has neuroendocrine, small cell, or mixed small cell features - Your PDL-1 score is below 50% - You have EGFR mutations or ALK rearrangements - You are pregnant or unable to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBinimetinib

Binimetinib is a drug that, inside the cell, blocks an important series of chemical reactions called a molecular pathway. Binimetinib blocks the MEK1/2 pathway from working. In some types of cancers, this pathway becomes too active, which can cause tumor cell growth. Blocking the MEK1/2 pathway from working is thought to slow or stop tumor cell growth.

DRUGPembrolizumab

Pembrolizumab is an immunotherapy drug that is approved by Health Canada for the treatment of patients with PD-L1 positive non-small cell lung cancer as a first treatment. PD-1 is a type of protein that binds to another type of protein known as PD-L1. When these proteins bind together, it helps prevent cells from killing each other, including cancer cells. Some drugs, like pembrolizumab, are used to block PD-1 from binding to PD-L1. When the protein is blocked, the body's immune system can kill more cells.


Locations(4)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT03991819


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