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

Official Title

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

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.

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
Secondary Outcome:
  • Recommended phase 2 dose
  • Incidence of adverse events
This study will have two parts: Phase I
  • During this part, also called the dose de-escalation part, an initial group of 6 participants will receive a certain planned dose of binimetinib in addition to a standard dose of pembrolizumab. If this combination is found to be safe during the first 28 days of receiving the study drugs, this will be considered the most appropriate dose of the study drug combination (the highest dose of binimetinib that can be given with pembrolizumab without causing serious side effects). Phase Ib
  • Once the appropriate dose of binimetinib is confirmed in Phase I (as described above), additional participants will be enrolled in the Phase Ib to further test how safe, tolerable, and effective the study drugs at that dose level. Phase Ib will also evaluate the anti-tumour activity of binimetinib and pembrolizumab in participants with advanced non-small cell lung cancer.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society