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

Sponsor
University Health Network, Toronto
Study ID
NCT03991819
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Non-small Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Binimetinib — DRUG
    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.
  • Pembrolizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 19, 2019
Start date
Sep 20, 2019
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    Cycle 1 = 28 days and Cycle 2 and Future Cycles = 21 days Binimetinib, by mouth (orally): Level 1: 45 mg, twice a day, continuously; Level -1: 30 mg, twice a day, continuously; Level -2: 30 mg, twice a day, for Days 1-14 of each cycle only Pembrolizumab, by vein (intravenously), at a dose of 200 mg on Day 8 of Cycle 1, then Day 1 of Cycle 2 and future cycles.
  • Experimental: Phase 1b
    All Cycles = 21 days Binimetinib, by mouth (orally), at the best dose found in Phase 1 of the study, twice a day, continuously. Pembrolizumab, by vein (intravenously), at a dose of 200 mg on Day 1 of every cycle.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 2 years ]

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