Title: Phase I/II study of the CDK4/6 inhibitor palbociclib (PD-0332991) in combination with the MEK inhibitor binimetinib (MEK162) for patients with advanced KRAS mutant non-small cell lung cancer

Principal Investigator: Geoffrey Shapiro, MD, PhD, of Dana-Farber Cancer Institute

Description: Researchers are conducting a phase 1/2 trial to test palbociclib and binimetinib, alone and in combination, in patients with advanced KRAS-mutant non-small cell lung cancer (NSCLC).


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In phase 1, patients will receive palbociclib orally once daily for 3 weeks of each 4-week cycle. They will also receive binimetinib orally twice daily throughout each cycle. 

In phase 2, patients will be assigned to 1 of 3 treatment arms. Patients in the first arm will receive palbociclib plus binimetinib on the aforementioned schedule. In the second and third arm, patients will receive either drug alone. 

Primary outcomes include the maximum tolerated dose, safety and tolerability, and progression-free survival at 4 months. Secondary outcomes include pharmacokinetics, target engagement of palbociclib and binimetinib in pre-treatment and on-treatment tumor biopsies, and objective response.

To be eligible for this study, patients must be 18 years of age or older. They must also have advanced KRAS-mutant NSCLC with no known curative treatment options. For a complete list of eligibility criteria, please see the reference.

Status: Recruiting

This study is sponsored by Dana-Farber Cancer Institute in collaboration with Pfizer and Array BioPharma.

ReferenceClinicalTrials.gov. Study of the CDK4/6 inhibitor palbociclib (PD-0332991) in combination with the MEK inhibitor binimetinib (MEK162) for patients with advanced KRAS mutant non-small cell lung cancer. NCT03170206. Accessed July 25, 2022.