Beverly Hills, California 90211

  • Small Cell Lung Cancer

Purpose:

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.


Study summary:

Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.


Criteria:

Inclusion Criteria: - Diagnosis of Non-Squamous Non-Small Cell Lung Cancer - Receipt of at least one but not more than two prior treatment regimens in the advanced setting - Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy) - Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment - Candidate to receive docetaxel as second or third line therapy Exclusion Criteria: - Uncontrolled brain metastases - Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions - Unacceptable toxicity with prior checkpoint inhibitor therapy - Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy - Impaired heart function


NCT ID:

NCT03906071


Primary Contact:

Study Director
Ronald L. Shazer, MD, MBA
Mirati Therapeutics Inc.

Mirati Therapeutics Study Locator Services
Phone: 1-844-893-5530 (toll free)
Email: miratistudylocator@emergingmed.com


Backup Contact:

N/A


Location Contact:

Beverly Hills, California 90211
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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