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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Trial Status: Active

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.

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

California

San Francisco
UCSF Medical Center-Mission Bay
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Hawaii

Honolulu
Straub Clinic and Hospital
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Christopher Baierl
Phone: 913-588-3058

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: systems coordinator
Phone: 215-214-1558

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Mirati Therapeutics

  • Primary ID 516-005
  • Secondary IDs NCI-2019-02881
  • Clinicaltrials.gov ID NCT03906071