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

Completed · Phase 3

Conditions studied: Metastatic Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03906071

Run by

Mirati Therapeutics Inc.

People needed

577

Starts

2019-07-15

Expected to finish

2025-09-30

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clearview Cancer Institute - Huntsville — Huntsville, Alabama, United States
• Palo Verde Cancer Specialists - Glendale — Glendale, Arizona, United States
• The Oncology Institute of Hope & Innovation - Tucson — Tucson, Arizona, United States
• Yuma Regional Medical Center — Yuma, Arizona, United States
• Local Institution - 005-174 — Jonesboro, Arkansas, United States
• NEA Baptist Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• Highlands Oncology Group - Springdale — Springdale, Arkansas, United States
• Comprehensive Blood and Cancer Center - Bakersfield — Bakersfield, California, United States
• Local Institution - 005-118 — Beverly Hills, California, United States
• Local Institution - 005-171 — Fresno, California, United States
• Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton — Fullerton, California, United States
• Local Institution - 005-096 — Long Beach, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
• Local Institution - 005-185 — Los Angeles, California, United States
• Local Institution - 005-072 — Newport Beach, California, United States
• Local Institution - 005-109 — Northridge, California, United States
• Local Institution - 005-177 — Redlands, California, United States
• Local Institution - 005-112 — Riverside, California, United States
• University of California San Francisco — San Francisco, California, United States
• Local Institution - 005-176 — San Marcos, California, United States
• Local Institution - 005-192 — Torrance, California, United States
• Local Institution - 005-090 — West Covina, California, United States
• Local Institution - 005-105 — Whittier, California, United States
• Local Institution - 005-164 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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