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

NCT03906071

CompletedPhase 3

Sponsor: Mirati Therapeutics Inc.

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

Interventions: Nivolumab, Sitravatinib, Docetaxel

Countries: United States, Belgium, Canada, France, Germany, Hungary, Israel, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (261)
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Glendale, Arizona, United States
  • Tucson, Arizona, United States
  • Yuma, Arizona, United States
  • Jonesboro, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Springdale, Arkansas, United States
  • Bakersfield, California, United States
  • Beverly Hills, California, United States
  • Fresno, California, United States
  • Fullerton, California, United States
  • Long Beach, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • Redlands, California, United States
  • Riverside, California, United States
  • San Francisco, California, United States
  • San Marcos, California, United States
  • Torrance, California, United States
  • West Covina, California, United States
  • Whittier, California, United States
  • Lafayette, Colorado, United States
  • Norwich, Connecticut, United States
  • Fort Lauderdale, Florida, United States
  • Fort Myers, Florida, United States
  • Hollywood, Florida, United States
  • + 231 more on CT.gov