Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
About
Brief Summary
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
20-000483
Category
Hematology-Oncology
Oncology
Principal Investigator
Location
- TRIO-US - Ft. Wayne IN
- TRIO-US - Los Alamitos CA
- TRIO-US - Redondo Beach