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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Collaborator: Bristol-Myers Squibb
• Treatments: Docetaxel; Nivolumab

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