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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

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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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