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

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.

Timeline

Start

2019-07-15

Primary completion

2023-03-20

Completion

2025-09-30

Outcome

Missed primary endpoint

Stopped: “Inability to meet protocol objectives”

registry analysis (superiority test); Nivolumab and Sitravatinib vs Docetaxel; p = 0.144; Hazard Ratio (HR) 0.86 (95% CI 0.70 to 1.05) NCT03906071 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Subject	Sitravatinib	Small molecule	—	Oral

Indications