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

NCT03906071 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2025-10-21

Study results available
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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.

Conditions

  • Metastatic Non-Squamous Non-Small Cell Lung Cancer

Interventions

BIOLOGICAL

Nivolumab

Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.

DRUG

Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

DRUG

Docetaxel

Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2023-03-20
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906071 on ClinicalTrials.gov