Open Actively Recruiting

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
No
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

Join this Trial

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Study Stats
Protocol No.
20-000483
Category
Hematology-Oncology
Oncology
Contact
Karla Russell
Location
  • TRIO-US - Ft. Wayne IN
  • TRIO-US - Los Alamitos CA
  • TRIO-US - Redondo Beach
  • UCLA Beverly Hills
  • UCLA Encino
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA Pasadena
  • UCLA Porter Ranch
  • UCLA San Luis Obispo
  • UCLA Santa Monica
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
For Providers
NCT No.
NCT03906071
For detailed technical eligibility, visit ClinicalTrials.gov.