This study is in progress, not accepting new patients

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

a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Edward Garon (ucla)

Description

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.

Official Title

A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE

Details

Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Keywords

Metastatic Non-Squamous Non-Small Cell Lung Cancer, Sitravatinib, Nivolumab, Docetaxel, Checkpoint inhibitor, MGCD516, NSCLC, SAPPHIRE, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Nivolumab and Sitravatinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center
    Los Angeles California 90024 United States
  • University of California San Francisco
    San Francisco California 94518 United States
  • Beverly Hills Cancer Center
    Beverly Hills California 90211 United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach California 92663 United States
  • Los Angeles Hematology Oncology Medical Group
    Los Angeles California 90017 United States
  • Cancer and Blood Specialty Clinic
    Los Alamitos California 90720 United States
  • Torrance Memorial Physician Network - Cancer Care and Infusion Center
    Torrance California 90505 United States
  • Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
    Fullerton California 92835 United States
  • California Cancer Associates for Research and Excellence - San Marcos
    San Marcos California 92069 United States
  • The Oncology Institute of Hope and Innovation - Corona
    Corona California 92882 United States

Lead Scientist at University of California Health

  • Edward Garon (ucla)
    Professor, Medicine. Authored (or co-authored) 194 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT03906071
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 532 study participants
Last Updated