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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous NSCLC

NCT03906071

Description:

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 in combination with checkpoint inhibitor therapy.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous NSCLC
  • 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 in Combination With Checkpoint Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: 516-005
  • NCT ID: NCT03906071

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivoNivolumab and Sitravatinib
SitravatinibMGCD516Nivolumab and Sitravatinib
DocetaxelTaxotereDocetaxel

Purpose

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 in combination with checkpoint inhibitor therapy.

Detailed Description

      Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits
      several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT
      and MET. 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.
    

Trial Arms

NameTypeDescriptionInterventions
Nivolumab and SitravatinibExperimentalNivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally at 120 mg once daily.
  • Nivolumab
  • Sitravatinib
DocetaxelActive ComparatorDocetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Non-Squamous Non-Small Cell Lung Cancer

          -  Receipt of prior first-line treatment with platinum-based chemotherapy in combination
             with PD-1/PD-L1 checkpoint inhibitor therapy

          -  Adequate bone marrow and organ function

          -  Candidate to receive docetaxel as second 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 in the first-line setting

          -  Impaired heart function
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:36 Months
Safety Issue:
Description:OS is defined as time from date of randomization to date of death due to any cause

Secondary Outcome Measures

Measure:Adverse Events (AEs)
Time Frame:36 Months
Safety Issue:
Description:Frequency of patient experiencing treatment-emergent AEs
Measure:Objective Response Rate (ORR)
Time Frame:36 Months
Safety Issue:
Description:ORR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy
Measure:Progression-Free Survival (PFS)
Time Frame:36 months
Safety Issue:
Description:PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • Sitravatinib
  • Nivolumab
  • Docetaxel
  • Checkpoint inhibitor
  • MGCD516
  • NSCLC

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