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Protocol No. UW19057

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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 Therapy Inhibitor (SAPPHIRE)

Objective This study will compare the effectiveness of sitravatinib in combination with nivolumab versus docetaxel in subjects with non-small cell lung cancer who have previously had progression on or after chemotherapy in combination with immunotherapy

Treatment
Sitravatinib 120 mg once daily and should be taken on an empty stomach at least 2 hours after the previous meal and 1 hour before the next meal with Nivolumab either the standard flat dose of 240 mg intravenously every 2 weeks or the standard flat dose of 480 mg intravenously every 4 weeks. The infusions will last about 30 minutes OR
Docetaxel 75 mg/m2 given by intravenous once every 3 weeks

Description Phase 3 study of Sitravatinib plus Nivolumab versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

Key Eligibility
  • Histologically confirmed non-squamous NSCLC with metastatic or unresectable, locally advanced disease, not amenable to treatment with curative intent
  • Receipt of prior first-line treatment in the advanced disease setting with a platinum-based chemotherapy regimen in combination with a CIT (i.e., anti-PD-1 or anti-PD-L1 including nivolumab, pembrolizumab, or atezolizumab), with the result of radiographically documented progression of disease on or after the combination regimen. First-line treatment may have included maintenance therapy with a chemotherapy agent (e.g., pemetrexed) and/or a CIT and duration of treatment on prior CIT at least 4 months.
  • Candidacy to receive treatment with docetaxel as the next line of therapy if randomized to the comparator arm
  • At least 18 years of age or older
  • ECOG perforance staus of 0-1
  • Adequate bone marrow and organ function as defined by the protocol
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION
  • Discontinuation of prior treatment with CIT more than 90 days prior to the date of randomization
  • Receipt of systemic cancer therapy since discontinuation of CIT, with the exception of maintenance chemotherapy in the first-line treatment setting
  • Active brain metastases. Patients are eligible if brain metastases are adequately treated and patients are neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment) for at least 2 weeks prior to enrollment without the use of anticonvulsants and without the use of corticosteroids (or are on a stable or decreasing dose of less than or equal to 10 mg daily prednisone or equivalent)
  • Carcinomatous meningitis
  • Known history of tumors that test positive for EGFR, ROS1, ALK mutations, or ALK fusions
  • Prior therapies: Immunotherapies not previously specified, including anti-CTLA-4, anti-OX40 and anti–CD137 and cancer therapy having the same mechanism of action as sitravatinib (e.g., tyrosine kinase inhibitor with a similar target profile or bevacizumab)
  • Known toxicity on prior checkpoint inhibitor treatment
  • Active or prior documented autoimmune disease: Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
  • Active or prior immunocompromising conditions: Known acute or chronic human immunodeficiency virus (HIV), history of primary immunodeficiency, or history of allogeneic transplant
  • Need for treatment with gastric pH modifying medications including proton pump inhibitors and/or H2 antagonist medications. Patients may switch to use of antacids
  • Known acute or chronic hepatitis B or hepatitis C. Patients treated for hepatitis C with no detectable viral load are permitted
  • History of stroke or transient ischemic attack within the previous 6 months
  • History of significant hemoptysis or hemorrhage within 4 weeks of first dose date
  • Can not be pregnant or breastfeeding

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics