Thoracic Cancer GO41892

PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS DOCETAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER PREVIOUSLY TREATED WITH AN ANTI-PD-L1/PD-1 ANTIBODY AND PLATINUM-CONTAINING CHEMOTHERAPY

 This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially.

Eligibility Criteria:

  • Histologically or cytologically confirmed mNSCLC
  • Documented radiographic disease progression during or following treatment with platinum-containing chemo and anti-PD-L1/PD-1 antibody (given concurrently or sequentially) for mNSCLC
    • If anti-PD-L1/PD-1 antibody and platinum-containing chemo given concurrently as first-line treatment for mNSCLC, no further lines of systemic anti-cancer therapy are allowed
    • If anti-PD-L1/PD-1antibody and platinum-containing chemo given sequentially as first and second lines, respectively, for mNSCLC, no further lines of systemic anti-cancer therapy are allowed
    • Combination therapies with other agents are allowed with anti-PD-L1/PD-1 and/or platinum-containing chemotherapy (see exclusion criteria for exceptions)
  • Measurable disease per RECIST v1.1 outside CNS as assessed by investigator
    • Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
  • Known PD-L1 status or availability of tumor tissue for central PD-L1 testing

This study is for patients age 18 and older.

Available at: Hartford HealthCare, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital.

Cancer Clinical Research Office