Thoracic Cancer MSK 19-199

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 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:

  1. Histologically confirmed NSCLC and histologically confirmed Stage IIB or IIIA NSCLC. (AJCC Version 8). Lymph node disease requires histologic confirmation, while T3 (rib destruction) disease requires only radiographic documentation.
  2. Be able to undergo protocol therapy, including necessary surgery.
  3. Does not have one of the following tumor locations/types:
    1. NSCLC involving the superior sulcus
    2. Large cell neuro-endocrine cancer (LCNEC)
    3. Sarcomatoid tumor
  4. No history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids
  5. Has no allogenic tissue/solid organ transplant.
  6. Not had active infection requiring systemic therapy.

This study is for patients age 18 and older.

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