This phase Ib trial tests the safety, side effects, and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or has spread from where it first started (primary site) to other places in the body (metastatic). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a combination of vismodegib and atezolizumab may be safe, tolerable and/or effective than either drug alone in treating patients with recurrent or metastatic NSCLC.
Age ≥ 18 years
Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options
Measurable disease based on RECIST v1.1
Patients must have received standard of care chemotherapy and/or immunotherapy. No limits to prior lines of therapy. Prior PD-1 and/or PD-L1 directed therapies are permitted
Patients with a history of autoimmune-related hypothyroidism who are stable on thyroid-replacement hormone are eligible for the study
Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
Rash must cover ≤ 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids
Dwight Owen
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Genentech, Inc.
Collaborator