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
Single group
Atezolizumab
Biological/VaccineGiven IV
Biospecimen Collection
Procedure/SurgeryUndergo tissue and blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Vismodegib
DrugGiven PO
Incidence of adverse events (AEs)
Will be the measured using the Common Terminology Criteria for Adverse Events version 5 criteria. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Incidence of dose limiting toxicity
Will be the measured using the Common Terminology Criteria for Adverse Events version 5 criteria. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Objective response rate
Will be calculated and exact binomial 95% confidence interval (CI) will be provided.
Disease control rate
Will be calculated and exact binomial 95% CI will be provided.
Overall survival (OS)
Kaplan-Meier methods will be used to estimate OS with 95% CI.
Progression free survival (PFS)
Kaplan-Meier methods will be used to estimate PFS with 95% CI.
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Dwight Owen
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Genentech, Inc.
Collaborator
