Actively Recruiting
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Led by Dwight Owen · Updated on 2026-02-27
24
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
D
Dwight Owen
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed recurrent or metastatic non-small cell lung cancer of any histology without curative options
- Measurable disease according to RECIST v1.1
- Prior standard chemotherapy and/or immunotherapy received, including PD-1 or PD-L1 therapies
- For adenocarcinoma with actionable mutations, all FDA-approved treatments must have been received
- ECOG performance status of 0 to 2
- Absolute neutrophil count of at least 1,500/mcL without growth factor support
- Platelet count of at least 100,000/uL without transfusion
- Hemoglobin level of at least 90 g/L (9 g/dL), transfusions allowed to meet this
- Creatinine clearance of at least 60 mL/min if creatinine is 1.5 times upper limit normal or less
- Serum total bilirubin 1.5 times upper limit normal or less, with exceptions for Gilbert disease
- Direct bilirubin at or below upper limit normal if total bilirubin is elevated
- AST and ALT up to 2.5 times upper limit normal, or up to 5 times if liver metastases present
- Alkaline phosphatase up to 2.5 times upper limit normal, or up to 5 times if liver or bone metastases present
- Albumin level of at least 2.5 g/dL
- INR or prothrombin time 1.5 times upper limit normal or less unless on anticoagulants within therapeutic range
- Activated partial thromboplastin time 1.5 times upper limit normal or less unless on anticoagulants within therapeutic range
- Life expectancy of 3 months or more
- Willingness to comply with study procedures
- Negative pregnancy test for women of childbearing potential at screening and during study visits
- Agreement to use effective contraception or abstain from heterosexual intercourse during and after treatment
- Ability to understand and sign informed consent
- Availability of recent tumor tissue sample obtained within 1 year
- Willingness to provide tissue from on-treatment biopsy if possible
- Negative HIV test or stable HIV with undetectable viral load
- Negative hepatitis B and C tests or controlled infection
You will not qualify if you...
- Active autoimmune disease requiring treatment or immune deficiency, except stable autoimmune hypothyroidism, controlled type 1 diabetes, or mild controlled dermatologic conditions
- Participation in another investigational study or treatment within 4 weeks prior to this trial
- Immunodeficiency or systemic steroid therapy over 10 mg prednisone or equivalent within 14 days prior to treatment
- Cirrhosis with significant complications
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Pregnancy, breastfeeding, or intention to become pregnant during or soon after treatment
- Conditions or therapies that interfere with trial participation or safety
- History of severe lung inflammation or active pneumonitis
- Known active tuberculosis
- Significant cardiovascular disease within 3 months prior to treatment
- Major surgery within 4 weeks prior to treatment or planned during the study
- Severe infections or recent therapeutic antibiotic use
- Prior allogeneic stem cell or solid organ transplant
- Use of live attenuated vaccines within 4 weeks before and during the study and for 5 months after last atezolizumab dose
- Treatment with systemic immunostimulatory agents within 4 weeks prior to treatment
- Severe allergic reactions to similar antibodies or components
- Unacceptable toxicity from prior checkpoint inhibitor therapy including severe immune-related adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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