A Phase Ib Study of Vismodegib and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer (ML43922)
Dwight Owen
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of the combination of vismodegib and atezolizumab in patients with advanced NSCLC based upon the Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. SECONDARY OBJECTIVE: I. To determine the efficacy of the combination of vismodegib and atezolizumab in patients with advanced NSCLC, including progression-free survival (PFS), objective response (ORR), disease control rate (DCR), and overall survival (OS) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. EXPLORATORY OBJECTIV…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 adenocarcinoma and known actionable mutations with Food and Drug Administration (FDA) approved treatment options must have received all approved and standard of care treatment options (i.e. osimertinib for epiderm…
Interventions
- BiologicalAtezolizumab
Given IV
- ProcedureBiospecimen Collection
Undergo tissue and blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugVismodegib
Given PO
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio