NCT06616623

Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

A Phase Ib Study of Vismodegib and Atezolizumab in Patients With Advanced Non-Small Cell Lung Cancer (ML43922)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Dwight Owen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 OBJECTIVE: I. To study the effect of vismodegib on the levels of M2-TAMs and CD8+ T cells within the tumor microenvironment (TME) as well as myeloid-derived suppressor cells (MDSCs) in peripheral blood of study patients. OUTLINE: Patients receive vismodegib orally (PO) daily on days 1-28 and atezolizumab intravenously (IV) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Some patients undergo tissue sample collection during screening and on study. After completion of study treatment, patients are followed up every 12 weeks.

Conditions

• Metastatic Lung Non-Small Cell Carcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
PROCEDURE	Biospecimen Collection	Undergo tissue and blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Vismodegib	Given PO

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-12-31
• Completion: 2027-12-01
• First posted: 2024-09-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study