Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title: A Phase I Trial of Atezolizumab and Varlilumab in Combination With Radiation in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status Active, not recruiting

Clinical Trial Summary

This phase I trial studies the side effects of atezolizumab, varlilumab, and radiation therapy in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). 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. Immunotherapy with monoclonal antibodies such as varlilumab may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving atezolizumab, varlilumab, and radiation therapy may increase the amount of time the disease is not active or does not spread to another part of the body.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To assess the safety and tolerability of combined therapy with atezolizumab and varlilumab in combination with radiation in adult patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on prior PD-1/PD-L1 therapy.

SECONDARY OBJECTIVES:

I. To determine objective response rate (excluding the irradiated lesion) of therapy with atezolizumab and varlilumab in combination with radiation.

II. To estimate clinical benefit rate of the combination. III. To estimate median progression-free survival of the combination. IV. To compare the frequency of immune-related adverse events (irAEs).

OUTLINE:

Patients receive varlilumab intravenously (IV) oand atezolizumab IV every 3 weeks or each cycle. Between cycle 1 and 2, patients also receive stereotactic body radiation therapy (SBRT).

After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 1 year. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Refractory Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

• NCT number: NCT04081688
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 11, 2019
• Completion date: April 30, 2024