NCT04081688

Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Atezolizumab 1200 MG in 20 ML Injection	Given IV every 3 weeks (cycle is 21 days)
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
DRUG	Varlilumab 3 mg/kg	Given IV every 3 weeks (cycle is 21 days)

Timeline

• Start date: 2019-09-11
• Primary completion: 2022-04-27
• Completion: 2024-04-30
• First posted: 2019-09-09
• Last updated: 2026-02-05
• Results posted: 2023-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study