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Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC

NCT04081688 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-05

Study results available
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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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Jyoti Malhotra · Rutgers Cancer Institute of New Jersey

  • Salma Jabbour · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2022-04-27
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081688 on ClinicalTrials.gov