Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT04081688
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 11, 2019
Status verified
Jan 2026
Primary completion
Apr 27, 2022
Completion
Apr 30, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (varlilumab, atezolizumab, SBRT)
    Patients receive varlilumab IV over 90 minutes and atezolizumab IV over 30-60 minutes every cycle. Cycles repeat every 21 days for up to 1 year (18 cycles) in the absence of disease progression or unacceptable toxicity. Between cycle 1 and 2, patients also receive SBRT.

Primary Outcome Measure

Number of Participants With Grade 3 and 4 Toxicity [ Time Frame: Up to 30 days after the last dose of treatment, an average of a year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-

Find similar trials in New Brunswick, NJ

By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJ

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