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A2R Antagonist

Triple Combination Immunotherapy for Lung Cancer

Phase 2
Waitlist Available
Led By Daniel Morgensztern, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented PD-L1 expression of at least 1% by a US FDA-approved PD-L1 assay or using the clone 22C3 antibody from archival biopsy or fresh tumor tissue
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 5 years)
Awards & highlights

Study Summary

This trial will test the efficacy of a triple combination therapy for lung cancer patients who have previously been treated with other immunotherapy.

Who is the study for?
This trial is for adults with non-small cell lung cancer who've had previous treatments including immune checkpoint blockers. They must have at least one measurable tumor and cannot have more than two prior therapies in the metastatic setting. Participants need normal organ function, no severe psychiatric issues or substance abuse, not be pregnant/breastfeeding, and can't have certain other cancers or active autoimmune diseases.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Zimberelimab, Domvanalimab, and Etrumadenant on patients with non-small cell lung cancer who didn't respond well to previous treatments. It explores how these drugs work together since they target different aspects of the immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune-based cancer therapies such as fatigue, skin reactions, inflammation in various organs (like lungs or intestines), hormonal gland problems (like thyroid dysfunction), infusion-related reactions and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer shows PD-L1 expression of 1% or more.
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I am 18 years old or older.
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I've had 1-2 treatments for my cancer, including an immune therapy.
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My lung cancer is confirmed to be advanced and of a specific type.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Number of discontinuations due to treatment-related adverse events
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Zimberelimab + Domvanalimab + EtrumadenantExperimental Treatment3 Interventions
Patients will be treated on 21-day cycles with 360 mg zimberelimab intravenously on Day 1, 15 mg/kg domvanalimab intravenously on Day 1, and 150 mg etrumadenant orally daily on Days 1 to 21. Cohort B participants are those that have PD-L1 ≥ 50%.
Group II: Cohort A: Zimberelimab + Domvanalimab + EtrumadenantExperimental Treatment3 Interventions
Patients will be treated on 21-day cycles with 360 mg zimberelimab intravenously on Day 1, 15 mg/kg domvanalimab intravenously on Day 1, and 150 mg etrumadenant orally daily on Days 1 to 21. Cohort A participants are those that have PD-L1 1-49%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Etrumadenant
2018
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,945 Previous Clinical Trials
2,303,790 Total Patients Enrolled
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,067 Total Patients Enrolled
Daniel Morgensztern, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

Domvanalimab (A2R Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04791839 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort B: Zimberelimab + Domvanalimab + Etrumadenant, Cohort A: Zimberelimab + Domvanalimab + Etrumadenant
Non-Small Cell Lung Cancer Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT04791839 — Phase 2
Domvanalimab (A2R Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791839 — Phase 2
~5 spots leftby Jan 2025
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