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A2R Antagonist

Triple Combination Immunotherapy for Lung Cancer

Phase 2

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 5 years)

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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,930 Previous Clinical Trials

2,298,937 Total Patients Enrolled

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

6,036 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this experiment thus far?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which was first introduced on August 4th 2021 is presently recruiting participants. The study seeks to enlist thirty people from a single medical centre."

Answered by AI

Are individuals being enrolled in this trial presently?

"Affirmative. Research hosted on clinicaltrials.gov reveals that this investigation, which was initially published on August 4th 2021, is still accepting participants. Approximately 30 individuals are needed to be sourced from 1 location."

Answered by AI

To what extent could Zimberelimab be detrimental to patients?

"Considering the drug is in a Phase 2 trial, with some evidence of safety but no proof of efficacy yet, our team at Power rated Zimberelimab's safety as a 2 on their rating scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer

2021. "Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04791839.