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Monoclonal Antibodies

Combination Immunotherapies for Non-Small Cell Lung Cancer (ARC-7 Trial)

Phase 2
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations
Male or female participants; age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death from any cause (up to approximately 3-5 years)
Awards & highlights

ARC-7 Trial Summary

This trial will study the safety and effectiveness of two different immunotherapy treatments for people with non-small cell lung cancer.

Who is the study for?
This trial is for adults over 18 with untreated, advanced non-small cell lung cancer showing high PD-L1 expression and no EGFR or ALK tumor mutations. Participants must be relatively healthy (ECOG score of 0 or 1) and have at least one measurable lesion. They shouldn't have had other active cancers in the last two years, recent vaccines, surgeries, certain viral infections like Hepatitis B/C or HIV, gastrointestinal issues affecting oral medication intake, or require high doses of steroids.Check my eligibility
What is being tested?
The study tests zimberelimab alone and in combination with domvanalimab; plus a third group receives both drugs combined with etrumadenant. It's an open-label phase 2 trial where patients are randomly assigned to these treatments to assess their safety and effectiveness against metastatic lung cancer that expresses PD-L1.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions as these therapies target the immune system to fight cancer cells. This can sometimes cause inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's resources, digestive disturbances due to changes in gut function by medications.

ARC-7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is untreated, spreads, has high PD-L1, and no EGFR or ALK changes.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs and bone marrow are working well.

ARC-7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to approximately 3-5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause (up to approximately 3-5 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)
Progression-free survival (PFS)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Immunogenicity of domvanalimab
+6 more

ARC-7 Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)Experimental Treatment3 Interventions
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Group II: Arm 2 (domvanalimab and zimberelimab combination therapy)Experimental Treatment2 Interventions
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Group III: Arm 1 (zimberelimab monotherapy)Experimental Treatment1 Intervention
Participants will receive zimberelimab as an intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etrumadenant
2018
Completed Phase 1
~130
Zimberelimab
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
6,336 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
837,378 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,769 Previous Clinical Trials
8,062,630 Total Patients Enrolled

Media Library

Domvanalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04262856 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm 1 (zimberelimab monotherapy), Arm 2 (domvanalimab and zimberelimab combination therapy), Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT04262856 — Phase 2
Domvanalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262856 — Phase 2

Frequently Asked Questions

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

What are the potential side effects of Zimberelimab?

"Zimberelimab's safety is based on Phase 2 trial data, which means that while there is some evidence of its safety, there is no guarantee of its efficacy. Therefore, it received a score of 2."

Answered by AI

Can more people still join this clinical trial?

"No, this specific trial is not actively seeking patients at this time. Although, it should be noted that the last update to this study was on November 8th, 2022 and there are currently 2239 other medical trials recruiting volunteers."

Answered by AI

Is this trial limited to a specific region or country?

"Presently, this study is taking place in 50 different clinics. These are situated in cities such as Bethesda, Greenville and New Orleans - amongst others. If you're considering participating, it would be most convenient to choose a location near to you to avoid extensive travel."

Answered by AI

What are the goals of this trial?

"The primary outcome metric for this study, which will be followed over the next 3 to 5 years, is progression-free survival. Additionally, the secondary outcomes include pharmacokinetics of domvanalimab and overall survival. Furthermore, researchers will also evaluate the number of patients that experience treatment emergent adverse events."

Answered by AI
~27 spots leftby Feb 2025