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

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Must not have

Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications

Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death from any cause (up to approximately 3-5 years)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking high doses of steroids or medications that suppress my immune system.

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I can take oral medications without issues like swallowing difficulty or severe nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death from any cause (up to approximately 3-5 years)

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.