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Anti-cancer agent

Domvanalimab + Zimberelimab vs Pembrolizumab for Lung Cancer (ARC-10 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, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Must not have
Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint
Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combo drug to treat advanced lung cancer, compared to a current drug.

Who is the study for?
This trial is for adults with untreated, advanced non-small cell lung cancer that shows high PD-L1 expression. They must have good organ function and at least one measurable tumor lesion. Those with stable brain metastases may qualify, but not if they have autoimmune diseases requiring recent treatment or other active cancers within the last two years.
What is being tested?
The study compares a new combination of drugs (Domvanalimab and Zimberelimab) against an established drug (Pembrolizumab), all alongside standard chemotherapy agents like Carboplatin and Paclitaxel to treat lung cancer. It's designed to see which regimen works better in first-line therapy.
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms, possible impact on blood cells leading to increased infection risk, fatigue, and complications from underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced lung cancer has high PD-L1 levels, confirmed by a specific test.
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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 have been treated with drugs targeting the immune system.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.
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My tumor has a specific mutation that can be treated with approved targeted therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm E - Study Part 2 (Pembrolizumab)Experimental Treatment1 Intervention
Participants will receive pembrolizumab by IV infusion.
Group II: Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)Experimental Treatment2 Interventions
Participants will receive domvanalimab in combination with zimberelimab by IV infusion.
Group III: Arm B - Study Part 1 (Zimberelimab Monotherapy)Experimental Treatment1 Intervention
Participants will receive zimberelimab monotherapy by IV infusion.
Group IV: Arm A - Study Part 1 (Platinum-based Chemotherapy)Active Control3 Interventions
Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.
Group V: Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)Active Control2 Interventions
Participants will receive zimberelimab in combination with AB154 by IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Zimberelimab
2019
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
43 Previous Clinical Trials
7,023 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,137 Previous Clinical Trials
867,730 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,905 Previous Clinical Trials
8,091,320 Total Patients Enrolled

Media Library

Carboplatin (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT04736173 — Phase 2
Lung Cancer Research Study Groups: Arm A - Study Part 1 (Platinum-based Chemotherapy), Arm B - Study Part 1 (Zimberelimab Monotherapy), Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy), Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy), Arm E - Study Part 2 (Pembrolizumab)
Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04736173 — Phase 2
Carboplatin (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736173 — Phase 2
~62 spots leftby May 2027
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