Domvanalimab + Zimberelimab vs Pembrolizumab for Lung Cancer
(ARC-10 Trial)

Recruiting in Palo Alto (17 mi)

+507 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Arcus Biosciences, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase 2 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) in front-line, PD-L1-high, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).

Eligibility Criteria

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.

Inclusion Criteria

My advanced lung cancer has high PD-L1 levels, confirmed by a specific test.

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

My brain metastases are stable, and I haven't needed steroids for them in over 14 days.

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Exclusion Criteria

I have not received any live vaccines in the last 28 days.

I have been treated with drugs targeting the immune system.

I haven't had any cancer except for minor ones like skin or superficial bladder cancer in the last 2 years.

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Treatment Details

Interventions

Carboplatin (Anti-cancer agent)
Domvanalimab (PD-L1 Inhibitor)
Paclitaxel (Anti-cancer agent)
Pembrolizumab (PD-L1 Inhibitor)
Pemetrexed (Anti-cancer agent)
Zimberelimab (PD-L1 Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.