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Anti-cancer agent
Domvanalimab + Zimberelimab vs Pembrolizumab for Lung Cancer (ARC-10 Trial)
Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death from any cause (up to approximately 7 years)
Awards & highlights
ARC-10 Trial 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.Check my eligibility
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.See study design
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.
ARC-10 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced lung cancer has high PD-L1 levels, confirmed by a specific test.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
ARC-10 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death from any cause (up to approximately 7 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death from any cause (up to approximately 7 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Confirmed Overall Response Rate (ORR)
Number of Participants With treatment-emergent adverse events
Progression-free Survival (PFS)
+1 moreARC-10 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 2
~2010
Zimberelimab
2018
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,897 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,672 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,777 Previous Clinical Trials
8,063,317 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any live vaccines in the last 28 days.I have been treated with drugs targeting the immune system.My advanced lung cancer has high PD-L1 levels, confirmed by a specific test.I haven't had any cancer except for minor ones like skin or superficial bladder cancer in the last 2 years.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.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.My tumor has a specific mutation that can be treated with approved targeted therapy.My organs and bone marrow are working well.You must have at least one area of disease that can be measured according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - Study Part 1 (Platinum-based Chemotherapy)
- Group 2: Arm B - Study Part 1 (Zimberelimab Monotherapy)
- Group 3: Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)
- Group 4: Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)
- Group 5: Arm E - Study Part 2 (Pembrolizumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved the second portion of Arm E - Study utilizing pembrolizumab?
"Based on available evidence, it is our team's assessment that Arm E - Study Part 2 (Pembrolizumab) has a safety score of 3. Phase 3 trials have generated results demonstrating safety and efficacy."
Answered by AI
What kind of conditions does Arm E - Study Part 2 (Pembrolizumab) typically target?
"Arm E - Study Part 2 (Pembrolizumab) has been observed to be successful in treating palliative therapy, malignant peritoneal neoplasm, and advanced endometrial cancer."
Answered by AI
How many participants are there in this research endeavor?
"Affirmative. Digging into clinicaltrials.gov confirms that the trial, which was first published on February 8th 2021, is still actively enrolling individuals. 750 participants need to be recruited from 441 different medical sites around the world."
Answered by AI
Is this medical research still recruiting participants?
"Affirmative. Clinicaltrials.gov mentions that this clinical trial, which was initially uploaded on February 8th 2021, is currently recruiting patients. Approximately 750 individuals need to be enrolled from 441 distinct medical sites."
Answered by AI
How many venues is this clinical experiment conducted in?
"This clinical trial has enrolled 441 patients from numerous locations, such as the University of Pretoria Medical Oncology in Pretoria and Affinity Health Hope & Healing Cancer Services in Hinsdale. Other sites are also included."
Answered by AI
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