Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer
ARC-10
Official Title: A Phase 2 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
4 other identifiers
interventional
169
10 countries
39
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Longer than P75 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedStudy Start
First participant enrolled
February 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 1, 2026
April 1, 2026
6.2 years
January 29, 2021
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
From randomization until death from any cause (up to 7 years)
Secondary Outcomes (3)
Overall Survival (OS)
From randomization until death from any cause (up to 7 years)
Confirmed Overall Response Rate (ORR)
From randomization until death from any cause (up to 7 years)
Number of Participants With treatment-emergent adverse events
From randomization until death from any cause (up to 7 years)
Study Arms (5)
Arm A - Study Part 1 (Platinum-based Chemotherapy)
ACTIVE COMPARATORParticipants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.
Arm B - Study Part 1 (Zimberelimab Monotherapy)
EXPERIMENTALParticipants will receive zimberelimab monotherapy by IV infusion.
Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)
EXPERIMENTALParticipants will receive zimberelimab in combination with AB154 by IV infusion.
Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)
EXPERIMENTALParticipants will receive domvanalimab in combination with zimberelimab by IV infusion.
Arm E - Study Part 2 (Pembrolizumab)
ACTIVE COMPARATORParticipants will receive pembrolizumab by IV infusion.
Interventions
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor
Eligibility Criteria
You may qualify if:
- 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 have at least 1 measurable lesion per RECIST v1.1
- Adequate organ and marrow function
- If a participant has brain or meningeal metastases, the participant must meet the following criteria:
- Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
- Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.
- Carcinomatous meningitis is excluded regardless of clinical stability.
You may not qualify if:
- Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
- Use of any live vaccines against infectious diseases within 28 days of first dose
- 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.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
- Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arcus Biosciences, Inc.lead
- Gilead Sciencescollaborator
Study Sites (39)
Research Site
Columbus, Georgia, 31904, United States
Research Site
Kingwood, Texas, 77339, United States
Research Site
Blacksburg, Virginia, 24014, United States
Research Site
Hong Kong, Hong Kong
Research Site
Johor Bahru, Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Kuantan, Malaysia
Research Site
Kuching, Malaysia
Research Site
Pulau Pinang, Malaysia
Research Site
Putrajaya, Malaysia
Research Site
Davao City, Philippines
Research Site
Manila, Philippines
Research Site
George, South Africa
Research Site
Johannesburg, South Africa
Research Site
Pretoria, South Africa
Research Site
Daegu, South Korea
Research Site
Incheon, South Korea
Research Site
Jinju, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
Research Site
Taichung, Taiwan
Research Site
Bangkok, Thailand
Research Site
Changwat Sara Buri, Thailand
Research Site
Chanthaburi, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Lampang, Thailand
Research Site
Nakhon Nayok, Thailand
Research Site
Nakhon Ratchasima, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Songkhla, Thailand
Research Site
Ubon Ratchathani, Thailand
Research Site
Adana, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Edirne, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Hanoi, Vietnam
Research Site
Huế, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 3, 2021
Study Start
February 8, 2021
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.