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Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer

NCT ID: NCT04736173

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2027-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer Nonsquamous Non Small Cell Lung Cancer Squamous Non Small Cell Lung Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A - Study Part 1 (Platinum-based Chemotherapy)

Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Paclitaxel

Intervention Type DRUG

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Pemetrexed

Intervention Type DRUG

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Arm B - Study Part 1 (Zimberelimab Monotherapy)

Participants will receive zimberelimab monotherapy by IV infusion.

Group Type EXPERIMENTAL

Zimberelimab

Intervention Type DRUG

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy)

Participants will receive zimberelimab in combination with AB154 by IV infusion.

Group Type EXPERIMENTAL

Domvanalimab

Intervention Type DRUG

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type DRUG

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy)

Participants will receive domvanalimab in combination with zimberelimab by IV infusion.

Group Type EXPERIMENTAL

Domvanalimab

Intervention Type DRUG

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Zimberelimab

Intervention Type DRUG

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Arm E - Study Part 2 (Pembrolizumab)

Participants will receive pembrolizumab by IV infusion.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

Interventions

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Domvanalimab

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Intervention Type DRUG

Zimberelimab

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Intervention Type DRUG

Carboplatin

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Intervention Type DRUG

Paclitaxel

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Intervention Type DRUG

Pemetrexed

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Intervention Type DRUG

Pembrolizumab

Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

Intervention Type DRUG

Other Intervention Names

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AB154 AB122

Eligibility Criteria

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Inclusion Criteria

* 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:

1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
2. 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.
3. Carcinomatous meningitis is excluded regardless of clinical stability.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences, Inc.

Locations

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Hope and Healing Cancer Service

Hinsdale, Illinois, United States

Site Status

General hospital of Athens, chest diseases Sotiria

Athens, , Greece

Site Status

University General Hospital "Attikon"

Chaïdári, , Greece

Site Status

General Oncology Hospital of Kifissia " Agioi Anargyroi"

Kifissia, , Greece

Site Status

General Hospital of Patra Agios Andreas

Pátrai, , Greece

Site Status

Hong Kong Integrated Oncology Centre

Hong Kong, , Hong Kong

Site Status

Hong Kong United Oncology Centre

Hong Kong, , Hong Kong

Site Status

Humanity and Health Clinical Trial Centre

Hong Kong, , Hong Kong

Site Status

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Hospital Sultan Ismail

Johor Bahru, , Malaysia

Site Status

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

Pantai Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, , Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Site Status

Hospital Umum Sarawak

Kuching, , Malaysia

Site Status

Hospital Pulau Pinang

Pulau Pinang, , Malaysia

Site Status

Mount Miriam Cancer Hospital

Pulau Pinang, , Malaysia

Site Status

Institut Kanser Negara

Putrajaya, , Malaysia

Site Status

Health Pharma Professional Research

Benito Juárez, , Mexico

Site Status

Hospital Civil Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status

Chong Hua Hospital

Cebu, , Philippines

Site Status

Metro Davao Medical and Research Centre

Davao City, , Philippines

Site Status

Makati Medical Centre

Manila, , Philippines

Site Status

Philippine General Hospital

Manila, , Philippines

Site Status

St. Luke Medical Centre Quezon City

Quezon City, , Philippines

Site Status

Exellentis Clinical Trial Consultants

George, , South Africa

Site Status

Cancercare PE

Johannesburg, , South Africa

Site Status

The Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

Site Status

Wits Clinical Research CMJAH Clinical Trial Site

Johannesburg, , South Africa

Site Status

Port Elizabeth Oncology Centre-Cancercare

Port Elizabeth, , South Africa

Site Status

University of Pretoria Medical Oncology

Pretoria, , South Africa

Site Status

Wilgers Oncology Centre

Pretoria, , South Africa

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

The Catholic University of Korea Incheon St. Mary's Hospital

Incheon, , South Korea

Site Status

Jeonbuk National University Hospital

Jeonju, , South Korea

Site Status

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status

Cha University Bundang Medical Center

Seongnam, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Gangnam Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, , South Korea

Site Status

Ajou University Hospital.

Suwon, , South Korea

Site Status

The Catholic University of Korea St. Vincent Hospital

Suwon, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Chang Gung Medical Foundation Kaohsiung

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status

Police General Hospital

Bangkok, , Thailand

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Vajira Hospital

Bangkok, , Thailand

Site Status

Saraburi Hospital

Changwat Sara Buri, , Thailand

Site Status

Prapokklao Hospital

Chanthaburi, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Nakornping Hospital

Chiang Mai, , Thailand

Site Status

Srinagarind Hospital

Khon Kaen, , Thailand

Site Status

Lampang Hospital

Lampang, , Thailand

Site Status

HRH Princess Maha Chakri Sirindhorn Medical Centre

Nakhon Nayok, , Thailand

Site Status

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, , Thailand

Site Status

Buddhachinaraj Phitsanulok Hospital

Phitsanulok, , Thailand

Site Status

Naresuan University Hospital

Phitsanulok, , Thailand

Site Status

Songkhlanagarind Hospital

Songkhla, , Thailand

Site Status

Sunpasitthiprasing Hospital

Ubon Ratchathani, , Thailand

Site Status

Udon Thani Hospital

Udon Thani, , Thailand

Site Status

Adana City Hospital

Adana, , Turkey (Türkiye)

Site Status

Ankara City Hospital

Adana, , Turkey (Türkiye)

Site Status

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Memorial Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status

Gazi University Medical Faculty

Çankaya, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Acibadem Atakent Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Medipol University Medical Facility

Istanbul, , Turkey (Türkiye)

Site Status

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Kocaeli Universitesi Tip Fakultesi

Kocaeli, , Turkey (Türkiye)

Site Status

Kocaeli Universitiesi Tip Fakultesi

Kocaeli, , Turkey (Türkiye)

Site Status

Dicle University, Medical faculty

Sur, , Turkey (Türkiye)

Site Status

103 Military Hospital

Hanoi, , Vietnam

Site Status

National Lung Hospital

Hanoi, , Vietnam

Site Status

Hue Central Hospital

Huế, , Vietnam

Site Status

Countries

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United States Greece Hong Kong Malaysia Mexico Philippines South Africa South Korea Taiwan Thailand Turkey (Türkiye) Vietnam

Related Links

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https://trials.arcusbio.com/study/?id=ARC-10

ARC-10 - Public Website

Other Identifiers

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2020-003562-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRR210222-003371

Identifier Type: OTHER

Identifier Source: secondary_id

2022-503071-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

ARC-10

Identifier Type: -

Identifier Source: org_study_id

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