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NCT04736173

PHASE2

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

Sponsor: Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

169

Start Date

2021-02-08

Completion Date

2027-05

Last Updated

2026-03-30

Healthy Volunteers

Conditions

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

Interventions

DRUG

Domvanalimab

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

DRUG

Zimberelimab

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

DRUG

Carboplatin

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

DRUG

Paclitaxel

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

DRUG

Pemetrexed

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

DRUG

Pembrolizumab

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

Key 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. Key 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (56)

John B. Amos Cancer Center

Columbus, Georgia, United States

Lumi Cancer Institute

Kingwood, Texas, United States

Oncology and Hematology Associates of Southwest Virginia, Inc.

Blacksburg, Virginia, United States

Hong Kong United Oncology Centre

Hong Kong, Hong Kong

Humanity and Health Clinical Trial Centre

Hong Kong, Hong Kong

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Hospital Pulau Pinang

Pulau Pinang, Malaysia

Institut Kanser Negara

Putrajaya, Malaysia

Metro Davao Medical And Research Center Inc.

Davao City, Philippines

Philippine General Hospital

Manila, Philippines

St Luke's Medical Center

Manila, Philippines

Exellentis Clinical Trial Consultants

George, South Africa

Cancercare PE

Johannesburg, South Africa

University of Pretoria Medical Oncology

Pretoria, South Africa

Wilgers Oncology Centre

Pretoria, South Africa

Keimyung University

Daegu, South Korea

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

Incheon, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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

Seoul, South Korea

The Catholic University of Korea St. Vincent Hospital

Suwon, South Korea

China Medical University Hospital

Taichung, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Phramongkutklao Hospital

Bangkok, Thailand

Police General Hospital

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Vajira Hospital

Bangkok, Thailand

Saraburi Hospital

Changwat Sara Buri, Thailand

Prapokklao Hospital

Chanthaburi, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Nakornping Hospital

Chiang Mai, Thailand

Srinagarind Hospital

Khon Kaen, Thailand

Lampang Hospital

Lampang, Thailand

HRH Princess Maha Chakri Sirindhorn Medical Centre

Nakhon Nayok, Thailand

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, Thailand

Buddhachinaraj Phitsanulok Hospital

Phitsanulok, Thailand

Songkhlanagarind Hospital

Songkhla, Thailand

Sunpasitthiprasing Hospital

Ubon Ratchathani, Thailand

Adana City Hospital

Adana, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Acibadem Atakent Hospital

Istanbul, Turkey (Türkiye)

Medipol University Medical Faculty

Istanbul, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kocaeli, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey (Türkiye)

National Lung Hospital

Hanoi, Vietnam

Hue Central Hospital

Huế, Vietnam

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)