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Clinical Trials in Turkey / NCT04736173
Active, not recruiting Phase 2

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

NCT04736173 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 2
Started
2021-02-08
Last updated
2026-08-31

Condition(s) studied

Non Small Cell Lung CancerNonsquamous Non Small Cell Lung CancerSquamous Non Small Cell Lung CancerLung Cancer

Investigational drug(s) / intervention(s)

Domvanalimab →Zimberelimab →Carboplatin →Paclitaxel →Pemetrexed →Pembrolizumab →

Domvanalimab: Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

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

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

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

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

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Research Site Columbus Georgia
Research Site Kingwood Texas
Research Site Blacksburg Virginia
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

On this site

📄 Keytruda (pembrolizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04736173 on ClinicalTrials.gov ↗ ← All trials in Turkey