AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3STAR-121NCT05502237

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

A Phase 3 study testing Zimberelimab, Domvanalimab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Gilead Sciences at 186 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Zimberelimab, Domvanalimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,021 participants
Where
186 sitesin 23 countries
Study dates
12 Oct 2022to Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy ≥ 3 months.
  • Pathologically documented NSCLC that meets both of the criteria below:
  • Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
  • Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
  • Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
  • Have not received prior systemic treatment for metastatic NSCLC.
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  • Measurable disease per RECIST v1.1 criteria by investigator assessment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • Have adequate organ functions.

Who cannot join

  • Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
  • Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
  • Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
  • Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
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  • Are receiving chronic systemic steroids.
  • Have significant third-space fluid retention.
  • Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has had an allogenic tissue/solid organ transplant.
  • Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  • Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

186 sites in 23 countries.

186 sites in 23 countries

China22 sites

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Deyang People's Hospital

    Deyang, 618000

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Zhejiang Cancer Hospital

    Hangzhou, 310005

  • The Second Affiliated Hospital of Nanchang University

    Jiangxi, 330006

  • Shandong Cancer Hospital

    Jinan, 250021

  • Jiangxi Chest Hospital

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Guangxi Medical University Cancer Hospital

    Nanning, 530021

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Shanghai East Hospital

    Shanghai, 200120

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Cancer Hospital of Shantou University Medical College

    Shantou, 0754-88555844

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300181

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, 430030

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710049

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, 453100

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain20 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08041

  • Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

    Barcelona, 8028

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

  • Hospital Parc Tauli

    Barcelona, 8208

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital Universitario de Canarias

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28020

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

  • Hospital Sant Joan de Reus

    Reus, 43204

  • Hospital Regional Universitario de Malaga

    Rincón de la Victoria, 29011

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41014

  • Instituto Valenciano De Oncologia (IVO)

    Valencia, 46009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46015

  • Hospital Vithas Valencia 9 de Octubre

    Valencia, 46015

Other trials in Spain

Japan15 sites

  • National Cancer Center Hospital East

    Chiba, 277-0882

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kurume University Hospital

    Fukuoka, 830-0011

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Hyogo Cancer Center

    Hyōgo, 673-8558

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kanagawa Cancer Center

    Kanagawa, 241-0815

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka, 569-8686

  • Kindai University Hospital

    Osaka, 589-8511

  • National Hospital Organization Kinki Chuo Chest Medical Center

    Osaka, 591-8555

  • Saitama Medical University

    Saitama, 350-1298

Other trials in Japan

United States11 sites

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • Texas Oncology - Austin

    Austin, Texas, 78745

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Blacksburg, Virginia, 24060

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Hematology & Oncology Associates

    Eugene, Oregon, 97401

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20052

  • Innovative Clinical Research Institute

    Whittier, California, 90606

Other trials in United States

Brazil11 sites

  • Cenantron Centro Avançado de Tratamento Oncologico Ltda

    Belo Horizonte, 30130-090

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, 29308-014

  • Fundacao Universidade De Caxias Do Sul - FUCS/RS

    Caxias do Sul, 95070-560

  • Instituto do Câncer do Ceará - ICC

    Fortaleza, 60430-230

  • Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

    Ijuí, 98700-000

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital São Lucas da PUCRS

    Porto Alegre, 90610-000

  • Hospital Ana Nery Santa Cruz do Sul

    Santa Cruz do Sul, 96810-110

  • Instituto Brasiliero de Controle do Cancer IBCC

    São Paulo, 03102002

  • Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

    São Paulo, 17210080

Other trials in Brazil

Germany11 sites

  • Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik

    Cologne, 51109

  • Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

    Essen, 45122

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria Halle Dölau

    Halle, 06120

  • Asklepios Kliniken Hamburg

    Hamburg, 21075

  • Katholisches Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

    Hemer, 58675

  • Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

    Karlsruhe, 76137

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie

    Offenbach, 63069

Other trials in Germany

Italy10 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • AORN Cardarelli

    Naples, 80131

  • IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

    Pavia, 27100

  • Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

    Pesaro, 61122

  • Ospedale Guglielmo da Saliceto AUSL di Piacenza

    Piacenza, 29100

  • Centro di Riferimento Oncologico

    Pordenone, 33081

  • Regina Elena Institute for Cancer Research

    Rome, 00144

Other trials in Italy

France9 sites

  • Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

    Boulogne-Billancourt, 92100

  • Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

    Le Mans, 72000

  • Hopital Nord

    Marseille, 13005

  • Institut de Cancer de Montpellier (ICM) - Val d'Aurelle

    Montpellier, 34928

  • Institut de cancerologie de l'ouest (ICO)

    Saint-Herblain, 44805

  • Hopital d'Instruction des Armees (HIA) Begin

    Saint-Mandé, 94160

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 2100

  • Hôpital Foch

    Suresnes, 92150

  • CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

    Toulon, 83056

Other trials in France

Argentina8 sites

  • Investigaciones CORI S.R.L.

    Capital, F5300COE

  • Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

    Cardoba, X5008HHW

  • Sanatorio Allende

    Córdoba, 5000

  • Sanatorio Britanico de Rosario

    Rosario, 2000

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV

  • Hospital Provincial del Centenario

    Rosario, S2002KDS

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC

  • Clínica Viedma

    Viedma, 8500

Other trials in Argentina

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 500-06

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-DA Hospital

    Kaohsiung City, 824

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301

  • Chi Mei Hospital, Liouying

    Tainan, 736

  • Taipei Veterans General Hospital

    Taipei, 10002

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

    Taoyuan City, 33305

Other trials in Taiwan

Turkey (Türkiye)8 sites

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06550

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 6200

  • Trakya University Faculty of Medicine

    Edirne, 22030

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Fatih, 34098

  • Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34093

  • Medipol Mega University Hospital

    Istanbul

  • Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

    Kaakaekmece, 34303

  • Turgut Ozal Medical Faculty

    Malatya, 44300

Other trials in Turkey (Türkiye)

Chile7 sites

  • Clinica Alemana de Santiago

    Las Condes, 7550000

  • Clinica Puerto Montt

    Port Montt, 5500243

  • Orlandioncologia

    Providencia, 7500006

  • Oncovida- Santiago

    Providencia, 7510035

  • Biocinetic

    Santiago, 8331143

  • James Lind Centro de Investigacion del Cancer

    Temuco, 4800827

  • Oncocentro APYS

    Viña del Mar, 2520612

Other trials in Chile

Mexico7 sites

  • Health Pharma Professional Research S.A. de C.V.

    México, 3100

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Mitras Centro, 64460

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, 68020

  • Clinical Medical Research SC.

    Orizaba Centro, 94300

  • Clinica Integral Internacional de Oncologia S de RL de CV

    Puebla City, 72530

  • FAICIC Clínical Research

    Veracruz, 91900

Other trials in Mexico

South Korea7 sites

  • Samsung Medical Center

    Gangnam-Gu, 6351

  • National Cancer Center

    Goyang, 410769

  • Chungbuk National University Hospital

    Heungdeok-Gu, 361-711

  • Gachon University Gil Medical Center

    Inchon, 21565

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • The Catholic University of Korea, Saint Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

Portugal6 sites

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2720276

  • Instituto Português de Oncologia de Lisboa Francisco Gentil

    Lisbon, 1089

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • Hospital Beatriz Angelo. Hospital de Loures.

    Lisbon, 2674-514

  • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

    Lisbon

  • Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

    Senhora da Hora, 4464-513

Other trials in Portugal

Netherlands5 sites

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Ziekenhuis St Jansdal

    Harderwijk, 3844 DG

  • TweeSteden Ziekenhuis

    Tilburg

Other trials in Netherlands

Belgium4 sites

  • Algemeen Ziekenhuis Sint-Lucas

    Aalst, 9300

  • Grand Hopital de Charleroi asbl (GHdC)

    Charleroi, 6000

  • AZ Sint-Maarten

    Mechelen, 2800

  • CHU UCL Namur / Site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Canada4 sites

  • Centre Integre de sante et de services sociaux de la Monteregie Centre

    Greenfield Park, J4V 2H1

  • Moncton Hospital

    Moncton, E1C 6Z8

  • CISSS des Laurentides

    Québec, J7Z 2V4

  • Centre de santé et services sociaux de Rimouski-Neigette

    Rimouski, G5L5T1

Other trials in Canada

Israel4 sites

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

    Nahariya

  • Rabin Medical Center

    Petah Tikva, 49100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Austria3 sites

  • Ordensklinikum Linz GmbH, Elisabethinen

    Linz, 4020

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, A-1140

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Hong Kong3 sites

  • Queen Elizabeth Hospital

    Hong Kong, 999077

  • Queen Mary Hospital

    Hong Kong, 999077

  • Prince of Wales Hospital

    New Territories

Other trials in Hong Kong

United Kingdom2 sites

  • St Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A 7BE

  • The Christie NHS Foundation Trust, Department of Medical Oncology

    Manchester, M20 4BX

Other trials in United Kingdom

Singapore1 site

  • Tang Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

Official title: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Being tested
Zimberelimab, Domvanalimab, Pembrolizumab, Carboplatin, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZimberelimabDrug

    Also called GS-0122, AB122

    Administered intravenously

  • DomvanalimabDrug

    Also called GS-0154, AB154

    Administered intravenously

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Administered intravenously

  • CarboplatinDrug

    Administered intravenously

  • CisplatinDrug

    Administered intravenously

  • PaclitaxelDrug

    Administered intravenously

  • Nab-paclitaxelDrug

    Administered intravenously

  • PemetrexedDrug

    Administered intravenously

Study groups in NCT05502237
Study groupRoleWhat they receive
Zimberelimab (ZIM) +Domvanalimab (DOM) + ChemotherapyExperimentalParticipants will receive ZIM 360 mg + DOM 1200 mg (up to 35 doses) with chemotherapy every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin area under the concentration versus time curve (AUC)5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Receives: Drug: Zimberelimab; Drug: Domvanalimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed
Pembrolizumab (PEMBRO) + ChemotherapyActive comparatorParticipants will receive PEMBRO 200 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles. After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed
Zimberelimab (ZIM) + ChemotherapyExperimentalParticipants will receive ZIM 360 mg (up to 35 doses) with chemotherapy Q3W on Day 1 of each 21-day cycle. Choice of chemotherapy is dependent on histology. * Participants with nonsquamous histology will receive cisplatin 75 mg/m^2 or carboplatin AUC 5 + pemetrexed 500 mg/m^2 Q3W for first 4 cycles After the completion of the first 4 cycles, participants with nonsquamous histology may continue with maintenance pemetrexed 500 mg/m^2 Q3W until disease progression or intolerable toxicities. * Participants with squamous histology will receive carboplatin AUC 6 Q3W with paclitaxel 200 mg/m^2 Q3W or nab-paclitaxel 100 mg/m^2 weekly (QW) for first 4 cycles.
Receives: Drug: Zimberelimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants.

    OS is defined as the time from the date of randomization to the date of death from any cause.

    Measured: Up to 68 months

Secondary outcomes (6)

  1. Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    PFS is defined as the time from the date of randomization until disease progression (PD) or death from any cause, whichever comes first.

    Measured: Upt to 50 months

  2. Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

    ORR is defined as the proportion of participants who have achieved a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.

    Measured: Up to 50 Months

  3. Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1

    DOR is defined as the time from the first response (CR or PR), to the first documented PD or death from any cause, whichever comes first.

    Measured: Up to 50 Months

  4. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: First dose date up to 50 months plus 30 days

  5. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Measured: First dose date up to 50 months plus 30 days

  6. Time to First Symptom Deterioration in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score

    The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.

    Measured: Baseline, Up to 50 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start12 Oct 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,021 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502237
Sponsor's protocol ID
GS-US-626-6216
Other IDs
2022-000578-25
Acronym
STAR-121
Status last verified
Jan 2026
First submitted
12 Aug 2022
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zimberelimab, Domvanalimab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Gilead Sciences at 186 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in China, Spain, Japan, United States, Brazil and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Participants With Positive Programmed Cell Death-Ligand 1 (PD-L1) Expression (≥1%Tumor Cells) and in all Randomized Participants. (time frame: Up to 68 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05502237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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