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

Non-small Cell Lung Cancer Clinical Trial

— STAR-121  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502237
• Other study ID #: GS-US-626-6216
• Secondary ID: 2022-000578-25
• Status: Recruiting
• Phase: Phase 3
• Start date: October 12, 2022
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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.
• 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.

Key Exclusion Criteria:

• 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).
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Zimberelimab
Administered intravenously
• Domvanalimab
Administered intravenously
• Pembrolizumab
Administered intravenously
• Carboplatin
Administered intravenously
• Cisplatin
Administered intravenously
• Paclitaxel
Administered intravenously
• Nab-paclitaxel
Administered intravenously
• Pemetrexed
Administered intravenously

Locations

Country	Name	City	State
Argentina	Investigaciones CORI S.R.L.	Capital
Argentina	Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica	Cardoba
Argentina	Centro Medico Barrio Parque	Ciudad Autanoma Buenos Aires
Argentina	Sanatorio Allende	Cordoba
Argentina	Hospital Provincial del Centenario	Rosario
Argentina	Instituto Medico de la Fundacion Estudios Clinicos	Rosario
Argentina	Sanatorio Britanico de Rosario	Rosario
Argentina	Sanatorio Parque de Rosario	Rosario
Argentina	CAIPO - Centro para la Atención Integral del Paciente Oncológico	San Miguel de Tucumán
Argentina	Clínica Viedma	Viedma
Austria	Klinikum Klagenfurt am Woerthersee	Klagenfurt Am Woerthersee
Austria	Ordensklinikum Linz GmbH, Elisabethinen	Linz
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Krankenhaus Nord - Klinik Floridsdorf	Wien
Belgium	Algemeen Ziekenhuis Sint-Lucas	Aalst
Belgium	Grand Hopital de Charleroi asbl (GHdC)	Charleroi
Belgium	AZ Sint-Maarten	Mechelen
Belgium	CHU UCL Namur / Site Sainte Elisabeth	Namur
Brazil	Cenantron Centro Avançado de Tratamento Oncologico Ltda	Belo Horizonte
Brazil	Hospital Evangelico de Cachoeiro de Itapemirim	Cachoeiro De Itapemirim
Brazil	Fundacao Universidade De Caxias Do Sul - FUCS/RS	Caxias Do Sul
Brazil	Instituto do Câncer do Ceará - ICC	Fortaleza
Brazil	Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA	Ijui
Brazil	Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho	Jau
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre
Brazil	Hospital São Lucas da PUCRS	Porto Alegre
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Hospital Ana Nery Santa Cruz do Sul	Santa Cruz Do Sul
Brazil	Instituto Brasiliero de Controle do Cancer IBCC	Sao Paulo
Canada	Centre Integre de sante et de services sociaux de la Monteregie Centre	Greenfield Park
Canada	Moncton Hospital	Moncton
Canada	CISSS des Laurentides	Quebec
Canada	Centre de santé et services sociaux de Rimouski-Neigette	Rimouski
Canada	BC Cancer - Victoria	Victoria
Chile	Clinica Alemana de Santiago	Las Condes
Chile	Oncovida- Santiago	Providencia
Chile	Orlandioncologia	Providencia
Chile	Clinica Puerto Montt	Puerto Montt
Chile	Biocinetic	Santiago
Chile	James Lind Centro de Investigacion del Cancer	Temuco
Chile	Oncocentro APYS	Vina del Mar
China	West China Hospital Sichuan University	Chengdu
China	Deyang People's Hospital	Deyang
China	Shanghai Pulmonary Hospital	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang
France	Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris	Boulogne-Billancourt
France	CHU de Caen	Caen
France	Clinique Victor Hugo, Centre de Cancerologie de la Sarthe	Le Mans
France	Hopital Nord	Marseille
France	Institut de Cancer de Montpellier (ICM) - Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Institut de cancerologie de l'ouest (ICO)	Saint-Herblain
France	Hopital d'Instruction des Armees (HIA) Begin	Saint-Mandé
France	Centre Hospitalier de Saint-Quentin	Saint-Quentin
France	Institut de Cancerologie Strasbourg Europe (ICANS)	Strasbourg
France	Hôpital Foch	Suresnes
France	CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse	Toulon cedex
Germany	Augusta-Kranken-Anstalt gGmbh Klinik für Hämatologie Onkologie und Palliativmedizin	Bochum
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)	Essen
Germany	Universitätsklinikum Freiburg, Klinik für Innere Medizin I Hämatologie, Onkologie und Stammzelltransplantation	Freiburg
Germany	LungenClinic Grosshansdorf	Grosshansdorf
Germany	Krankenhaus Martha-Maria Halle Dölau	Halle
Germany	Asklepios Kliniken Hamburg	Hamburg
Germany	Katholisches Marienkrankenhaus gGmbH	Hamburg
Germany	Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie	Hemer
Germany	Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2	Karlsruhe
Germany	Klinikum Kassel	Kassel
Germany	Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik	Köln
Germany	Universitatsklinikum Schleswig-Holstein	Lubeck
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie	Munchen
Germany	Sana Klinikum Offenbach GmbH, Medizinische Klinik IV, Hämatologie und Internistische Onkologie	Offenbach
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	New Territories
Israel	Soroka University Medical Center, Itzchak Rager Blvd.	Beer Seva
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri	Nahariya
Israel	Rabin Medical Center	Petah Tiqva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera San Giuseppe Moscati	Avellino
Italy	IRCCS Fondazoine del Piemonte per l'Oncologia	Candiolo
Italy	Azienda Socio Sanitaria Territoriale di Cremona	Cremona
Italy	Ospedale Policlinico San Martino	Genova
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliero Universitaria di Modena	Modena
Italy	AORN Cardarelli	Naples
Italy	Azienda Ospedaliera dei Colli	Napoli
Italy	IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica	Pavia
Italy	Azienda Sanitaria Territoriale Pesaro e Urbino (AST)	Pesaro
Italy	Ospedale Guglielmo da Saliceto AUSL di Piacenza	Piacenza
Italy	Centro di Riferimento Oncologico	Pordenone
Italy	Regina Elena Institute for Cancer Research	Rome
Italy	ASST Bergamo Ovest- ospedale di Treviglio	Treviglio
Japan	National Cancer Center Hospital East	Chiba
Japan	National Hospital Organization Shikoku Cancer Center	Ehime
Japan	Kurume University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Hyogo Cancer Center	Hyogo
Japan	National Hospital Organization Himeji Medical Center	Hyogo
Japan	Kanazawa University Hospital	Ishikawa
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Sendai Kousei Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Kindai University Hospital	Osaka
Japan	National Hospital Organization Kinki Chuo Chest Medical Center	Osaka
Japan	Osaka Medical and Pharmaceutical University Hospital	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Saitama Medical University	Saitama
Korea, Republic of	SMG - SNU Boramae Medical Center	Dongjak-Gu
Korea, Republic of	Samsung Medical Center	Gangnam-Gu
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Chungbuk National University Hospital	Heungdeok-Gu
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Gachon University Gil Medical Center	Inchon
Korea, Republic of	Kosin University Gospel Hospital	Seo-gu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Saint Vincent's Hospital	Suwon
Korea, Republic of	Ajou University Hospital	Suwon-si
Mexico	Health Pharma Professional Research S.A. de C.V.	Mexico
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Mitras Centro
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Clinical Medical Research SC.	Orizaba Centro
Mexico	Clinica Integral Internacional de Oncologia S de RL de CV	Puebla
Mexico	FAICIC Clínical Research	Veracruz
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Ziekenhuis St Jansdal	Harderwijk
Netherlands	TweeSteden Ziekenhuis	Tilburg
Portugal	Hospital Prof. Doutor Fernando Fonseca	Amadora
Portugal	Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente	Lisboa
Portugal	Fundacao Champalimaud	Lisboa
Portugal	Instituto Português de Oncologia de Lisboa Francisco Gentil	Lisboa
Portugal	Hospital Beatriz Angelo. Hospital de Loures.	Lisbon
Portugal	Centro Hospitalar Universitario Sao Joao, EPE	Porto
Portugal	Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA	Senhora da Hora
Singapore	Raffles Hospital	Singapore
Singapore	Tang Tock Seng Hospital	Singapore
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i de Sant Pau	Barcelona
Spain	Hospital Parc Tauli	Barcelona
Spain	Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Doctor Josep Trueta	Girona
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital Universitario de Canarias	Las Palmas de G.C.
Spain	Clinica Universidad de Navarra	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Majadahonda
Spain	Hospital Sant Joan de Reus	Reus
Spain	Hospital Regional Universitario de Malaga	Rincon de la Victoria
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocio	Seville
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Vithas Valencia 9 de Octubre	Valencia
Spain	Instituto Valenciano De Oncologia (IVO)	Valencia
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	E-DA Hospital	Kaohsiung City
Taiwan	Chi Mei Hospital, Liouying	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation	Taoyuan City
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Trakya University Faculty of Medicine	Edirne
Turkey	Istanbul University Cerrahpasa Medical Faculty Hospital	Fatih
Turkey	Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Medipol Mega University Hospital	Istanbul
Turkey	Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi	Kaakaekmece
Turkey	Turgut Ozal Medical Faculty	Malatya
United Kingdom	Colchester General Hospital	Colchester
United Kingdom	St Bartholomew's Hospital, Barts Health NHS Trust	London
United Kingdom	University Hospital Southampton Nhs Foundation Trust	Southampton
United States	Arlington Cancer Center	Arlington	Texas
United States	US Oncology Investigational Products Center (IPC)	Arlington	Virginia
United States	Messino Cancer Centers	Asheville	North Carolina
United States	Peachtree Hematology Oncology Consultants	Atlanta	Georgia
United States	Texas Oncology - Austin	Austin	Texas
United States	Oncology and Hematology Associates of Southwest Virginia, Inc	Blacksburg	Virginia
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Texas Oncology	Dallas	Texas
United States	Hematology & Oncology Associates	Eugene	Oregon
United States	Palo Verde Hematology Oncology Ltd	Glendale	Arizona
United States	Lake City Cancer Care	Lake City	Florida
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	Illinois Cancer Care	Peoria	Illinois
United States	AHN Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	California Cancer Associates for Research and Excellence	San Marcos	California
United States	Texas Oncology	Santa Barbara	California
United States	Florida Cancer Specialists	Sarasota	Florida
United States	Texas Oncology- Denison	Sherman	Texas
United States	Moffitt Cancer Center	Tampa	Florida
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Arcus Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Portugal,  Singapore,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 31 months
Primary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause.	Up to 58 months
Secondary	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.	Up to 58 Months
Secondary	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.	Up to 58 Months
Secondary	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to 58 months plus 30 days
Secondary	Percentage of Participants Experiencing Clinical Laboratory Abnormalities		First dose date up to 58 months plus 30 days
Secondary	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	Baseline, Up to 58 Months

External Links

•   Gilead Clinical Trials Website