This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
Be6A Lung-02
AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)
2 other identifiers
interventional
714
29 countries
326
Brief Summary
The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control. The study is seeking for participants who:
- Are confirmed to have NSCLC (Stage 3 or 4).
- Have PD-L1 levels in more than 50% of the cancer cells. All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab. Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Jul 2025
326 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
April 20, 2026
April 1, 2026
3.1 years
December 26, 2024
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival defined as the duration from enrollment to death.
Baseline to date of death from any cause (Approximately 2 years)
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
From Baseline to to date of first documentation of progression OR death (Approximately 2 year)
Secondary Outcomes (11)
Progression Free Survival as assessed by Investigator
From Baseline to date of first progression or death (Approximately 4 Years)
Objective Response Rate as assessed by BICR
From Baseline to to the date of progression OR death (approximately to 4 years)
Objective Response Rate as assessed by Investigator
From Baseline to to the date of progression OR death (approximately to 4 years)
Duration of Response as assessed by BICR
From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
Duration of Response as assessed by Investigator
From the date of the first objective response to the date of disease progression or death (approximately to 4 years)
- +6 more secondary outcomes
Study Arms (2)
Sigvotatug Vedotin with Pembrolizumab
EXPERIMENTALParticipants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
Pembrolizumab Monotherapy
ACTIVE COMPARATORParticipants will receive pembrolizumab, administered as an IV infusion.
Interventions
MMAE-Antibody Drug Conjugate targeting Integrin Beta-6
Eligibility Criteria
You may qualify if:
- Participants must meet the following criteria:
- Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).
- Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.
- Large cell neuroendocrine carcinoma is excluded.
- Candidate for treatment with pembrolizumab monotherapy per local guidelines.
- Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing
- Measurable disease based on RECIST v1.1 per investigator.
- Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.
You may not qualify if:
- Life expectancy of \<3 months in the opinion of the investigator.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
- Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.
- Participants with any of the following respiratory conditions:
- Evidence of noninfectious or drug-induced ILD or pneumonitis
- Known DLCO (adjusted for hemoglobin) \<50% predicted.
- Grade ≥3 pulmonary disease unrelated to underlying malignancy
- Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \<0.5 cm are permitted.
- Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.
- Receipt of a live vaccine within 30 days prior to first dose of study intervention.
- Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.
- Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg/kg prednisone or equivalent per day) for \>2 weeks, or required treatment with systemic immunosuppressive therapy.
- History of autoimmune disease that has required systemic treatment in the past 2 years
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (329)
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California, 92835, United States
Providence St. Jude Medical Center
Fullerton, California, 92835, United States
St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
Fullerton, California, 92835, United States
Intermountain Health Cancer Center Lutheran Hospital
Golden, Colorado, 80401, United States
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501, United States
Intermountain Health St. Mary's Regional Hospital
Grand Junction, Colorado, 81501, United States
Intermountain Health
Grand Junction, Colorado, 81505, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
BRCR Global
Plantation, Florida, 33322, United States
Endeavor Health
Elmhurst, Illinois, 60126, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Endeavor Health
Naperville, Illinois, 60540, United States
Hope and Healing Cancer Services
New Lenox, Illinois, 60451, United States
Maine Medical Center
Portland, Maine, 04102, United States
MaineHealth Cancer Care - Scarborough
Scarborough, Maine, 04074, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology PA
Coon Rapids, Minnesota, 55433, United States
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology PA
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology PA
Maple Grove, Minnesota, 55369, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology PA
Maplewood, Minnesota, 55109, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Health Cancer Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
Woodbury, Minnesota, 55125, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39216, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
Fremont, Nebraska, 68025, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
Grand Island, Nebraska, 68803, United States
Cancer Partners of Nebraska - April Sampson Cancer Center
Lincoln, Nebraska, 68516, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Methodist
Omaha, Nebraska, 68114, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
Omaha, Nebraska, 68124, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Carolina Cancer Research Center
Wilson, North Carolina, 27893, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The University of Texas, MD Anderson Cancer Center - Woodlands
Conroe, Texas, 77384, United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915, United States
The University of Texas MD Anderson Cancer Center Diagnostic Imaging
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030, United States
The University of Texas, MD Anderson Cancer Center- Interventional Radiology
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center Clinical Research Imaging
Houston, Texas, 77054, United States
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079, United States
Community Clinical Trials
Kingwood, Texas, 77339, United States
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, 77573, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, 77478, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
Woodlands Radiology
The Woodlands, Texas, 77381, United States
American Oncology Network Vista Oncology Division-West office
Olympia, Washington, 98502, United States
American Oncology Network Vista Oncology Division-East office
Olympia, Washington, 98506, United States
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
Centro de Investigación Pergamino
Pergamino, Buenos Aires, B2700CPM, Argentina
Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, Cdad. Autónoma de Buenos Aires, C 1113, Argentina
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, 4600, Argentina
Fundacion Medica de Rio Negro y Neuquen
Cipolletti, Río Negro Province, 8324, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio Británico
Rosario, Santa Fe Province, S2000CVB, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, S2000DSV, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
Centro Oncologico Korben
Buenos Aires, 1426, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, C1122AAL, Argentina
Centro Urológico Profesor Bengió
Córdoba, 5000, Argentina
Sanatorio Privado de la Cañada
Córdoba, 5000, Argentina
Hospital Privado Universitario de Córdoba
Córdoba, 5016, Argentina
Centro Medico Privado CEMAIC
Córdoba, X5008AAC, Argentina
Instituto San Marcos
San Juan, 5400, Argentina
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450, Australia
Macquarie University
North Ryde, New South Wales, 2109, Australia
Campbelltown Hospital
Sydney, New South Wales, 2560, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Townsville University Hospital
Douglas, Queensland, 4814, Australia
Gympie Hospital
Gympie, Queensland, 4570, Australia
Nambour General Hospital
Nambour, Queensland, 4560, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
AZ Sint-Maarten
Mechelen, Antwerpen, 2800, Belgium
UZ Brussel
Brussels, Bruxelles-capitale, Région de, 1090, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060, Belgium
Algemeen Ziekenhuis klina
Brasschaat, 2930, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336232, Brazil
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, Ceará, 60430235, Brazil
Afecc Associacao Feminina Educacao Combate Cancer
Vitória, Espírito Santo, 29043-260, Brazil
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, 41253-190, Brazil
Clinica Amo - Rio Vermelho
Salvador, Estado de Bahia, 41950- 640, Brazil
Onco-Vida - Instituto Especializado De Oncologia
Brasília, Federal District, 70390-150, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Real Hospital Portugues
Recife, Pernambuco, 52010-075, Brazil
Vencer Centro de Pesquisa LTDA
Teresina, Piauí, 64049-200, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo, 14051-140, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01327-001, Brazil
Fundação Doutor Amaral Carvalho
Jaú, 17210-080, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
MBAL Uni Hospital
Panagyurishte, Pazardzhik, 4500, Bulgaria
Complex Oncology Center - Burgas
Burgas, 8000, Bulgaria
Medical Center Futuremeds
Plovdiv, 4000, Bulgaria
MHAT for Women's Health Nadezhda
Sofia, 1330, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407, Bulgaria
University Specialized Hospital for Active Treatment of Oncology EAD
Sofia, 1756, Bulgaria
BC Cancer Abbotsford
Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4, Canada
Centre de Services Ambulatoire de St-Jerome
Saint-Jérôme, Quebec, J7Y 0L1, Canada
Unité de Recherche Clinique du CISSS des Laurentides
Saint-Jérôme, Quebec, J7Z 2V4, Canada
Clínica Alemana Valdivia
Valdivia, Los Ríos Region, 5090000, Chile
Oncocentro Valdivia
Valdivia, Los Ríos Region, 5690000, Chile
Iceg Clinic
La Florida, Santiago Metropolitan, 8241479, Chile
Fundación Arturo Lopéz Pérez
Providencia, Santiago Metropolitan, 750000, Chile
FALP
Providencia, Santiago Metropolitan, 7500836, Chile
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, 7500966, Chile
Profar
Providencia, Santiago Metropolitan, 7501010, Chile
FALP
Santiago, Santiago Metropolitan, 7500921, Chile
Clínica Vespucio
Santiago, Santiago Metropolitan, 8241479, Chile
Instituto Nacional del Cancer
Santiago, Santiago Metropolitan, 8380455, Chile
Sociedad Oncovida SA
Santiago, Santiago Metropolitan, 8380456, Chile
Oncocentro Apys
Viña del Mar, Valparaiso, 2520598, Chile
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, 101149, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital Cancer Center
Wuhan, Hubei, 430048, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200, China
Jilin Province Tumor Hospital
Changchun, Jilin, 130000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
LinYi Cancer Hospital
Linyi, Shandong, 276001, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Sichuan Cancer hospital
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Yunnan Province Cancer Hospital
Kunming, Yunnan, 650118, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Fakultni Thomayerova nemocnice
Prague, Praha 4, 140 59, Czechia
Krajska nemocnice Liberec, a.s.
Liberec1, 460 01, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Motol a Homolka
Prague, 150 00, Czechia
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33604, France
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper, Finistère, 29107, France
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-garonne, 31059, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-vilaine, 35033, France
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-roussillon, 34070, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-atlantique, 44800, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-atlantique, 44805, France
Centre Hospitalier de Cholet
Cholet, PAYS de Loire, 49300, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, Provence-Alpes-Côte d'Azur Region, 83100, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Val-de-marne, 94010, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014, France
Institut Curie
Paris, 75248, France
Johannes Apotheke Gröbenzell
Gröbenzell, Bavaria, 82194, Germany
Klinikum Traunstein
Traunstein, Bavaria, 83278, Germany
UKGM Gießen/Marburg
Giessen, Hesse, 35392, Germany
Klinikum Kassel
Kassel, Hesse, 34125, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, 56068, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09113, Germany
Klinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, 09116, Germany
ohO Research GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Labor Berlin
Berlin, 13353, Germany
Vivantes Humboldt Klinikum Apotheke Nord
Berlin, 13509, Germany
Vivantes Hospital Spandau
Berlin, 13585, Germany
Asklepios Klinik Gauting GmbH
Gauting, 82131, Germany
LungenClinic Grosshansdorf
Großhansdorf, 22927, Germany
Radiologie München
München, 81377, Germany
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27, Greece
Metropolitan General Hospital
Athens, Attikí, 155 62, Greece
Metropolitan Hospital
Athens, Attikí, 185 47, Greece
Hygeia Hospital
Marousi, Attikí, 151 23, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01, Greece
Errikos Dunant Hospital Center
Athens, 115 26, Greece
University General Hospital of Larissa, Urology Department
Larissa, 41110, Greece
Agios Loukas Clinic
Thessaloniki, 552 36, Greece
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582, Hungary
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000, Hungary
Komárom-Esztergom Vármegyei Szent Borbála Kórház
Tatabánya, 2800, Hungary
Spandana Oncology Centre (SOC)
Bengaluru, Karnataka, 560069, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, 401107, India
Dr B. L. Kapur Memorial Hospital
New Delhi, National Capital Territory of Delhi, 110005, India
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075, India
Fortis Hospital
New Delhi, National Capital Territory of Delhi, 110088, India
AIG Hospitals
Hyderabad, Telangana, 500032, India
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102, Israel
Clalit Health Services through Rabin Medical Center
Petah Tikva, 4941492, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043, Italy
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144, Italy
Ospedale Isola Tiberina - Gemelli Isola
Rome, ROMA, 00186, Italy
Policlinico "G. Rodolico"
Catania, Sicily, 95123, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 0708644, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 9810914, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1154, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Clinica Integral Internacional de Oncología
Puebla City, 72530, Mexico
Ziekenhuis St. Jansdal
Harderwijk, Gelderland, 3844 DG, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, 4818 CK, Netherlands
Isala, locatie Zwolle
Zwolle, Overijssel, 8025 AB, Netherlands
Frisius Medisch Centrum
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ, Netherlands
Med-Polonia Sp. z o. o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Instytut Genetyki i Immunologii GENIM
Lublin, Lublin Voivodeship, 20-609, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-781, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Gliwice, 44-102, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Poznan, 60-569, Poland
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, 90-302, Poland
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, 022338, Romania
SC Medisprof SRL
Cluj-Napoca, Cluj, 400641, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280, Romania
Ovidius Clinical Hospital OCH
Ovidiu, Constanța County, 905900, Romania
S C Oncocenter Oncologie Clinica S R L
Timișoara, Timiș County, 300166, Romania
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
Bratislava, Bratislava Region, 821 01, Slovakia
Vychodoslovensky Onkologicky Ustav a.s.
Košice, Košice Region, 040 01, Slovakia
Nemocnica AGEL Komarno
Komárno, Nitra Region, 945 05, Slovakia
Fakultna nemocnica Trnava
Trnava, Trnava Region, 917 02, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 94034, Slovakia
POKO Poprad s.r.o.
Poprad, 058 01, Slovakia
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo, 58128, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, 49241, South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-kwangyǒkshi, 48108, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Boramae Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 07061, South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-kwangyǒkshi, 41404, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitari Dexeus
Barcelona, Barcelona [barcelona], 08028, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041, Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Son Llàtzer
Palma, Illes Balears [islas Baleares], 07198, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (hereinafter, "VHIR")
Barcelona, 08035, Spain
Fundación Privada Instituto de Investigación Oncológica de Vall Hebron (hereinafter, "VHIO"
Barcelona, 08035, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Quirón Málaga
Málaga, 29004, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Inselspital Bern
Bern, Canton of Bern, 3010, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657, Taiwan
National Taiwan University Cancer Center (NTUCC)
Taipei City, Taipei, 106, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 833401, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, 34214, Turkey (Türkiye)
İ.A.Ü VM Medical Park Florya Hastanesi
Istanbul, İ̇stanbul, 34295, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, 34722, Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, Turkey, 06230, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi
Adana, 01140, Turkey (Türkiye)
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21200, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa
İstanbul - Fatih, 34098, Turkey (Türkiye)
Royal Cornwall Hospitals NHS Trust
Truro, Carnwall, TR1 3LJ, United Kingdom
Weston Park Hospital
Sheffield, England, S10 2SJ, United Kingdom
Mount Vernon Hospital
Northwood, Hillingdon, HA6 2RN, United Kingdom
St Bartholomew's Hospital
London, London, CITY of, EC1A 7BE, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (1)
Reck M, Lu S, O'Byrne KJ, Barrios C, Pavlov D, Tay F, Negrao MV. Frontline sigvotatug vedotin plus pembrolizumab vs pembrolizumab for non-small cell lung cancer with PD-L1 tumor proportion score >/=50%: phase III study design. Future Oncol. 2025 Dec;21(30):3891-3901. doi: 10.1080/14796694.2025.2596228. Epub 2025 Dec 13.
PMID: 41388832DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2024
First Posted
January 3, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
September 5, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.