Non-Small Cell Lung CancerPhase 3NCT06758401
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.
A Phase 3 study testing Sigvotatug Vedotin and Pembrolizumab in people with Non-Small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 389 sites in 31 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
- What is being tested?
- Sigvotatug Vedotin and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 389 sitesin 31 countries
- Study dates
- 23 Jul 2025to 1 Mar 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
- 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 known AGAs including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved and available first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
- Participants with large cell neuroendocrine carcinoma are excluded.
- Must be an appropriate 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.
Who cannot join
- 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
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- 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. Up to 5 clinically asymptomatic brain metastases of longest diameter <1.0 cm are permitted without definitive surgery and/or radiotherapy.
- Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery (excluding peripherally inserted central catheter placement and implantable central venous port placement) within 3 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
- Participants with prior solid organ or bone marrow transplantation.
- Currently receiving a high-dose steroid (>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.
- Prior and concomitant therapy:
- Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
- Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
- (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.
- Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.
- Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received. This includes both curative and palliative radiotherapy.
- Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.
- Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
- History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.
- Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months
Trial locations and contacts
389 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
389 sites in 31 countries
United States84 sites, 83 recruiting
- Recruiting
University Hospitals Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
- Recruiting
SCL Health - Montana
Billings, Montana, 59101
- Recruiting
SCL Health - Montana
Billings, Montana, 59102
- Recruiting
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, 55337
- Terminated
Gabrail Cancer Center Research
Canton, Ohio, 44718
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
The University of Texas, MD Anderson Cancer Center - Woodlands
Conroe, Texas, 77384
- Recruiting
Minnesota Oncology Hematology PA
Coon Rapids, Minnesota, 55433
- Recruiting
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, 55435
- Recruiting
Minnesota Oncology Hematology PA
Edina, Minnesota, 55435
- Recruiting
Renovatio Clinical - El Paso
El Paso, Texas, 79915
- Recruiting
Endeavor Health
Elmhurst, Illinois, 60126
- Recruiting
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
- Recruiting
Southcoast Centers for Cancer Care
Fall River, Massachusetts, 02720
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
Fremont, Nebraska, 68025
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California, 92835
- Recruiting
Providence St. Jude Medical Center
Fullerton, California, 92835
- Recruiting
St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
Fullerton, California, 92835
- Recruiting
Intermountain Health Cancer Center Lutheran Hospital
Golden, Colorado, 80401
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
Grand Island, Nebraska, 68803
- Recruiting
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501
- Recruiting
Intermountain Health St. Mary's Regional Hospital
Grand Junction, Colorado, 81501
- Recruiting
Intermountain Health
Grand Junction, Colorado, 81505
- Recruiting
Corewell Health - Butterworth Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Corewell Health - Lemmen Holton Cancer Pavilion
Grand Rapids, Michigan, 49503
- Recruiting
Corewell Health - Research Specimen Processing Area
Grand Rapids, Michigan, 49503
- Recruiting
Corewell Health Investigational Drug Services
Grand Rapids, Michigan, 49503
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
- Recruiting
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
- Recruiting
ECU Health Medical Center
Greenville, North Carolina, 27834
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
- Recruiting
The University of Texas MD Anderson Cancer Center Diagnostic Imaging
Houston, Texas, 77030
- Recruiting
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030
- Recruiting
The University of Texas, MD Anderson Cancer Center- Interventional Radiology
Houston, Texas, 77030
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
The University of Texas MD Anderson Cancer Center Clinical Research Imaging
Houston, Texas, 77054
- Recruiting
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079
- Recruiting
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
- Recruiting
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39216
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
- Recruiting
Kearney Cancer Center
Kearney, Nebraska, 68845
- Recruiting
Community Clinical Trials
Kingwood, Texas, 77339
- Recruiting
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, 77573
- Recruiting
Saint Luke's East Hospital
Lee's Summit, Missouri, 64086
- Recruiting
Advocate Medical Group - Libertyville Oncology
Libertyville, Illinois, 60048
- Recruiting
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
- Recruiting
Minnesota Oncology Hematology PA
Maple Grove, Minnesota, 55369
- Recruiting
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
- Recruiting
Minnesota Oncology Hematology PA
Maplewood, Minnesota, 55109
- Recruiting
University Hospitals Seidman Cancer Center at UH Mentor Health Center
Mentor, Ohio, 44060
- Recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
- Recruiting
Endeavor Health
Naperville, Illinois, 60540
- Recruiting
Hope and Healing Cancer Services
New Lenox, Illinois, 60451
- Recruiting
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
- Recruiting
American Oncology Network Vista Oncology Division-West office
Olympia, Washington, 98502
- Recruiting
American Oncology Network Vista Oncology Division-East office
Olympia, Washington, 98506
- Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Methodist
Omaha, Nebraska, 68114
- Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
Omaha, Nebraska, 68124
- Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
- Recruiting
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio, 44122
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
- Recruiting
Saint Luke's South Hospital
Overland Park, Kansas, 66213
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
- Recruiting
BRCR Global
Plantation, Florida, 33322
- Recruiting
Maine Medical Center
Portland, Maine, 04102
- Recruiting
North Memorial Health Cancer Center
Robbinsdale, Minnesota, 55422
- Recruiting
Metro Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426
- Recruiting
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
- Recruiting
MaineHealth Cancer Care and Blood Disorders Scarborough
Scarborough, Maine, 04074
- Recruiting
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
- Recruiting
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, 77478
- Recruiting
Renovatio Clinical
The Woodlands, Texas, 77380
- Recruiting
Woodlands Radiology
The Woodlands, Texas, 77381
- Recruiting
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, 20422
- Recruiting
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401
- Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, 27893
- Recruiting
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
Woodbury, Minnesota, 55125
China31 sites, 31 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, 101149
- Recruiting
Jilin Province Tumor Hospital
Changchun, Jilin, 130000
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
- Recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Recruiting
Yunnan Province Cancer Hospital
Kunming, Yunnan, 650118
- Recruiting
LinYi Cancer Hospital
Linyi, Shandong, 276001
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
Wuhan Union Hospital Cancer Center
Wuhan, Hubei, 430048
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Brazil26 sites, 26 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
- Recruiting
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, 12916-542
- Not yet recruiting
Onco-Vida - Instituto Especializado De Oncologia
Brasília, Federal District, 70390-150
- Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
- Recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336232
- Recruiting
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, Ceará, 60430235
- Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000
- Not yet recruiting
Fundação Doutor Amaral Carvalho
Jaú, 17210-080
- Recruiting
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501-001
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
- Not yet recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Real Hospital de Beneficência Portuguesa de Pernambuco
Recife, Pernambuco, 52010-902
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo, 14051-140
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, 22031-011
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, 22271-110
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, 22281-100
- Recruiting
Instituto D'Or de Pesquisa e Ensino
Rio de Janeiro, 22451-040
- Recruiting
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
- Recruiting
Clinica Amo - Rio Vermelho
Salvador, Estado de Bahia, 41950- 640
- Recruiting
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090000
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01327-001
- Not yet recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
- Recruiting
Vencer Centro de Pesquisa LTDA
Teresina, Piauí, 64049-200
- Recruiting
Afecc Associacao Feminina Educacao Combate Cancer
Vitória, Espírito Santo, 29043-260
Germany20 sites, 20 recruiting
- Recruiting
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
- Recruiting
Charité Campus Virchow-Klinikum
Berlin, 13353
- Recruiting
Labor Berlin
Berlin, 13353
- Recruiting
Vivantes Humboldt Klinikum Apotheke Nord
Berlin, 13509
- Recruiting
Vivantes Hospital Spandau
Berlin, 13585
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, 09113
- Recruiting
Klinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, 09116
- Recruiting
Asklepios Klinik Gauting GmbH
Gauting, 82131
- Recruiting
UKGM Gießen/Marburg
Giessen, Hesse, 35392
- Recruiting
Johannes Apotheke Gröbenzell
Gröbenzell, Bavaria, 82194
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, 22927
- Recruiting
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, 06120
- Recruiting
Klinikum Kassel
Kassel, Hesse, 34125
- Recruiting
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, 56068
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
- Recruiting
Radiologie München
München, 81377
- Recruiting
ohO Research GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
- Recruiting
Klinikum Traunstein
Traunstein, Bavaria, 83278
- Recruiting
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Japan20 sites, 20 recruiting
- Recruiting
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 0708644
- Not yet recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
- Recruiting
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
- Recruiting
Kurume University Hospital
Kurume, Fukuoka, 830-0011
- Recruiting
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555
- Recruiting
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902
- Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1154
- Recruiting
Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
- Recruiting
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 9810914
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Not yet recruiting
Ehime University Hospital
Tōon, Ehime, 791-0295
- Recruiting
Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101
- Recruiting
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
- Not yet recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Argentina19 sites, 19 recruiting
- Recruiting
Centro de Oncología e Investigación de Buenos Aires
Berazategui, Buenos Aires, B1884BBF
- Recruiting
Centro de Investigaciones Medicas y Desarrollo LC
Buenos Aires, Cdad. Autónoma de Buenos Aires, C 1113
- Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
- Recruiting
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, C1122AAL
- Recruiting
Fundacion Medica de Rio Negro y Neuquen
Cipolletti, Río Negro Province, 8324
- Recruiting
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
- Not yet recruiting
Centro Urológico Profesor Bengió
Córdoba, 5000
- Recruiting
Sanatorio Privado de la Cañada
Córdoba, 5000
- Recruiting
Hospital Privado Universitario de Córdoba
Córdoba, 5016
- Recruiting
Centro Medico Privado CEMAIC
Córdoba, X5008AAC
- Recruiting
Centro Medico de Enfermedades Respiratorias -CEMER
Florida, Buenos Aires, B1602DQD
- Recruiting
Investigaciones Oncológicas C. Colón S.A
Mar del Plata, Buenos Aires, B7600FZD
- Not yet recruiting
Centro de Investigación Pergamino
Pergamino, Buenos Aires, B2700CPM
- Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
- Recruiting
Sanatorio Británico
Rosario, Santa Fe Province, S2000CVB
- Recruiting
Sanatorio Parque
Rosario, Santa Fe Province, S2000DSV
- Recruiting
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS
- Recruiting
Instituto San Marcos
San Juan, 5400
- Recruiting
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, 4600
Spain18 sites, 18 recruiting
- Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006
- Recruiting
Hospital Universitari Dexeus
Barcelona, Barcelona [barcelona], 08028
- Recruiting
Hospital Universitari Vall D Hebron
Barcelona, Barcelona/spain, 08035
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041
- Recruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (hereinafter, "VHIR")
Barcelona, 08035
- Recruiting
Fundación Privada Instituto de Investigación Oncológica de Vall Hebron (hereinafter, "VHIO"
Barcelona, 08035
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
- Recruiting
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
- Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], 08908
- Recruiting
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, 35016
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
- Recruiting
FutureMeds - Madrid
Madrid, 28003
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Quirón Málaga
Málaga, 29004
- Recruiting
Hospital Son Llàtzer
Palma, Illes Balears [islas Baleares], 07198
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Turkey (Türkiye)16 sites, 16 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi
Adana, 01140
- Recruiting
Ankara University Health Practice and Research Hospitals
Ankara, Turkey, 06230
- Recruiting
Gulhane Egitim Arastirma Hastanesi
Ankara, 06010
- Recruiting
Hacettepe Universite Hastaneleri
Ankara, 06230
- Recruiting
Memorial Ankara Hastanesi
Ankara, 06520
- Recruiting
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560
- Recruiting
Liv Hospital Ankara
Ankara, 06680
- Recruiting
Ankara Bilkent Şehir Hastanesi
Ankara, 06800
- Recruiting
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
- Recruiting
Dicle Üniversitesi
Diyarbakır, 21200
- Recruiting
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, 34214
- Recruiting
İ.A.Ü VM Medical Park Florya Hastanesi
Istanbul, İ̇stanbul, 34295
- Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, 34722
- Recruiting
Istanbul Universitesi Cerrahpasa
İstanbul - Fatih, 34098
- Recruiting
Ege Universitesi Hastanesi
Izmir, İ̇zmir, 35100
- Recruiting
İzmir Suat Seren Chest Disease Training & Research Hospital
Izmir, İ̇zmir, 35110
France14 sites, 14 recruiting
- Recruiting
Centre Hospitalier de Cholet
Cholet, PAYS de Loire, 49300
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Val-de-marne, 94010
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
- Recruiting
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-roussillon, 34070
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014
- Recruiting
Institut Curie
Paris, 75248
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33604
- Recruiting
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper, Brittany Region, 1757 - 29107
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-vilaine, 35033
- Recruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-atlantique, 44800
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-atlantique, 44805
- Recruiting
Centre Hospitalier intercommunal de Toulon La Seyne sur Hospital Sainte-Musse health establishment
Toulon, Provence-Alpes-Côte d'Azur Region, 83056
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-garonne, 31059
Chile12 sites, 12 recruiting
- Recruiting
Iceg Clinic
La Florida, Santiago Metropolitan, 8241479
- Recruiting
Fundación Arturo Lopéz Pérez
Providencia, Santiago Metropolitan, 750000
- Recruiting
FALP
Providencia, Santiago Metropolitan, 7500836
- Recruiting
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, 7500966
- Recruiting
Profar
Providencia, Santiago Metropolitan, 7501010
- Recruiting
FALP
Providencia, Santiago, RM, 7500921
- Recruiting
Clínica Vespucio
Santiago, Santiago Metropolitan, 8241479
- Recruiting
Instituto Nacional del Cancer
Santiago, Santiago Metropolitan, 8380455
- Recruiting
Sociedad Oncovida SA
Santiago, Santiago Metropolitan, 8380456
- Recruiting
Clínica Alemana Valdivia
Valdivia, Los Ríos Region, 5090000
- Recruiting
Oncocentro Valdivia
Valdivia, Los Ríos Region, 5690000
- Recruiting
Oncocentro Apys
Viña del Mar, Valparaiso, 2520598
Italy12 sites, 12 recruiting
- Recruiting
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
- Recruiting
Policlinico "G. Rodolico"
Catania, Sicily, 95123
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
- Recruiting
Humanitas Istituto Clinico Catanese
Misterbianco, Catania, 95045
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Campania, 80131
- Recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
- Recruiting
Azienda Sanitaria Territoriale Pesaro e Urbino (AST PU)
Pesaro (PU), Pesaro AND Urbino, 61121
- Recruiting
IRCCS Istituto Nazionale dei Tumori Regina Elena
Roma, ROME, 00144
- Recruiting
Ospedale Isola Tiberina - Gemelli Isola
Rome, ROMA, 00186
South Korea10 sites, 10 recruiting
- Recruiting
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, 49241
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-kwangyǒkshi, 41404
- Recruiting
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-kwangyǒkshi, 48108
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo, 58128
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
- Recruiting
Boramae Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 07061
- Recruiting
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308
- Recruiting
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, 16247
- Recruiting
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
Australia9 sites, 9 recruiting
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
- Recruiting
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
- Recruiting
Townsville University Hospital
Douglas, Queensland, 4814
- Recruiting
Gympie Hospital
Gympie, Queensland, 4570
- Recruiting
Nambour General Hospital
Nambour, Queensland, 4560
- Recruiting
Macquarie University
North Ryde, New South Wales, 2109
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
- Recruiting
Campbelltown Hospital
Sydney, New South Wales, 2560
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Romania9 sites, 9 recruiting
- Recruiting
SC Memorial Healthcare International SRL
Bucharest, Bucharest, 013812
- Recruiting
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, 022338
- Not yet recruiting
Sc Mnt Healthcare Europe Srl
Bucharest, Bucharest, 077190
- Recruiting
SC Medisprof SRL
Cluj-Napoca, Cluj, 400641
- Recruiting
SC Oncolab SRL
Craiova, Dolj, 200385
- Not yet recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
- Recruiting
Ovidius Clinical Hospital OCH
Ovidiu, Constanța County, 905900
- Not yet recruiting
S C Oncocenter Oncologie Clinica S R L
Timișoara, Timiș County, 300166
United Kingdom9 sites, 9 recruiting
- Not yet recruiting
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD
- Recruiting
St Bartholomew's Hospital
London, London, CITY of, EC1A 7BE
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Not yet recruiting
Mount Vernon Hospital
Northwood, Hillingdon, HA6 2RN
- Not yet recruiting
Royal Berkshire Hospital
Reading, RG1 5AN
- Not yet recruiting
Weston Park Hospital
Sheffield, England, S10 2SJ
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
- Not yet recruiting
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
- Recruiting
Royal Cornwall Hospitals NHS Trust
Truro, Carnwall, TR1 3LJ
Greece8 sites, 8 recruiting
- Recruiting
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27
- Recruiting
Metropolitan General Hospital
Athens, Attikí, 155 62
- Recruiting
Metropolitan Hospital
Athens, Attikí, 185 47
- Recruiting
Errikos Dunant Hospital Center
Athens, 115 26
- Recruiting
University General Hospital of Larissa, Urology Department
Larissa, 41110
- Recruiting
Hygeia Hospital
Marousi, Attikí, 151 23
- Recruiting
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01
- Recruiting
Agios Loukas Clinic
Thessaloniki, 552 36
India8 sites, 8 recruiting
- Recruiting
Spandana Oncology Centre (SOC)
Bengaluru, Karnataka, 560069
- Not yet recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
- Recruiting
Dr B. L. Kapur Memorial Hospital
New Delhi, National Capital Territory of Delhi, 110005
- Recruiting
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075
- Recruiting
Fortis Hospital
New Delhi, National Capital Territory of Delhi, 110088
- Recruiting
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
- Recruiting
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, 401107
Taiwan8 sites, 8 recruiting
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 833401
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407
- Not yet recruiting
Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Not yet recruiting
National Taiwan University Cancer Center (NTUCC)
Taipei City, Taipei, 106
Poland7 sites, 7 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Gliwice, 44-102
- Recruiting
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, 90-302
- Recruiting
Instytut Genetyki i Immunologii GENIM
Lublin, Lublin Voivodeship, 20-609
- Recruiting
Med-Polonia Sp. z o. o.
Poznan, Greater Poland Voivodeship, 60-693
- Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Poznan, 60-569
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-781
Bulgaria6 sites, 6 recruiting
- Recruiting
Complex Oncology Center - Burgas
Burgas, 8000
- Recruiting
MBAL Uni Hospital
Panagyurishte, Pazardzhik, 4500
- Not yet recruiting
Medical Center Futuremeds
Plovdiv, 4000
- Recruiting
MHAT for Women's Health Nadezhda
Sofia, 1330
- Recruiting
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, 1407
- Recruiting
University Specialized Hospital for Active Treatment of Oncology EAD
Sofia, 1756
Slovakia6 sites, 6 recruiting
- Recruiting
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
Bratislava, Bratislava Region, 821 01
- Recruiting
Nemocnica AGEL Komarno
Komárno, Nitra Region, 945 05
- Recruiting
Vychodoslovensky Onkologicky Ustav a.s.
Košice, Košice Region, 040 01
- Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 94034
- Recruiting
POKO Poprad s.r.o.
Poprad, 058 01
- Recruiting
Fakultna nemocnica Trnava
Trnava, Trnava Region, 917 02
Belgium5 sites, 5 recruiting
- Recruiting
Algemeen Ziekenhuis klina
Brasschaat, 2930
- Recruiting
UZ Brussel
Brussels, Bruxelles-capitale, Région de, 1090
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
- Recruiting
AZ Sint-Maarten
Mechelen, Antwerpen, 2800
Czechia5 sites, 5 recruiting
- Recruiting
Krajska nemocnice Liberec, a.s.
Liberec1, 460 01
- Recruiting
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
- Recruiting
Fakultni Thomayerova nemocnice
Prague, Praha 4, 140 59
- Recruiting
Fakultni Nemocnice Motol a Homolka
Prague, 150 00
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, 4818 CK
- Recruiting
Ziekenhuis St. Jansdal
Harderwijk, Gelderland, 3844 DG
- Not yet recruiting
Frisius Medisch Centrum
Leeuwarden, Provincie Friesland, 8934 AD
- Recruiting
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ
- Recruiting
Isala, locatie Zwolle
Zwolle, Overijssel, 8025 AB
Austria4 sites, 4 recruiting
- Recruiting
Medizinische Universität Graz
Graz, 8036
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
- Recruiting
Medizinische Universität Wien
Vienna, 1090
- Recruiting
Klinik Floridsdorf
Vienna, 1210
Canada4 sites, 4 recruiting
- Recruiting
BC Cancer Abbotsford
Abbotsford British Columbia, British Columbia, V2S 0C2
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
- Recruiting
Centre de Services Ambulatoire de St-Jerome
Saint-Jérôme, Quebec, J7Y 0L1
- Recruiting
Unité de Recherche Clinique du CISSS des Laurentides
Saint-Jérôme, Quebec, J7Z 2V4
Hungary4 sites, 4 recruiting
- Not yet recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582
- Recruiting
Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, Bekes County, 5700
- Not yet recruiting
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000
- Not yet recruiting
Komárom-Esztergom Vármegyei Szent Borbála Kórház
Tatabánya, 2800
Mexico4 sites, 4 recruiting
- Recruiting
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, Jalisco, 44340
- Not yet recruiting
Instituto Nacional de Cancerologia
Mexico City, 14080
- Recruiting
Clinica Integral Internacional de Oncología
Puebla City, 72530
- Not yet recruiting
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz de Ignacio de LA Llave, Veracruz, 91900
Israel2 sites, 2 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
- Recruiting
Clalit Health Services through Rabin Medical Center
Petah Tikva, 4941492
Saudi Arabia2 sites, 2 recruiting
- Not yet recruiting
King Saud University Medical City
Riyadh, Riyadh Region, 11472
- Not yet recruiting
King Faisal Specialist Hospital and Research Center
Riyadh, 11211
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital Bern
Bern, Canton of Bern, 3010
- Recruiting
UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
- Being tested
- Sigvotatug Vedotin, Pembrolizumab
- Keywords
- Lung Cancer, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigvotatug VedotinDrug
MMAE-Antibody Drug Conjugate targeting Integrin Beta-6
PembrolizumabDrug
Anti-PD-(L)1
| Study group | Role | What they receive |
|---|---|---|
| Sigvotatug Vedotin with Pembrolizumab | Experimental | Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion. Receives: Drug: Sigvotatug Vedotin; Drug: Pembrolizumab |
| Pembrolizumab Monotherapy | Active comparator | Participants will receive pembrolizumab, administered as an IV infusion. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival defined as the duration from enrollment to death.
Measured: 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.
Measured: From Baseline to to date of first documentation of progression OR death (Approximately 2 years).
Secondary outcomes (13)
Progression Free Survival as assessed by Investigator
Progression Free Survival (PFS) is defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurs first.
Measured: From Baseline to date of first progression or death (Approximately 4 years).
Objective Response Rate as assessed by BICR
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
Measured: From Baseline to to the date of progression OR death (approximately to 4 years).
Objective Response Rate as assessed by Investigator
Defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Measured: From Baseline to to the date of progression OR death (approximately to 4 years).
Duration of Response as assessed by BICR
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: 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
Defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Measured: From the date of the first objective response to the date of disease progression or death (approximately to 4 years).
Number of participants with adverse events (AEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: From Baseline to end of treatment (up to 4 years).
Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab.
Measured: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of ac-MMAE in plasma: Plasma predose concentration (Cpredose)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab.
Measured: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of unconjugated monomethyl auristatin E (MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab.
Measured: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of MMAE in plasma: Plasma predose concentration (Cpredose)
To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab.
Measured: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
Number of participants with antidrug antibodies (ADAs)
To characterize the immunogenicity of sigvotatug vedotin when administered in combination with pembrolizumab.
Measured: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
Time to response (TTR) using RECIST v1.1 as assessed by BICR
Defined as the time from the date of randomization to the date of first documentation of objective response (CR or PR that is subsequently confirmed) per RECIST v1.1 by BICR.
Measured: The time from the date of randomization to the date of first documentation of objective response.
TTR using RECIST v1.1 as assessed by investigator
Defined as the time from the date of randomization to the date of first documentation of objective response (CR or PR that is subsequently confirmed) per RECIST v1.1 by investigator assessment.
Measured: The time from the date of randomization to the date of first documentation of objective response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start23 Jul 2025
- Primary completion5 Sep 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758401
- Sponsor's protocol ID
- C5751003
- Other IDs
- 2024-517968-36-00
- Status last verified
- Sep 2026
- First submitted
- 26 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41388832
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06758401
- Acronym / sponsor ID
- C5751003
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
- Keywords
- Lung Cancer, Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 5 Sep 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigvotatug Vedotin with Pembrolizumab | Experimental | Drug: Sigvotatug Vedotin, Drug: PembrolizumabParticipants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion. |
| Pembrolizumab Monotherapy | Active comparator | Drug: PembrolizumabParticipants will receive pembrolizumab, administered as an IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet the following criteria:
- 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.
Key exclusion criteria (27 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigvotatug VedotinMMAE-Antibody Drug Conjugate targeting Integrin Beta-6 | Drug | Sigvotatug Vedotin with Pembrolizumab |
| PembrolizumabAnti-PD-(L)1 | Drug | Pembrolizumab Monotherapy, Sigvotatug Vedotin with Pembrolizumab |
Primary outcome
Overall Survival
Time frame: Baseline to date of death from any cause (Approximately 2 years).
Overall survival defined as the duration from enrollment to death.
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Time frame: From Baseline to to date of first documentation of progression OR death (Approximately 2 years).
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.
13 secondary outcomes
Progression Free Survival as assessed by Investigator
Time frame: From Baseline to date of first progression or death (Approximately 4 years).
Objective Response Rate as assessed by BICR
Time frame: From Baseline to to the date of progression OR death (approximately to 4 years).
Objective Response Rate as assessed by Investigator
Time frame: From Baseline to to the date of progression OR death (approximately to 4 years).
Duration of Response as assessed by BICR
Time frame: 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
Time frame: From the date of the first objective response to the date of disease progression or death (approximately to 4 years).
Number of participants with adverse events (AEs)
Time frame: From Baseline to end of treatment (up to 4 years).
Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
Time frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of ac-MMAE in plasma: Plasma predose concentration (Cpredose)
Time frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of unconjugated monomethyl auristatin E (MMAE) in plasma: Plasma concentration at end of infusion (CEOI)
Time frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
PK of MMAE in plasma: Plasma predose concentration (Cpredose)
Time frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
Number of participants with antidrug antibodies (ADAs)
Time frame: Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1.
Time to response (TTR) using RECIST v1.1 as assessed by BICR
Time frame: The time from the date of randomization to the date of first documentation of objective response.
TTR using RECIST v1.1 as assessed by investigator
Time frame: The time from the date of randomization to the date of first documentation of objective response.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 41388832Reck 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
389 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sigvotatug Vedotin and Pembrolizumab in people with Non-Small Cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 389 sites in 31 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 8 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 389 sites in United States, China, Brazil, Germany, Japan and 26 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?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Baseline to date of death from any cause (Approximately 2 years).). The study lists 2 primary outcomes in all. 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 NCT06758401, which also lists 1 linked publication.
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 25 Sep 2026.