AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
  • 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

    Recruiting
  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Terminated
  • 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

    Recruiting

Other trials in United States

China31 sites, 31 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

    Recruiting

Other trials in China

Brazil26 sites, 26 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

    Recruiting
  • Onco-Vida - Instituto Especializado De Oncologia

    Brasília, Federal District, 70390-150

    Not yet 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

    Recruiting
  • Fundação Doutor Amaral Carvalho

    Jaú, 17210-080

    Not yet 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

    Recruiting
  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560032

    Not yet 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

    Recruiting
  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

    Not yet recruiting
  • Vencer Centro de Pesquisa LTDA

    Teresina, Piauí, 64049-200

    Recruiting
  • Afecc Associacao Feminina Educacao Combate Cancer

    Vitória, Espírito Santo, 29043-260

    Recruiting

Other trials in Brazil

Germany20 sites, 20 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

    Recruiting

Other trials in Germany

Japan20 sites, 20 recruiting
  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 0708644

    Recruiting
  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

    Not yet 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

    Recruiting
  • Ehime University Hospital

    Tōon, Ehime, 791-0295

    Not yet recruiting
  • Mie Chuo Medical Center

    Tsu, Mie-ken, 514-1101

    Recruiting
  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

    Recruiting
  • Kanagawa cancer center

    Yokohama, Kanagawa, 2418515

    Not yet recruiting

Other trials in Japan

Argentina19 sites, 19 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

    Recruiting
  • Centro Urológico Profesor Bengió

    Córdoba, 5000

    Not yet 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

    Recruiting
  • Centro de Investigación Pergamino

    Pergamino, Buenos Aires, B2700CPM

    Not yet 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

    Recruiting

Other trials in Argentina

Spain18 sites, 18 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

    Recruiting

Other trials in Spain

Turkey (Türkiye)16 sites, 16 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

    Recruiting

Other trials in Turkey (Türkiye)

France14 sites, 14 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

    Recruiting

Other trials in France

Chile12 sites, 12 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

    Recruiting

Other trials in Chile

Italy12 sites, 12 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

    Recruiting

Other trials in Italy

South Korea10 sites, 10 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

    Recruiting

Other trials in South Korea

Australia9 sites, 9 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

    Recruiting

Other trials in Australia

Romania9 sites, 9 recruiting
  • SC Memorial Healthcare International SRL

    Bucharest, Bucharest, 013812

    Recruiting
  • Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

    Bucharest, Bucharest, 022338

    Recruiting
  • Sc Mnt Healthcare Europe Srl

    Bucharest, Bucharest, 077190

    Not yet recruiting
  • SC Medisprof SRL

    Cluj-Napoca, Cluj, 400641

    Recruiting
  • SC Oncolab SRL

    Craiova, Dolj, 200385

    Recruiting
  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

    Not yet recruiting
  • SC Radiotherapy Center Cluj SRL

    Florești, Cluj, 407280

    Recruiting
  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța County, 905900

    Recruiting
  • S C Oncocenter Oncologie Clinica S R L

    Timișoara, Timiș County, 300166

    Not yet recruiting

Other trials in Romania

United Kingdom9 sites, 9 recruiting
  • Ipswich Hospital

    Ipswich, Suffolk, IP4 5PD

    Not yet recruiting
  • St Bartholomew's Hospital

    London, London, CITY of, EC1A 7BE

    Recruiting
  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    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

    Not yet recruiting
  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

    Recruiting
  • Musgrove Park Hospital

    Taunton, Somerset, TA1 5DA

    Not yet recruiting
  • Royal Cornwall Hospitals NHS Trust

    Truro, Carnwall, TR1 3LJ

    Recruiting

Other trials in United Kingdom

Greece8 sites, 8 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

    Recruiting

Other trials in Greece

India8 sites, 8 recruiting
  • Spandana Oncology Centre (SOC)

    Bengaluru, Karnataka, 560069

    Recruiting
  • AIG Hospitals

    Hyderabad, Telangana, 500032

    Not yet 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

    Recruiting

Other trials in India

Taiwan8 sites, 8 recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Not yet recruiting
  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung City, 833401

    Recruiting
  • Taichung Veterans General Hospital

    Taichung, 407

    Not yet recruiting
  • Chi Mei Hospital - Liouying Branch

    Tainan, Tainan, 73657

    Not yet recruiting
  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting
  • National Taiwan University Hospital

    Taipei, 10002

    Not yet recruiting
  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting
  • National Taiwan University Cancer Center (NTUCC)

    Taipei City, Taipei, 106

    Not yet recruiting

Other trials in Taiwan

Poland7 sites, 7 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

    Recruiting

Other trials in Poland

Bulgaria6 sites, 6 recruiting
  • Complex Oncology Center - Burgas

    Burgas, 8000

    Recruiting
  • MBAL Uni Hospital

    Panagyurishte, Pazardzhik, 4500

    Recruiting
  • Medical Center Futuremeds

    Plovdiv, 4000

    Not yet 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

    Recruiting

Other trials in Bulgaria

Slovakia6 sites, 6 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

    Recruiting

Other trials in Slovakia

Belgium5 sites, 5 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

    Recruiting

Other trials in Belgium

Czechia5 sites, 5 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

    Recruiting

Other trials in Czechia

Netherlands5 sites, 5 recruiting
  • Amphia Ziekenhuis, locatie Breda Molengracht

    Breda, North Brabant, 4818 CK

    Not yet recruiting
  • Ziekenhuis St. Jansdal

    Harderwijk, Gelderland, 3844 DG

    Recruiting
  • Frisius Medisch Centrum

    Leeuwarden, Provincie Friesland, 8934 AD

    Not yet recruiting
  • St. Antonius Ziekenhuis, locatie Utrecht

    Utrecht, 3543 AZ

    Recruiting
  • Isala, locatie Zwolle

    Zwolle, Overijssel, 8025 AB

    Recruiting

Other trials in Netherlands

Austria4 sites, 4 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

    Recruiting

Other trials in Austria

Canada4 sites, 4 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

    Recruiting

Other trials in Canada

Hungary4 sites, 4 recruiting
  • Farkasgyepui Tudogyogyintezet

    Farkasgyepű, Veszprém megye, 8582

    Not yet recruiting
  • Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház

    Gyula, Bekes County, 5700

    Recruiting
  • Fejér Vármegyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

    Not yet recruiting
  • Komárom-Esztergom Vármegyei Szent Borbála Kórház

    Tatabánya, 2800

    Not yet recruiting

Other trials in Hungary

Mexico4 sites, 4 recruiting
  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, Jalisco, 44340

    Recruiting
  • Instituto Nacional de Cancerologia

    Mexico City, 14080

    Not yet recruiting
  • Clinica Integral Internacional de Oncología

    Puebla City, 72530

    Recruiting
  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz de Ignacio de LA Llave, Veracruz, 91900

    Not yet recruiting

Other trials in Mexico

Israel2 sites, 2 recruiting
  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102

    Recruiting
  • Clalit Health Services through Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

Other trials in Israel

Saudi Arabia2 sites, 2 recruiting
  • King Saud University Medical City

    Riyadh, Riyadh Region, 11472

    Not yet recruiting
  • King Faisal Specialist Hospital and Research Center

    Riyadh, 11211

    Not yet recruiting

Other trials in Saudi Arabia

Switzerland2 sites, 2 recruiting
  • Inselspital Bern

    Bern, Canton of Bern, 3010

    Recruiting
  • UniversitätsSpital Zürich

    Zurich, 8091

    Recruiting

Other trials in Switzerland

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.

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 groups in NCT06758401
Study groupRoleWhat they receive
Sigvotatug Vedotin with PembrolizumabExperimentalParticipants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
Receives: Drug: Sigvotatug Vedotin; Drug: Pembrolizumab
Pembrolizumab MonotherapyActive comparatorParticipants 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.

  1. Overall Survival

    Overall survival defined as the duration from enrollment to death.

    Measured: Baseline to date of death from any cause (Approximately 2 years).

  2. 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)
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  1. First posted3 Jan 2025
  2. Study start23 Jul 2025
  3. Primary completion5 Sep 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
714 participants (estimated)
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

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.

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