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ACTIVE NOT RECRUITING
NCT06635824
PHASE3

Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

Sponsor: Genmab

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with locally advanced (unresectable stage IIIB/C) or programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the locally advanced (unresectable stage IIIB/C) or metastatic setting.

Official title: A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

191

Start Date

2024-11-25

Completion Date

2028-09-30

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Acasunlimab

IV infusion

DRUG

Pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion

Locations (247)

Arizona Blood and Cancer Specialists

Tucson, Arizona, United States

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente Vallejo Medical Center

Vallejo, California, United States

Ocala Oncology Center P.L.

Ocala, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Piedmont Cancer Institute Atlanta

Atlanta, Georgia, United States

Piedmont Cancer Institute - Sandy Springs (Atlanta) Office

Atlanta, Georgia, United States

Piedmont Cancer Institute - Fayetteville Office

Fayetteville, Georgia, United States

Piedmont Cancer Institute - Newnan Office

Newnan, Georgia, United States

Piedmont Cancer Institute - Stockbridge Office

Stockbridge, Georgia, United States

Kaiser Foundation Hospitals

Honolulu, Hawaii, United States

University of Illinois

Chicago, Illinois, United States

Community Cancer Center East Medical Oncology Hematology

Indianapolis, Indiana, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Washington University School of Medicine

St Louis, Missouri, United States

St. Francis Hospital - Grand Island

Grand Island, Nebraska, United States

Oncology Hematology West

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Stony Brook University Medical Center|University Medical Center

Stony Brook, New York, United States

Novant Health Pharmacy

Charlotte, North Carolina, United States

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Parkridge Medical Center

Chattanooga, Tennessee, United States

University of Tennessee Medical Center Cancer Institute

Knoxville, Tennessee, United States

Midtown Tennessee Oncology

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology-Austin Midtown

Austin, Texas, United States

Texas Oncology-Austin Central

Austin, Texas, United States

South Austin Cancer Ctr

Austin, Texas, United States

University of Virginia Hematology and Oncology

Charlottesville, Virginia, United States

Cancer Institute At Swedish Med Ctr

Seattle, Washington, United States

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Centro de Investigacion Pergamino S.A.

Pergamino, Buenos Aires, Argentina

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Parque S.A.

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Investigaciones CORI S.R.L.

La Rioja, Argentina

Chris OBrien LifeHouse

Camperdown, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Gold Coast Hospital

Southport, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

St Vincent's Hospital Melbourne

Fitzroy, Australia

Ballarat Oncology & Haematology Service

Wendouree, Australia

Kepler Universitatsklinikum Med Campus III

Linz, Austria

LKH - Rankweil

Rankweil, Austria

Standort Penzing der Klinik Ottakring

Vienna, Austria

Wiener Gesundheitsverbund - Klinik Floridsdorf

Vienna, Austria

C. H. U. St-Pierre

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Bruxelles

Brussels, Belgium

Grand Hôpital de Charleroi

Gilly, Belgium

Jessa Ziekenhuis Hospital

Hasselt, Belgium

CHU de Liège

Liège, Belgium

AZ Sint-Maarten

Mechelen, Belgium

AZ Delta

Roeselare, Belgium

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

MultiHemo Servicos Medicos

Recife, Pernambuco, Brazil

Instituto D'Or Pesquisa e Ensino - Rio de Janeiro

Rio de Janeiro, Rio Do Janeiro, Brazil

Hospital de Clinicas de Ijui

Ijuí, Rio Grande do Sul, Brazil

Centro Gaucho Integrado - Mae de Deus Center

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande Do Su, Brazil

Clínica de Neoplasias Litoral Ltda.

Itajaí, Santa Catarina, Brazil

BP A Beneficencia Portuguesa de Sao Paulo

São Paulo, São Paulo, Brazil

Centro Paulista de Oncologia S.A.

São Paulo, São Paulo, Brazil

Hospital Sirio-Libanes

São Paulo, São Paulo, Brazil

Oncoclínicas do Brasil Serviços Médicos SA

Belo Horizonte, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Oncoclínicas Rio de Janeiro

Rio de Janeiro, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, Brazil

MHAT Heart and Brain - Pleven

Pleven, Bulgaria

Complex Oncology Center - Plovdiv, EOOD

Plovdiv, Bulgaria

MHAT "Serdika", EOOD

Sofia, Bulgaria

MHAT for women's health - Nadezhda, OOD

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

UMHAT 'SofiaMed', OOD

Sofia, Bulgaria

William Osler Health System-Brampton Civic Hospital|William Osler Health System

Brampton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

MUHC - Jewish General Hospital

Montreal, Quebec, Canada

FALP - Fundación Arturo López Pérez

Providencia, Chile

Centro de Investigacion Clinica Bradford Hill

Santiago, Chile

IRAM - Instituto de Radio Medicina

Santiago, Chile

Oncocentro APYS

Viña del Mar, Chile

General Hospital Dubrovnik

Dubrovnik, Croatia

Specialty Hospital Medico

Rijeka, Croatia

Department for Pulmonary Diseases University Hospital Centre Zagreb

Zagreb, Croatia

Sestre milosrdnice University Hospital Center

Zagreb, Croatia

North Estonia Medical Centre Foundation

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Institut Paoli Calmettes

Marseille, Bouches-du-Rhône, France

Institut Bergonié

Bordeaux, Gironde, France

Clinique Belharra

Bayonne, Pyrenees Atlantiques, France

Institut Sainte Catherine

Avignon, Vaculuse, France

Institut Gustave Roussy

Villejuif, Val De Marne, France

CHU Angers - Hôpital Larrey

Angers, France

Centre Hospitalier de la côte Basque

Bayonne, France

Hôpital Ambroise Paré

Boulogne-Billancourt, France

Centre Hospitalier Intercommunal de Creteil (CHIC)

Créteil, France

Hopital Albert Calmette - CHU Lille

Lille, France

Centre Léon Bérard

Lyon, France

Assistance Publique-Hôpitaux de Marseille

Marseille, France

CH de Mulhouse - Hôpital Emile Muller

Mulhouse, France

Hôpital Privé du Confluent

Nantes, France

Hopital Saint Joseph - Paris

Paris, France

Institut Curie

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

ICO - Site René Gauducheau

Saint-Herblain, France

Hôpital Sainte Musse

Toulon, France

Klinikum Esslingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, Germany

MHH Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany

MVZ Martha-Maria Halle-Doelau

Halle, Saxony-Anhalt, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, Schleswig-Holstein, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

Vivantes Klinikum im Friedrichshain

Berlin, Germany

Vivantes Klinikum Neukoelln

Berlin, Germany

Vivantes Klinikum Spandau

Berlin, Germany

Asklepios Klinik Harburg

Hamburg, Germany

Alexandra General Hospital

Athens, Greece

Henry Dunant Hospital Center

Athens, Greece

University General Hospital Attikon

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

University General Hospital of Larissa

Larissa, Greece

Bioclinic Thessaloniki

Thessaloniki, Greece

Interbalkan Hospital of Thessaloniki

Thessaloniki, Greece

Orszagos Koranyi Pulmonologiai Intezet

Budapest, Hungary

Bács-Kiskun County Hospital BKMK

Kecskemét, Hungary

Cork University Hospital

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

St James's Hospital

Dublin, Ireland

St Vincent's University Hospital

Dublin, Ireland

University Hospital Limerick

Limerick, Ireland

Waterford Regional Hospital

Waterford, Ireland

Fondazione IRCCS San Gerardo dei Tintori

Monza, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

AOU Università degli Studi della Campania "Luigi Vanvitelli"

Naples, Napoli, Italy

IRCCS Centro di Riferimento Oncologico

Aviano, Pordenone, Italy

IRCCS Policlinico Universitario Agostino Gemelli

Rome, Roma, Italy

AOU San Luigi Gonzaga

Orbassano, Torino, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Istituto di Candiolo

Candiolo, Italy

Istituto Nazionale per la Ricerca sul Cancro di Genova

Genova, Italy

IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

Meldola, Italy

IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Ospedale Santa Maria delle Croci

Ravenna, Italy

Regina Elena National Cancer Institute

Roma, Italy

CRC - Centro Ricerche Cliniche di Verona S.r.l.

Verona, Italy

Shikoku Cancer Center

Matsuyama, Ehime, Japan

JCHO Kyushu Hospital

Kitakyushu-shi, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Kobe Minimally Invasive Cancer Center

Kobe, Hyōgo, Japan

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

Juntendo University Hospital

Bunkyō City, Tokyo-To, Japan

Nippon Medical School Hospital

Bunkyō City, Japan

National Cancer Center Hospital

Chūōku, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

NHO Hokkaido Cancer Center

Hokkaido, Japan

Cancer Institute Hospital of JFCR

Kōtō City, Japan

Kurashiki Central Hospital

Kurashiki-shi, Japan

Kurume University Hospital

Kurume-shi, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

NHO Nagoya Medical Center

Nagoya, Japan

Miyagi Cancer Center

Natori-shi, Japan

Okayama University Hospital

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Osaka, Japan

Gunma Prefectural Cancer Center

Ota-shi, Japan

Kanagawa Cancer Center

Yokohama, Japan

Amsterdam UMC Locatie VUMC

Amsterdam, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

St. Jansdal Ziekenhuis

Harderwijk, Netherlands

Zuyderland Medisch Centrum - Heerlen

Heerlen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Radboudumc

Nijmegen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Isala Zwolle

Zwolle, Netherlands

Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie

Koszalin, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)

Lodz, Poland

Aidport sp z o.o.

Skorzewo, Poland

Instytut Gruzlicy i Chorob Pluc w Warszawie

Warsaw, Poland

Maria Sklodowska-Curie National Research Institute of Oncology (Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie)

Warsaw, Poland

Unidade Local de Saude de Coimbra E P E

Coimbra, Portugal

Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano

Matosinhos Municipality, Portugal

Hospital CUF Porto

Porto, Portugal

Unidade Local de Saude da Arrabida E. P. E

Setúbal, Portugal

Pan American Oncology Trials, LLC

San Juan, Puerto Rico

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

National Cancer Center Korea

Goyang-si, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

ICO l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Córdoba, Spain

Complejo Hospitalario Universitario de Santiago CHUS

Santiago de Compostela, La Coruña, Spain

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

H.C. Hospitales S.L.

Marbella, Málaga, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

ICO Girona

Girona, Spain

Facility name: Clínica Universidad de Navarra

Madrid, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

IVO - Instituto Valenciano de Oncologia

Valencia, Spain

National Taiwan University Hospital Yunlin Branch

Douliu, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital,Linkou

Taoyuan, Taiwan

Adana City Hospital

Adana, Turkey (Türkiye)

Medical Park Seyhan Hospital

Adana, Turkey (Türkiye)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

İ.E.Ü. Medicalpoint İzmir Hastanesi

Izmir, Turkey (Türkiye)

Beatson West of Scotland Cancer Care

Glasgow, Strathclyde, United Kingdom

Barts Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Nottingham University Hospitals City Campus

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom