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Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
Sponsor: Genmab
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
2026-11-03
Healthy Volunteers
No
Interventions
Acasunlimab
IV infusion
Pembrolizumab
IV infusion
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
Hopital Saint Joseph - Paris
Paris, Paris, France
Clinique Belharra
Bayonne, Pyrenees Atlantiques, France