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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

2026-11-03

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

Hopital Saint Joseph - Paris

Paris, Paris, France

Clinique Belharra

Bayonne, Pyrenees Atlantiques, France

And 147 more locations on ClinicalTrials.gov