Forsøk for å evaluere Acasunlimab og Pembrolizumab kombinasjonsoverlegenhet over standardbehandling Docetaxel ved ikke-småcellet lungekreft (ABBIL1TY NSCLC-06)
En prospektiv, åpen, randomisert, fase 3-studie av Acasunlimab (GEN1046) i kombinasjon med Pembrolizumab versus Docetaxel hos personer med PD-L1 positiv metastatisk ikke-småcellet lungekreft etter behandling med en PD-1/PD-L1-hemmer og Platinaholdig kjemoterapi (ABBIL1TY NSCLC-06)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants must have:
- non-small cell lung cancer that are locally advanced, unresectable stage IIIB/C or has metastasized (spread)
- tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)
- been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially (irrespective of the order).
Other eligibility criteria will also apply.
Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows:
- Acasunlimab (100 milligrams [mg]) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or
- Docetaxel 75 milligrams per meter squared (mg/m^2) once every 3 weeks (Q3W).
The estimated trial duration for a participant will vary but may be up to 5 years, consisting of:
- An optional 3-month pre-screening period
- A 28-day screening period
- Up to 2 years of treatment
- A 90-day safety follow-up period
- Post-treatment follow-up.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Ciudad Autonoma Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires
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La Rioja, Argentina
- Investigaciones CORI S.R.L.
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Buenos Aires
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La Plata, Buenos Aires, Argentina
- Hospital Italiano de La Plata
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Pergamino, Buenos Aires, Argentina
- Centro de Investigacion Pergamino S.A.
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Ciudad Autonoma Buenos Aires
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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
- Instituto Medico Especializado Alexander Fleming
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina
- Sanatorio Parque S.A.
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Fitzroy, Australia
- St Vincent's Hospital Melbourne
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Wendouree, Australia
- Ballarat Oncology & Haematology Service
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New South Wales
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Camperdown, New South Wales, Australia
- Chris OBrien LifeHouse
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Sydney, New South Wales, Australia
- Westmead Hospital
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Queensland
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Southport, Queensland, Australia
- Gold Coast Hospital
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South Australia
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Bedford Park, South Australia, Australia
- Flinders Medical Centre
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Western Australia
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Perth, Western Australia, Australia
- Sir Charles Gairdner Hospital
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Subiaco, Western Australia, Australia
- St John of God Subiaco Hospital
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Brussels, Belgia
- C. H. U. St-Pierre
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Brussels, Belgia
- Universitair Ziekenhuis Bruxelles
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Brussels, Belgia
- Cliniques Universitaires Saint-Luc
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Gilly, Belgia
- Grand Hôpital de Charleroi
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Hasselt, Belgia
- Jessa Ziekenhuis Hospital
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Liège, Belgia
- CHU de Liège
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Mechelen, Belgia
- AZ Sint-Maarten
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Roeselare, Belgia
- AZ Delta
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Belo Horizonte, Brasil
- Oncoclínicas do Brasil Serviços Médicos SA
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Porto Alegre, Brasil
- Hospital Ernesto Dornelles
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Rio de Janeiro, Brasil
- Oncoclínicas Rio de Janeiro
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Santo André, Brasil
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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Paraná
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Curitiba, Paraná, Brasil
- Hospital Erasto Gaertner
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Pernambuco
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Recife, Pernambuco, Brasil
- MultiHemo Servicos Medicos
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Rio Do Janeiro
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Rio de Janeiro, Rio Do Janeiro, Brasil
- Instituto D'Or Pesquisa e Ensino - Rio de Janeiro
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Rio Grande Do Su
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Porto Alegre, Rio Grande Do Su, Brasil
- Hospital São Lucas da PUCRS
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasil
- Hospital de Clinicas de Ijui
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Porto Alegre, Rio Grande do Sul, Brasil
- Centro Gaucho Integrado - Mae de Deus Center
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Santa Catarina
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Itajaí, Santa Catarina, Brasil
- Clínica de Neoplasias Litoral Ltda.
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São Paulo
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São Paulo, São Paulo, Brasil
- BP A Beneficencia Portuguesa de Sao Paulo
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São Paulo, São Paulo, Brasil
- Centro Paulista de Oncologia S.A.
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São Paulo, São Paulo, Brasil
- Hospital Sirio-Libanes
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Pleven, Bulgaria
- MHAT Heart and Brain - Pleven
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Plovdiv, Bulgaria
- Complex Oncology Center - Plovdiv, EOOD
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Sofia, Bulgaria
- UMHAT "Sv. Ivan Rilski", EAD
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Sofia, Bulgaria
- MHAT for women's health - Nadezhda, OOD
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Sofia, Bulgaria
- MHAT "Serdika", EOOD
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Sofia, Bulgaria
- UMHAT 'SofiaMed', OOD
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Ontario
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Brampton, Ontario, Canada
- William Osler Health System-Brampton Civic Hospital|William Osler Health System
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Kingston, Ontario, Canada
- Kingston Health Sciences Centre
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Toronto, Ontario, Canada
- Princess Margaret Cancer Centre - University Health Network
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Quebec
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Montreal, Quebec, Canada
- MUHC - Jewish General Hospital
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Providencia, Chile
- FALP - Fundación Arturo López Pérez
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Santiago, Chile
- Centro de Investigacion Clinica Bradford Hill
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Santiago, Chile
- IRAM - Instituto de Radio Medicina
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Viña del Mar, Chile
- Oncocentro APYS
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Tallinn, Estland
- North Estonia Medical Centre Foundation
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Tartu, Estland
- Tartu University Hospital
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Arizona
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Tucson, Arizona, Forente stater, 85712
- Arizona Blood and Cancer Specialists
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California
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Los Angeles, California, Forente stater, 90089
- Usc Norris Comprehensive Cancer Center
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Vallejo, California, Forente stater, 94589
- Kaiser Permanente Vallejo Medical Center
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Florida
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Ocala, Florida, Forente stater, 34474
- Ocala Oncology Center P.L.
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Orlando, Florida, Forente stater, 32806
- Orlando Regional Medical Center
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Georgia
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Athens, Georgia, Forente stater, 30607
- University Cancer & Blood Center, LLC
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Atlanta, Georgia, Forente stater, 30318
- Piedmont Cancer Institute Atlanta
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Atlanta, Georgia, Forente stater, 30328
- Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
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Fayetteville, Georgia, Forente stater, 30214
- Piedmont Cancer Institute - Fayetteville Office
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Newnan, Georgia, Forente stater, 30265
- Piedmont Cancer Institute - Newnan Office
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Stockbridge, Georgia, Forente stater, 30281
- Piedmont Cancer Institute - Stockbridge Office
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Hawaii
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Honolulu, Hawaii, Forente stater, 96817
- Kaiser Foundation Hospitals
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois
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Indiana
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Indianapolis, Indiana, Forente stater, 46219
- Community Cancer Center East Medical Oncology Hematology
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Baptist Health Lexington
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Louisville, Kentucky, Forente stater, 40202
- Norton Cancer Institute
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Pikeville, Kentucky, Forente stater, 41501
- Pikeville Medical Center
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Nebraska
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Grand Island, Nebraska, Forente stater, 68803
- St. Francis Hospital - Grand Island
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Omaha, Nebraska, Forente stater, 68124
- Oncology Hematology West
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Omaha, Nebraska, Forente stater, 68130
- Oncology Hematology West, PC dba Nebraska Cancer Specialists
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New York
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Stony Brook, New York, Forente stater, 11790
- Stony Brook University Medical Center|University Medical Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Novant Health Pharmacy
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Winston-Salem, North Carolina, Forente stater, 27103
- Novant Health Oncology Specialists
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny General Hospital
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Parkridge Medical Center
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Knoxville, Tennessee, Forente stater, 37920
- University of Tennessee Medical Center Cancer Institute
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Nashville, Tennessee, Forente stater, 37205
- Tennessee Oncology
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Nashville, Tennessee, Forente stater, 37203
- Midtown Tennessee Oncology
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Texas
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Austin, Texas, Forente stater, 78705
- Texas Oncology-Austin Midtown
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Austin, Texas, Forente stater, 78731
- Texas Oncology-Austin Central
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Austin, Texas, Forente stater, 78745
- South Austin Cancer Ctr
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Virginia
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Charlottesville, Virginia, Forente stater, 22903
- University of Virginia Hematology and Oncology
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Washington
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Seattle, Washington, Forente stater, 98104
- Cancer Institute At Swedish Med Ctr
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Angers, Frankrike
- CHU Angers - Hôpital Larrey
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Bayonne, Frankrike
- Centre Hospitalier de la côte Basque
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Boulogne-Billancourt, Frankrike
- Hôpital Ambroise Paré
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Créteil, Frankrike
- Centre Hospitalier Intercommunal de Creteil (CHIC)
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Lille, Frankrike
- Hopital Albert Calmette - CHU Lille
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Lyon, Frankrike
- Centre Léon Bérard
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Marseille, Frankrike
- Assistance Publique-Hôpitaux de Marseille
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Mulhouse, Frankrike
- CH de Mulhouse - Hôpital Emile Muller
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Nantes, Frankrike
- Hôpital Privé du Confluent
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Paris, Frankrike
- Institut Curie
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Rennes, Frankrike
- CHU Rennes - Hopital Pontchaillou
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Saint-Herblain, Frankrike
- ICO - Site René Gauducheau
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Toulon, Frankrike
- Hôpital Sainte Musse
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike
- Institut Paoli Calmettes
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Gironde
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Bordeaux, Gironde, Frankrike
- Institut Bergonié
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Paris
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Paris, Paris, Frankrike
- Hopital Saint Joseph - Paris
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Pyrenees Atlantiques
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Bayonne, Pyrenees Atlantiques, Frankrike
- Clinique Belharra
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Vaculuse
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Avignon, Vaculuse, Frankrike
- Institut Sainte Catherine
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Val de Marne
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Villejuif, Val de Marne, Frankrike
- Institut Gustave Roussy
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-
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Athens, Hellas
- Alexandra General Hospital
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Athens, Hellas
- University General Hospital Attikon
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Athens, Hellas
- Henry Dunant Hospital Center
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Heraklion, Hellas
- University General Hospital of Heraklion
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Larissa, Hellas
- University General Hospital of Larissa
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Thessaloniki, Hellas
- Interbalkan Hospital of Thessaloniki
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Thessaloniki, Hellas
- Bioclinic Thessaloniki
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Cork, Irland
- Cork University Hospital
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Dublin, Irland
- St Vincent's University Hospital
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Limerick, Irland
- University Hospital Limerick
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Waterford, Irland
- Waterford Regional Hospital
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Dublin
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Dublin, Dublin, Irland
- Beaumont Hospital
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Dublin, Dublin, Irland
- St James's Hospital
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Bergamo, Italia
- ASST Papa Giovanni XXIII
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Candiolo, Italia
- Istituto di Candiolo
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Meldola, Italia
- IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
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Milan, Italia
- IRCCS Istituto Nazionale dei Tumori
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Genova
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Genova, Genova, Italia
- Istituto Nazionale per la Ricerca sul Cancro di Genova
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Milano
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Monza, Milano, Italia
- Fondazione IRCCS San Gerardo dei Tintori
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Rozzano, Milano, Italia
- Istituto Clinico Humanitas
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Napoli
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Naples, Napoli, Italia
- AOU Università degli Studi della Campania "Luigi Vanvitelli"
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Pordenone
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Aviano, Pordenone, Italia
- IRCCS Centro di Riferimento Oncologico
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Ravenna
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Ravenna, Ravenna, Italia
- Ospedale Santa Maria delle Croci
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Roma
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Roma, Roma, Italia
- Regina Elena National Cancer Institute
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Rome, Roma, Italia
- IRCCS Policlinico Universitario Agostino Gemelli
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Torino
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Orbassano, Torino, Italia
- AOU San Luigi Gonzaga
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Verona
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Verona, Verona, Italia
- CRC - Centro Ricerche Cliniche di Verona S.r.l.
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-
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-
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Bunkyō City, Japan
- Nippon Medical School Hospital
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Chūōku, Japan
- National Cancer Center Hospital
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Fukuoka, Japan
- NHO Kyushu Cancer Center
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Hokkaido, Japan
- NHO Hokkaido Cancer Center
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Kurashiki-shi, Japan
- Kurashiki Central Hospital
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Kurume-shi, Japan
- Kurume University Hospital
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Kōtō City, Japan
- Cancer Institute Hospital of JFCR
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Nagoya, Japan
- Aichi Cancer Center Hospital
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Nagoya, Japan
- NHO Nagoya Medical Center
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Natori-shi, Japan
- Miyagi Cancer Center
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Okayama, Japan
- Okayama University Hospital
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Osaka, Japan
- Osaka International Cancer Institute
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Osaka, Japan
- Osaka Medical and Pharmaceutical University Hospital
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Ota-shi, Japan
- Gunma Prefectural Cancer Center
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Yokohama, Japan
- Kanagawa Cancer Center
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Ehime
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Matsuyama, Ehime, Japan
- Shikoku Cancer Center
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Fukuoka
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Kitakyushu-shi, Fukuoka, Japan
- JCHO Kyushu Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan
- Hiroshima University Hospital
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Hyōgo
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Kobe, Hyōgo, Japan
- Kobe Minimally Invasive Cancer Center
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Kumamoto
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Kumamoto, Kumamoto, Japan
- Saiseikai Kumamoto Hospital
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Osaka
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Osakasayama-shi, Osaka, Japan
- Kindai University Hospital
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Tokyo-To
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Bunkyō City, Tokyo-To, Japan
- Juntendo University Hospital
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Dubrovnik, Kroatia
- General Hospital Dubrovnik
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Rijeka, Kroatia
- Specialty Hospital Medico
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Zagreb, Kroatia
- Sestre milosrdnice University Hospital Center
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Zagreb, Kroatia
- Department for Pulmonary Diseases University Hospital Centre Zagreb
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Amsterdam, Nederland
- Antoni van Leeuwenhoek
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Amsterdam, Nederland
- Amsterdam UMC Locatie VUMC
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Harderwijk, Nederland
- St. Jansdal Ziekenhuis
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Heerlen, Nederland
- Zuyderland Medisch Centrum - Heerlen
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Leiden, Nederland
- Leiden University Medical Center
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Nijmegen, Nederland
- Radboudumc
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Rotterdam, Nederland
- Erasmus Medisch Centrum
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Utrecht, Nederland
- Universitair Medisch Centrum Utrecht
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Zwolle, Nederland
- Isala Zwolle
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Koszalin, Polen
- Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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Krakow, Polen
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
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Lodz, Polen
- Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)
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Skorzewo, Polen
- Aidport sp z o.o.
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Warsaw, Polen
- Instytut Gruzlicy i Chorob Pluc w Warszawie
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Warsaw, Polen
- Maria Sklodowska-Curie National Research Institute of Oncology (Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie)
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Coimbra, Portugal
- Unidade Local de Saude de Coimbra E P E
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Matosinhos Municipality, Portugal
- Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
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Porto, Portugal
- Hospital CUF Porto
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Setúbal, Portugal
- Unidade Local de Saude da Arrabida E. P. E
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Puerto Rico
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San Juan, Puerto Rico, Puerto Rico, 902
- Pan American Oncology Trials, LLC
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San Juan, Puerto Rico, Puerto Rico, 917
- Auxilio Mutuo Cancer Center
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-
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Madrid, Spania
- Hospital Universitario HM Sanchinarro
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Madrid, Spania
- Facility name: Clínica Universidad de Navarra
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Málaga, Spania
- Hospital Quironsalud Malaga
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Valencia, Spania
- IVO - Instituto Valenciano de Oncologia
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Alicante
-
Alicante, Alicante, Spania
- Hospital General Universitario Dr. Balmis
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Barcelona
-
Barcelona, Barcelona, Spania
- Hospital Universitari Vall d'Hebron
-
L'Hospitalet de Llobregat, Barcelona, Spania
- ICO l'Hospitalet
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Córdoba
-
Córdoba, Córdoba, Spania
- Hospital Universitario Reina Sofia
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Girona
-
Girona, Girona, Spania
- ICO Girona
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La Coruña
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Santiago de Compostela, La Coruña, Spania
- Complejo Hospitalario Universitario de Santiago CHUS
-
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Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spania
- Complejo Hospitalario Universitario Insular Materno-Infantil
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Madrid
-
Madrid, Madrid, Spania
- Hospital Universitario 12 de Octubre
-
Madrid, Madrid, Spania
- Hospital General Universitario Gregorio Marañon
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Pozuelo de Alarcón, Madrid, Spania
- Hospital Universitario Quironsalud Madrid
-
-
Málaga
-
Marbella, Málaga, Spania
- H.C. Hospitales S.L.
-
Málaga, Málaga, Spania
- Hospital Universitario Virgen de la Victoria
-
-
Navarre
-
Pamplona, Navarre, Spania
- Clinica Universidad de Navarra
-
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Sevilla
-
Seville, Sevilla, Spania
- Hospital Universitario Virgen Macarena
-
Seville, Sevilla, Spania
- Hospital Universitario Virgen del Rocio
-
-
Valencia
-
Valencia, Valencia, Spania
- Hospital Universitari i Politecnic La Fe
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-
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-
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London, Storbritannia
- Guy's Hospital
-
London, Storbritannia
- Barts Hospital
-
Manchester, Storbritannia
- The Christie Hospital
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Nottingham, Storbritannia
- Nottingham University Hospitals City Campus
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Plymouth, Storbritannia
- Derriford Hospital
-
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Strathclyde
-
Glasgow, Strathclyde, Storbritannia
- Beatson West of Scotland Cancer Care
-
-
-
-
-
Cheongju-si, Sør -Korea
- Chungbuk National University Hospital
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Daegu, Sør -Korea
- Keimyung University Dongsan Hospital
-
Goyang-si, Sør -Korea
- National Cancer Center Korea
-
Seoul, Sør -Korea
- Asan Medical Center
-
Seoul, Sør -Korea
- Samsung Medical Center
-
Seoul, Sør -Korea
- Severance Hospital, Yonsei University Health System
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Sør -Korea
- Ajou University Hospital
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-
-
-
-
Douliu, Taiwan
- National Taiwan University Hospital Yunlin Branch
-
Tainan, Taiwan
- National Cheng Kung University Hospital
-
Taipei, Taiwan
- Taipei Veterans General Hospital
-
Taipei, Taiwan
- National Taiwan University Cancer Center
-
Taoyuan City, Taiwan
- Chang Gung Memorial Hospital,Linkou
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-
-
-
-
Adana, Tyrkia (Türkiye)
- Adana City Hospital
-
Adana, Tyrkia (Türkiye)
- Medical Park Seyhan Hospital
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Ankara, Tyrkia (Türkiye)
- Gulhane Training and Research Hospital
-
Ankara, Tyrkia (Türkiye)
- Ankara City Hospital
-
Ankara, Tyrkia (Türkiye)
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Ankara, Tyrkia (Türkiye)
- Liv Hospital Ankara
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Istanbul, Tyrkia (Türkiye)
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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Istanbul, Tyrkia (Türkiye)
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
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Izmir, Tyrkia (Türkiye)
- İ.E.Ü. Medicalpoint İzmir Hastanesi
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-
-
-
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Hamburg, Tyskland
- Asklepios Klinik Harburg
-
-
Baden-Wurttemberg
-
Esslingen am Neckar, Baden-Wurttemberg, Tyskland
- Klinikum Esslingen GmbH
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Heidelberg, Baden-Wurttemberg, Tyskland
- Thoraxklinik Heidelberg gGmbH
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Lower Saxony
-
Göttingen, Lower Saxony, Tyskland
- Universitaetsmedizin Goettingen
-
Hanover, Lower Saxony, Tyskland
- MHH Medizinische Hochschule Hannover
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland
- Johannes Gutenberg University Mainz
-
-
Saxony
-
Dresden, Saxony, Tyskland
- Universitatsklinikum Carl Gustav Carus Dresden
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Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland
- MVZ Martha-Maria Halle-Doelau
-
-
Schleswig-Holstein
-
Großhansdorf, Schleswig-Holstein, Tyskland
- LungenClinic Grosshansdorf GmbH
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-
State of Berlin
-
Berlin, State of Berlin, Tyskland
- Vivantes Klinikum Neukoelln
-
Berlin, State of Berlin, Tyskland
- Evangelische Lungenklinik Berlin
-
Berlin, State of Berlin, Tyskland
- Vivantes Klinikum im Friedrichshain
-
Berlin, State of Berlin, Tyskland
- Vivantes Klinikum Spandau
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-
-
-
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Budapest, Ungarn
- Orszagos Koranyi Pulmonologiai Intezet
-
Kecskemét, Ungarn
- Bács-Kiskun County Hospital BKMK
-
-
-
-
-
Linz, Østerrike
- Kepler Universitatsklinikum Med Campus III
-
Rankweil, Østerrike
- LKH - Rankweil
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Vienna, Østerrike
- Standort Penzing der Klinik Ottakring
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Vienna, Østerrike
- Wiener Gesundheitsverbund - Klinik Floridsdorf
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
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Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or metastatic NSCLC (stage IV) with known subtype.
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Participant has progressed radiographically on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting.
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Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the locally advanced (unresectable stage IIIB/C) or metastatic setting at a sponsor-designated central laboratory.
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Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
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Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
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Participant has a life expectancy of ≥3 months.
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Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.
Key Exclusion Criteria:
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Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.
- Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to targeted therapies.
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Participants with newly identified, untreated or unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
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Prior treatment with docetaxel for NSCLC.
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Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
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Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arm A
Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days). |
IV infusion
Andre navn:
IV infusion |
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Aktiv komparator: Arm B
Docetaxel, 75 mg/m^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days). |
IV infusion |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (OS)
Tidsramme: Up to approximately 5 years
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OS is defined as the time from date of randomization to date of death due to any cause. |
Up to approximately 5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Antall deltakere med uønskede hendelser (AE)
Tidsramme: Fra første dose til slutten av studien (ca. 5 år)
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Fra første dose til slutten av studien (ca. 5 år)
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|
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Tid til behandling av behandling på grunn av AE
Tidsramme: Fra første dose til slutten av studien (ca. 5 år)
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Fra første dose til slutten av studien (ca. 5 år)
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Plasmakonsentrasjon av Acasunlimab
Tidsramme: Predose og postdose ved flere tidspunkter i syklus 1-4 (sykluslengde=42 dager)
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Predose og postdose ved flere tidspunkter i syklus 1-4 (sykluslengde=42 dager)
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Progression-Free Survival (PFS)
Tidsramme: Up to approximately 5 years
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PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. |
Up to approximately 5 years
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Confirmed Overall Response Rate (ORR)
Tidsramme: Up to approximately 5 years
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Confirmed ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 5 years
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Duration of Response (DOR)
Tidsramme: Up to approximately 5 years
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DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 5 years
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Number of Participants With Anti-drug Antibodies (ADAs) to Acasunlimab
Tidsramme: Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
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Serum samples will be analyzed using validated, specific, and sensitive immunoassay method. Samples will be screened for ADAs binding to acasunlimab and the titer of confirmed positive/negative samples will be reported. |
Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
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Change From Baseline in Functional Assessment of Cancer Therapy Item GP5 (FACIT-GP5; Version 4) Score
Tidsramme: Baseline up to approximately 2 years
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Participant's global assessment of treatment tolerability will be assessed by FACIT-GP5. FACIT-GP5 asks participants to rate their agreement with the following statement, "I am bothered by side effects of treatment" in the past 7 days. Responses will be captured on a 5-point Likert scale ranging from 0 to 4 indicating 0 as not at all to 4 as very much bothered by side effects. |
Baseline up to approximately 2 years
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Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Tidsramme: Up to approximately 2 years
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The PRO-CTCAE allows participants to report on the frequency, severity, and interference of patient-reported symptoms. For each AE, there are between one and three items to assess the frequency, severity, and/or interference with activities related to that AE. All PRO-CTCAE responses will be scored from 0 to 4 for frequency indicating (0= never to 4= almost constantly), severity (0= none to 4= very severe) and interference with usual or daily activities (0= not at all to 4= very much). |
Up to approximately 2 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Official, Genmab
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Organiske kjemikalier
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Taxoider
- Cyclodecanes
- Diterpenes
- Docetaxel
- pembrolizumab
Andre studie-ID-numre
- GCT1046-06
- 2024-512998-27-00 (Ctis)
- jRCT2051240178 (Registeridentifikator: Japan Registry of Clinical Trials)
- 1010602 (Registeridentifikator: UK Research Summary Database)
- NL-OMON57246 (Registeridentifikator: NL CCMO)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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