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)

Status: Recruiting
Location: See all (221) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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 metastatic setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).

• 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 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 metastatic disease setting.

• Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.

• Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.

• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.

• Participant has a life expectancy of ≥3 months.

• Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.

Locations
United States
California
Usc Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Kaiser Permanente Vallejo Medical Center
RECRUITING
Vallejo
Florida
Ocala Oncology Center P.L.
RECRUITING
Ocala
Orlando Regional Medical Center
RECRUITING
Orlando
Georgia
University Cancer & Blood Center, LLC
RECRUITING
Athens
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
RECRUITING
Atlanta
Piedmont Cancer Institute Atlanta
RECRUITING
Atlanta
Piedmont Cancer Institute - Fayetteville Office
RECRUITING
Fayetteville
Piedmont Cancer Institute - Newnan Office
RECRUITING
Newnan
Piedmont Cancer Institute - Stockbridge Office
RECRUITING
Stockbridge
Hawaii
Kaiser Foundation Hospitals
RECRUITING
Honolulu
Illinois
University of Illinois
RECRUITING
Chicago
Indiana
Community Cancer Center East Medical Oncology Hematology
RECRUITING
Indianapolis
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Norton Cancer Institute
RECRUITING
Louisville
Pikeville Medical Center
RECRUITING
Pikeville
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Novant Health Oncology Specialists
RECRUITING
Winston-salem
Nebraska
St. Francis Hospital - Grand Island
RECRUITING
Grand Island
Oncology Hematology West
RECRUITING
Omaha
Oncology Hematology West, PC dba Nebraska Cancer Specialists
RECRUITING
Omaha
New York
Clinical Research Alliance
RECRUITING
Westbury
Pennsylvania
University of Pennsylvania Health System
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
Parkridge Medical Center
RECRUITING
Chattanooga
University of Tennessee Medical Center Cancer Institute
RECRUITING
Knoxville
Midtown Tennessee Oncology
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
South Austin Cancer Ctr
RECRUITING
Austin
Texas Oncology-Austin Central
RECRUITING
Austin
Texas Oncology-Austin Midtown
RECRUITING
Austin
Virginia
University of Virginia Hematology and Oncology
RECRUITING
Charlottesville
Washington
Cancer Institute At Swedish Med Ctr
RECRUITING
Seattle
Other Locations
Argentina
Instituto Medico Especializado Alexander Fleming
RECRUITING
Buenos Aires
Hospital Italiano de La Plata
RECRUITING
La Plata
Investigaciones CORI S.R.L.
RECRUITING
La Rioja
Centro de Investigacion Pergamino S.A.
RECRUITING
Pergamino
Australia
Chris OBrien LifeHouse
RECRUITING
Camperdown
St Vincent's Hospital Melbourne
RECRUITING
Fitzroy
Sir Charles Gairdner Hospital
RECRUITING
Perth
Gold Coast Hospital
RECRUITING
Southport
St John of God Subiaco Hospital
RECRUITING
Subiaco
Westmead Hospital
RECRUITING
Sydney
Ballarat Oncology & Haematology Service
RECRUITING
Wendouree
Austria
Kepler Universitatsklinikum Med Campus III
RECRUITING
Linz
LKH - Rankweil
RECRUITING
Rankweil
Wiener Gesundheitsverbund - Klinik Floridsdorf
RECRUITING
Vienna
Belgium
C. H. U. St-Pierre
RECRUITING
Brussels
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Universitair Ziekenhuis Bruxelles
RECRUITING
Brussels
Grand Hôpital de Charleroi
RECRUITING
Gilly
Jessa Ziekenhuis Hospital
RECRUITING
Hasselt
CHU de Liège
RECRUITING
Liège
AZ Sint-Maarten
RECRUITING
Mechelen
AZ Delta
RECRUITING
Roeselare
Brazil
Oncoclínicas do Brasil Serviços Médicos SA
RECRUITING
Belo Horizonte
Hospital Erasto Gaertner
RECRUITING
Curitiba
Hospital de Clinicas de Ijui
RECRUITING
Ijuí
Clínica de Neoplasias Litoral Ltda.
RECRUITING
Itajaí
Centro Gaucho Integrado - Mae de Deus Center
RECRUITING
Porto Alegre
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
MultiHemo Servicos Medicos
RECRUITING
Recife
Instituto D'Or Pesquisa e Ensino - Rio de Janeiro
RECRUITING
Rio De Janeiro
Oncoclínicas Rio de Janeiro
RECRUITING
Rio De Janeiro
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
RECRUITING
Santo André
BP A Beneficencia Portuguesa de Sao Paulo
RECRUITING
São Paulo
Centro Paulista de Oncologia S.A.
RECRUITING
São Paulo
Hospital Sirio-Libanes
RECRUITING
São Paulo
Bulgaria
MHAT Heart and Brain - Pleven
RECRUITING
Pleven
Complex Oncology Center - Plovdiv, EOOD
RECRUITING
Plovdiv
MHAT for women's health - Nadezhda, OOD
RECRUITING
Sofia
MHAT Serdika, EOOD
RECRUITING
Sofia
UMHAT 'SofiaMed', OOD
RECRUITING
Sofia
UMHAT Sv. Ivan Rilski, EAD
RECRUITING
Sofia
Canada
William Osler Health System-Brampton Civic Hospital|William Osler Health System
RECRUITING
Brampton
MUHC - Jewish General Hospital
RECRUITING
Montreal
Chile
FALP - Fundación Arturo López Pérez
RECRUITING
Providencia
Centro de Investigacion Clinica Bradford Hill
RECRUITING
Santiago
IRAM - Instituto de Radio Medicina
RECRUITING
Santiago
Oncocentro APYS
RECRUITING
Viña Del Mar
Croatia
General Hospital Dubrovnik
RECRUITING
Dubrovnik
General Hospital Pula
RECRUITING
Pula
Specialty Hospital Medico
RECRUITING
Rijeka
Department for Pulmonary Diseases University Hospital Centre Zagreb
RECRUITING
Zagreb
Sestre milosrdnice University Hospital Center
RECRUITING
Zagreb
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
France
CHU Angers - Hôpital Larrey
RECRUITING
Angers
Institut Sainte Catherine
RECRUITING
Avignon
Centre Hospitalier de la côte Basque
RECRUITING
Bayonne
Clinique Belharra
RECRUITING
Bayonne
Institut Bergonié
RECRUITING
Bordeaux
Hôpital Ambroise Paré
RECRUITING
Boulogne-billancourt
Centre Hospitalier Intercommunal de Creteil (CHIC)
RECRUITING
Créteil
Hopital Albert Calmette - CHU Lille
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Assistance Publique-Hôpitaux de Marseille
RECRUITING
Marseille
CH de Mulhouse - Hôpital Emile Muller
RECRUITING
Mulhouse
Hôpital Privé du Confluent
RECRUITING
Nantes
Hopital Saint Joseph - Paris
RECRUITING
Paris
Institut Curie
RECRUITING
Paris
CHU Rennes - Hopital Pontchaillou
RECRUITING
Rennes
ICO - Site René Gauducheau
RECRUITING
Saint-herblain
Hôpital Sainte Musse
RECRUITING
Toulon
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Vivantes Klinikum im Friedrichshain
RECRUITING
Berlin
Vivantes Klinikum Neukoelln
RECRUITING
Berlin
Vivantes Klinikum Spandau
RECRUITING
Berlin
Asklepios Klinik Harburg
RECRUITING
Hamburg
MHH Medizinische Hochschule Hannover
RECRUITING
Hanover
Greece
Alexandra General Hospital
RECRUITING
Athens
Henry Dunant Hospital Center
RECRUITING
Athens
University General Hospital Attikon
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Larissa
RECRUITING
Larissa
Bioclinic Thessaloniki
RECRUITING
Thessaloniki
Interbalkan Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Orszagos Koranyi Pulmonologiai Intezet
RECRUITING
Budapest
Bács-Kiskun County Hospital BKMK
RECRUITING
Kecskemét
Ireland
Beaumont Hospital
RECRUITING
Dublin
St James's Hospital
RECRUITING
Dublin
Italy
IRCCS Centro di Riferimento Oncologico
RECRUITING
Aviano
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Istituto di Candiolo
RECRUITING
Candiolo
Istituto Nazionale per la Ricerca sul Cancro di Genova
RECRUITING
Genova
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
RECRUITING
Meldola
IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
AOU Università degli Studi della Campania Luigi Vanvitelli
RECRUITING
Naples
AOU San Luigi Gonzaga
RECRUITING
Orbassano
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Regina Elena National Cancer Institute
RECRUITING
Roma
IRCCS Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano
CRC - Centro Ricerche Cliniche di Verona S.r.l.
RECRUITING
Verona
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Nippon Medical School Hospital
RECRUITING
Bunkyō City
National Cancer Center Hospital
RECRUITING
Chūōku
NHO Kyushu Cancer Center
RECRUITING
Fukuoka
Hiroshima University Hospital
RECRUITING
Hiroshima
NHO Hokkaido Cancer Center
RECRUITING
Hokkaido
JCHO Kyushu Hospital
RECRUITING
Kitakyushu-shi
Cancer Institute Hospital of JFCR
RECRUITING
Kōtō City
Saiseikai Kumamoto Hospital
RECRUITING
Kumamoto
Kurashiki Central Hospital
RECRUITING
Kurashiki-shi
Kurume University Hospital
RECRUITING
Kurume-shi
Shikoku Cancer Center
RECRUITING
Matsuyama
Aichi Cancer Center Hospital
RECRUITING
Nagoya
NHO Nagoya Medical Center
RECRUITING
Nagoya
Miyagi Cancer Center
RECRUITING
Natori-shi
Okayama University Hospital
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Osakasayama-shi
Gunma Prefectural Cancer Center
RECRUITING
Ota-shi
Kanagawa Cancer Center
RECRUITING
Yokohama
Netherlands
Amsterdam UMC Locatie VUMC
RECRUITING
Amsterdam
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
St. Jansdal Ziekenhuis
RECRUITING
Harderwijk
Zuyderland Medisch Centrum - Heerlen
RECRUITING
Heerlen
Leiden University Medical Center
RECRUITING
Leiden
Radboudumc
RECRUITING
Nijmegen
Erasmus Medisch Centrum
RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Isala Zwolle
RECRUITING
Zwolle
Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)
RECRUITING
Lodz
Aidport sp z o.o.
RECRUITING
Skorzewo
Instytut Gruzlicy i Chorob Pluc w Warszawie
RECRUITING
Warsaw
Maria Sklodowska-Curie National Research Institute of Oncology (Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie)
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Coimbra E P E
RECRUITING
Coimbra
Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Pan American Oncology Trials, LLC
RECRUITING
San Juan
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital
RECRUITING
Daegu
National Cancer Center Korea
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
ICO Girona
RECRUITING
Girona
ICO l'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Complejo Hospitalario Universitario Insular Materno-Infantil
RECRUITING
Las Palmas De Gran Canaria
Facility name: Clínica Universidad de Navarra
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
H.C. Hospitales S.L.
RECRUITING
Marbella
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Complejo Hospitalario Universitario de Santiago CHUS
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
IVO - Instituto Valenciano de Oncologia
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital Yunlin Branch
RECRUITING
Douliu
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Cancer Center
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital,Linkou
RECRUITING
Taoyuan
Turkey
Adana City Hospital
RECRUITING
Adana
Medical Park Seyhan Hospital
RECRUITING
Adana
Ankara City Hospital
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
RECRUITING
Istanbul
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
RECRUITING
Istanbul
İ.E.Ü. Medicalpoint İzmir Hastanesi
RECRUITING
Izmir
United Kingdom
Beatson West of Scotland Cancer Care
RECRUITING
Glasgow
Barts Hospital
RECRUITING
London
Guy's Hospital
RECRUITING
London
Nottingham University Hospitals City Campus
RECRUITING
Nottingham
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 702
Treatments
Experimental: 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).
Active_comparator: Arm B
Docetaxel, 75 mg/m\^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days).
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov

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