Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
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)
5 other identifiers
interventional
191
25 countries
241
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2024
Typical duration for phase_3
241 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedStudy Start
First participant enrolled
November 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
May 5, 2026
May 1, 2026
2.7 years
October 8, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 5 years
Secondary Outcomes (9)
Progression-Free Survival (PFS)
Up to approximately 5 years
Confirmed Overall Response Rate (ORR)
Up to approximately 5 years
Duration of Response (DOR)
Up to approximately 5 years
Number of Participants With Adverse Events (AEs)
From first dose until the end of the study (approximately 5 years)
Time to Treatment Discontinuation Due to AE
From first dose until the end of the study (approximately 5 years)
- +4 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALAcasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days).
Arm B
ACTIVE COMPARATORDocetaxel, 75 mg/m\^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days).
Interventions
Eligibility Criteria
You may qualify if:
- Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or 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 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.
- 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.
- 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.
You may not qualify if:
- 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.
- Participants with newly identified, untreated or unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
- Prior treatment with docetaxel for NSCLC.
- Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
- Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
Study Sites (247)
Arizona Blood and Cancer Specialists
Tucson, Arizona, 85712, United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90089, United States
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589, United States
Ocala Oncology Center P.L.
Ocala, Florida, 34474, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Piedmont Cancer Institute Atlanta
Atlanta, Georgia, 30318, United States
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
Atlanta, Georgia, 30328, United States
Piedmont Cancer Institute - Fayetteville Office
Fayetteville, Georgia, 30214, United States
Piedmont Cancer Institute - Newnan Office
Newnan, Georgia, 30265, United States
Piedmont Cancer Institute - Stockbridge Office
Stockbridge, Georgia, 30281, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96817, United States
University of Illinois
Chicago, Illinois, 60612, United States
Community Cancer Center East Medical Oncology Hematology
Indianapolis, Indiana, 46219, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Pikeville Medical Center
Pikeville, Kentucky, 41501, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Francis Hospital - Grand Island
Grand Island, Nebraska, 68803, United States
Oncology Hematology West
Omaha, Nebraska, 68124, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Stony Brook University Medical Center|University Medical Center
Stony Brook, New York, 11790, United States
Novant Health Pharmacy
Charlotte, North Carolina, 28204, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, 37920, United States
Midtown Tennessee Oncology
Nashville, Tennessee, 37203, United States
Tennessee Oncology
Nashville, Tennessee, 37205, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology-Austin Central
Austin, Texas, 78731, United States
South Austin Cancer Ctr
Austin, Texas, 78745, United States
University of Virginia Hematology and Oncology
Charlottesville, Virginia, 22903, United States
Cancer Institute At Swedish Med Ctr
Seattle, Washington, 98104, 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, 902, Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, 917, 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 City, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Official
Genmab
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 10, 2024
Study Start
November 25, 2024
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
September 30, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share