Phase
Condition
N/ATreatment
Pembrolizumab
Docetaxel
Acasunlimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participant has histologically or cytologically confirmed metastatic NSCLC (stage IVwith known subtype).
Participant has progressed radiographically on or after receiving:
One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapyconcomitantly) in the metastatic disease setting; OR
No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-basedchemotherapy sequentially, irrespective of the order) in the metastatic diseasesetting.
Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determinedprospectively on a tumor sample from the metastatic setting at a sponsor-designatedcentral laboratory.
Participant has measurable disease according to RECIST v1.1 as assessed by theinvestigator 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 testresults within 7 days of trial treatment.
Exclusion
Key Exclusion Criteria:
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 ratsarcoma 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 theydo not have access to approved targeted therapies.
Participants with newly identified or known unstable or symptomatic central nervoussystem (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 trialtreatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Centro de Investigacion Pergamino S.A.
Pergamino, Buenos Aires
ArgentinaActive - Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Ciudad Autonoma Buenos Aires
ArgentinaActive - Recruiting
Investigaciones CORI S.R.L.
La Rioja,
ArgentinaActive - Recruiting
Chris OBrien LifeHouse
Camperdown, New South Wales
AustraliaActive - Recruiting
Westmead Hospital
Sydney, New South Wales
AustraliaActive - Recruiting
Gold Coast Hospital
Southport, Queensland
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia
AustraliaActive - Recruiting
St Vincent's Hospital Melbourne
Fitzroy,
AustraliaActive - Recruiting
Ballarat Oncology & Haematology Service
Wendouree,
AustraliaActive - Recruiting
Kepler Universitatsklinikum Med Campus III
Linz,
AustriaActive - Recruiting
LKH - Rankweil
Rankweil,
AustriaActive - Recruiting
Cliniques Universitaires Saint-Luc
Brussels,
BelgiumActive - Recruiting
C. H. U. St-Pierre
Bruxelles,
BelgiumActive - Recruiting
Universitair Ziekenhuis Bruxelles
Bruxelles,
BelgiumActive - Recruiting
Grand Hôpital de Charleroi
Gilly,
BelgiumActive - Recruiting
Jessa Ziekenhuis Hospital
Hasselt,
BelgiumActive - Recruiting
AZ Sint-Maarten
Mechelen,
BelgiumActive - Recruiting
AZ Delta
Roeselare,
BelgiumActive - Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná
BrazilActive - Recruiting
MultiHemo Servicos Medicos
Recife, Pernambuco
BrazilActive - Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Su
BrazilActive - Recruiting
Hospital de Clinicas de Ijui
Ijuí, Rio Grande do Sul
BrazilActive - Recruiting
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, Rio Grande do Sul
BrazilActive - Recruiting
Instituto D'Or Pesquisa e Ensino - Rio de Janeiro
Rio de Janeiro, Rio do Janeiro
BrazilActive - Recruiting
BP A Beneficencia Portuguesa de Sao Paulo
São Paulo, Sao Paulo
BrazilActive - Recruiting
Centro Paulista de Oncologia S.A.
São Paulo, Sao Paulo
BrazilActive - Recruiting
Hospital Sirio-Libanes
São Paulo, Sao Paulo
BrazilActive - Recruiting
Oncoclínicas do Brasil Serviços Médicos SA
Belo Horizonte,
BrazilActive - Recruiting
Hospital Ernesto Dornelles
Porto Alegre,
BrazilActive - Recruiting
Oncoclínicas Rio de Janeiro
Rio de Janeiro,
BrazilActive - Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo Andre,
BrazilActive - Recruiting
MHAT Heart and Brain - Pleven
Pleven,
BulgariaActive - Recruiting
Complex Oncology Center - Plovdiv, EOOD
Plovdiv,
BulgariaActive - Recruiting
MHAT "Serdika", EOOD
Sofia,
BulgariaActive - Recruiting
MHAT for women's health - Nadezhda, OOD
Sofia,
BulgariaActive - Recruiting
UMHAT "Sv. Ivan Rilski", EAD
Sofia,
BulgariaActive - Recruiting
UMHAT 'SofiaMed', OOD
Sofia,
BulgariaActive - Recruiting
MUHC - Jewish General Hospital
Montreal, Quebec
CanadaActive - Recruiting
FALP - Fundación Arturo López Pérez
Providencia,
ChileActive - Recruiting
Centro de Investigacion Clinica Bradford Hill
Santiago,
ChileActive - Recruiting
IRAM - Instituto de Radio Medicina
Santiago,
ChileActive - Recruiting
Oncocentro APYS
Vina del Mar,
ChileActive - Recruiting
General Hospital Dubrovnik
Dubrovnik,
CroatiaActive - Recruiting
Specialty Hospital Medico
Rijeka,
CroatiaActive - Recruiting
Sestre milosrdnice University Hospital Center
Zagreb,
CroatiaActive - Recruiting
North Estonia Medical Centre Foundation
Tallinn,
EstoniaActive - Recruiting
Tartu University Hospital
Tartu,
EstoniaActive - Recruiting
Institut Bergonié
Bordeaux cedex, Gironde
FranceActive - Recruiting
Clinique Belharra
Bayonne, Pyrenees Atlantiques
FranceActive - Recruiting
Institut Sainte Catherine
Avignon Cedex 9, Vaculuse
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif cedex, Val de Marne
FranceActive - Recruiting
CHU Angers - Hôpital Larrey
Angers,
FranceActive - Recruiting
Centre Hospitalier de la côte Basque
Bayonne,
FranceActive - Recruiting
Hôpital Ambroise Paré
Boulogne Billancourt,
FranceActive - Recruiting
Centre Hospitalier Intercommunal de Creteil (CHIC)
Creteil Cedex,
FranceActive - Recruiting
Hopital Albert Calmette - CHU Lille
Lille Cedex,
FranceActive - Recruiting
Centre Léon Bérard
Lyon Cedex,
FranceActive - Recruiting
Assistance Publique-Hôpitaux de Marseille
Marseille,
FranceActive - Recruiting
CH de Mulhouse - Hôpital Emile Muller
Mulhouse,
FranceActive - Recruiting
Hôpital Privé du Confluent
Nantes,
FranceActive - Recruiting
Hopital Saint Joseph - Paris
Paris,
FranceActive - Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes,
FranceActive - Recruiting
ICO - Site René Gauducheau
Saint Herblain,
FranceActive - Recruiting
Hôpital Sainte Musse
Toulon,
FranceActive - Recruiting
Alexandra General Hospital
Athens,
GreeceActive - Recruiting
Henry Dunant Hospital Center
Athens,
GreeceActive - Recruiting
University General Hospital Attikon
Athens,
GreeceActive - Recruiting
University General Hospital of Heraklion
Heraklion,
GreeceActive - Recruiting
University General Hospital of Larissa
Larissa,
GreeceActive - Recruiting
Bioclinic Thessaloniki
Thessaloniki,
GreeceActive - Recruiting
Interbalkan Hospital of Thessaloniki
Thessaloniki,
GreeceActive - Recruiting
Beaumont Hospital
Dublin,
IrelandActive - Recruiting
St James's Hospital
Dublin,
IrelandActive - Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Milano
ItalyActive - Recruiting
Istituto Clinico Humanitas
Rozzano, Milano
ItalyActive - Recruiting
IRCCS Policlinico Universitario Agostino Gemelli
Rome, Roma
ItalyActive - Recruiting
AOU San Luigi Gonzaga
Orbassano, Torino
ItalyActive - Recruiting
Istituto di Candiolo
Candiolo,
ItalyActive - Recruiting
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova,
ItalyActive - Recruiting
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola,
ItalyActive - Recruiting
Ospedale Santa Maria delle Croci
Ravenna,
ItalyActive - Recruiting
Regina Elena National Cancer Institute
Roma,
ItalyActive - Recruiting
CRC - Centro Ricerche Cliniche di Verona S.r.l.
Verona,
ItalyActive - Recruiting
Shikoku Cancer Center
Matsuyama-shi, Ehime-Ken
JapanActive - Recruiting
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-Ken
JapanActive - Recruiting
Saiseikai Kumamoto Hospital
Kumamoto-shi, Kumamoto-Ken
JapanActive - Recruiting
Kindai University Hospital
Osakasayama-shi, Osaka-Fu
JapanActive - Recruiting
Juntendo University Hospital
Bunkyō-Ku, Tokyo-To
JapanActive - Recruiting
Nippon Medical School Hospital
Bunkyo-ku,
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku,
JapanActive - Recruiting
NHO Kyushu Cancer Center
Fukuoka-shi,
JapanActive - Recruiting
NHO Hokkaido Cancer Center
Hokkaido,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Koto City,
JapanActive - Recruiting
Kurashiki Central Hospital
Kurashiki-shi,
JapanActive - Recruiting
Kurume University Hospital
Kurume-shi,
JapanActive - Recruiting
NHO Nagoya Medical Center
Nagoya,
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya-shi,
JapanActive - Recruiting
Miyagi Cancer Center
Natori-shi,
JapanActive - Recruiting
Okayama University Hospital
Okayama,
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Osaka,
JapanActive - Recruiting
Osaka International Cancer Institute
Osaka-shi,
JapanActive - Recruiting
Gunma Prefectural Cancer Center
Ota-shi,
JapanActive - Recruiting
Kanagawa Cancer Center
Yokohama-shi,
JapanActive - Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital
Cheongju-si,
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital
Chungcheongbuk-do,
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Daegu,
Korea, Republic ofActive - Recruiting
National Cancer Center Korea
Goyang-si,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
Amsterdam UMC Locatie VUMC
Amsterdam,
NetherlandsActive - Recruiting
Antoni van Leeuwenhoek
Amsterdam,
NetherlandsActive - Recruiting
St. Jansdal Ziekenhuis
Harderwijk,
NetherlandsActive - Recruiting
Leiden University Medical Center
Leiden,
NetherlandsActive - Recruiting
Radboudumc
Nijmegen,
NetherlandsActive - Recruiting
Erasmus Medisch Centrum
Rotterdam,
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht
Utrecht,
NetherlandsActive - Recruiting
Isala Zwolle
Zwolle,
NetherlandsActive - Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow,
PolandActive - Recruiting
Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)
Lodz,
PolandActive - Recruiting
Aidport sp z o.o.
Skorzewo,
PolandActive - Recruiting
Instytut Gruzlicy i Chorob Pluc w Warszawie
Warszawa,
PolandActive - Recruiting
Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
Matosinhos,
PortugalActive - Recruiting
Auxilio Mutuo Cancer Center
San Juan, 917
Puerto RicoActive - Recruiting
Pan American Oncology Trials, LLC
San Juan, 902
Puerto RicoActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba, Córdoba
SpainActive - Recruiting
Complejo Hospitalario Universitario de Santiago CHUS
Santiago de Compostela, La Coruña
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid
SpainActive - Recruiting
H.C. Hospitales S.L.
Marbella, Málaga
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, Navarra
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona,
SpainActive - Recruiting
ICO Girona
Girona,
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid,
SpainActive - Recruiting
Hospital Quironsalud Malaga
Malaga,
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Sevilla,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia,
SpainActive - Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu,
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan,
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei,
TaiwanActive - Recruiting
Chang Gung Memorial Hospital,Linkou
Taoyuan City,
TaiwanActive - Recruiting
Medical Park Seyhan Hospital
Adana,
TurkeyActive - Recruiting
İ.E.Ü. Medicalpoint İzmir Hastanesi
Izmir,
TurkeyActive - Recruiting
Barts Hospital
London,
United KingdomActive - Recruiting
Guy's Hospital
London,
United KingdomActive - Recruiting
Nottingham University Hospitals City Campus
Nottingham,
United KingdomActive - Recruiting
Derriford Hospital
Plymouth,
United KingdomActive - Recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90089
United StatesActive - Recruiting
Kaiser Permanente Vallejo Medical Center
Vallejo, California 94589
United StatesActive - Recruiting
Ocala Oncology Center P.L.
Ocala, Florida 34474
United StatesActive - Recruiting
Orlando Regional Medical Center
Orlando, Florida 32806
United StatesActive - Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia 30607
United StatesActive - Recruiting
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
Atlanta, Georgia 30328
United StatesActive - Recruiting
Piedmont Cancer Institute Atlanta
Atlanta, Georgia 30318
United StatesActive - Recruiting
Piedmont Cancer Institute - Fayetteville Office
Fayetteville, Georgia 30214
United StatesActive - Recruiting
Piedmont Cancer Institute - Newnan Office
Newnan, Georgia 30265
United StatesActive - Recruiting
Piedmont Cancer Institute - Stockbridge Office
Stockbridge, Georgia 30281
United StatesActive - Recruiting
Kaiser Foundation Hospitals
Honolulu, Hawaii 96817
United StatesActive - Recruiting
University of Illinois
Chicago, Illinois 60612
United StatesActive - Recruiting
Community Cancer Center East Medical Oncology Hematology
Indianapolis, Indiana 46219
United StatesActive - Recruiting
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40202
United StatesActive - Recruiting
Pikeville Medical Center
Pikeville, Kentucky 41501
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
St. Francis Hospital - Grand Island
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Oncology Hematology West
Omaha, Nebraska 68124
United StatesActive - Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting
University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Parkridge Medical Center
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Midtown Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37205
United StatesActive - Recruiting
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