A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
CYCLONE 3
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
3 other identifiers
interventional
925
24 countries
266
Brief Summary
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2022
Longer than P75 for phase_3
266 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
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2024
CompletedResults Posted
Study results publicly available
June 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedJune 27, 2025
June 1, 2025
1.8 years
March 10, 2022
February 13, 2025
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.
From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)
Secondary Outcomes (7)
Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR)
From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)
Castration-resistant Prostate Cancer (CRPC)-Free Survival
Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 ng/dL; or death from any cause (up to 22 months)
Overall Survival (OS)
From Date of Randomization to Date of Death Due to Any Cause (Up to 22 Months)
Time to Pain Progression
Randomization to pain progression (up to 22 months)
Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Physical Well-Being Subscale
Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)
- +2 more secondary outcomes
Study Arms (2)
Abemaciclib
EXPERIMENTALParticipants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
Placebo
ACTIVE COMPARATORParticipants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
Interventions
Eligibility Criteria
You may qualify if:
- Adenocarcinoma of the prostate (as the predominant histology)
- High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:
- Greater than or equal to (≥)4 bone metastases by bone scan and/or
- ≥1 visceral metastases by computed tomography or magnetic resonance imaging
- Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You may not qualify if:
- Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor
- Development of metastatic prostate cancer in the context of castrate levels of testosterone
- Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
- Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
- History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
- Uncontrolled hypertension
- Clinically active or chronic liver disease, moderate/severe hepatic impairment
- Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (266)
Arizona Oncology Associates, P.C. - HOPE
Prescott, Arizona, 86301, United States
Arizona Oncology Associates, P.C. - HOPE
Prescott Valley, Arizona, 86314, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719, United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, 71913, United States
St. Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Moores Cancer Center
La Jolla, California, 92093, United States
MemorialCare Health System - Long Beach Medical Center
Long Beach, California, 90806, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404, United States
Torrance Memorial Physician Network / Cancer Care
Torrance, California, 90505, United States
PIH Health Hematology Medical Oncology
Whittier, California, 90602, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital
Colorado Springs, Colorado, 80909, United States
UCHealth Harmony
Fort Collins, Colorado, 80528, United States
Colorado West Healthcare System - Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
USO-Rocky Mountain Cancer Center
Littleton, Colorado, 80120, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Millennium Oncology Research Clinic
Hollywood, Florida, 33024, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136, United States
Florida Cancer Specialist- East
West Palm Beach, Florida, 33401, United States
Dwight D Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Summit Cancer Care DBA Candler Medical Oncology Practice
Savannah, Georgia, 31405, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
The University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Sarah Cannon Research Institute
Baton Rouge, Louisiana, 70809, United States
Chesapeake Urology
Towson, Maryland, 21204, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Reliant Medical Group
Worcester, Massachusetts, 01606, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, 55404, United States
Care Access - Clifton
Clifton, New Jersey, 07013, United States
Maimonides Cancer Center
Brooklyn, New York, 11220, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
Associated Medical Professionals - Urology
Syracuse, New York, 13210, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
TriState Urologic Services PSC Inc.
Cincinnati, Ohio, 45212, United States
Northwest Cancer Specialist
Tigard, Oregon, 97223, United States
MidLantic urology
Bala-Cynwyd, Pennsylvania, 19004, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Tennessee Oncology Chattanooga-SCRI
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology - Balcones
Austin, Texas, 78731, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology - Carrollton
Flower Mound, Texas, 75028, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, 77479, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
US Oncology Research Network
The Woodlands, Texas, 77380, United States
Texas Oncology - Longview Cancer Center
Tyler, Texas, 75702, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05405, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, 24014, United States
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Investigaciones Clinicas Moleculares (ICM)
Buenos Aires, Buenos Aires F.D., 1425, Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, Buenos Air, C1419AHN, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP, Argentina
Fundación Cenit Para La Investigación En Neurociencias
CABA, Ciudad Autónoma de Buenos Aire, 1125, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, X5008HHW, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, 5800, Argentina
Clinica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro Oncologico Korben
Buenos Aires, 1426, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Centro Urológico Profesor Bengió
Córdoba, 5000, Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Macquarie University
Macquarie University, New South Wales, 2109, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101, Australia
Tasman Oncology Research
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
Epworth Freemasons
Richmond, Victoria, 3121, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, 9300, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, West-Vlaanderen, 8500, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, Ceará, 60430230, Brazil
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-070, Brazil
Centro Avançado de Tratamento Oncológico- CENANTRON
Belo Horizonte, Minas Gerais, 30130090, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810050, Brazil
Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400, Brazil
Instituto de de Educação, pesquisa e Gestão em Saúde
Rio de Janeiro, 22775-001, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, 01221-020, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, 04014-002, Brazil
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Second Affiliated hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, 241001, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Sun Yat-Sen University Cancer Centre
Guangzhou, Guangdong, 510060, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 132000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Nanchong Central Hospital
Nanchong, Sichuan, 637000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300020, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Nemocnice Horovice
Hořovice, Beroun, 268 31, Czechia
Masarykuv onkologicky ustav
Brno, Brno-město, 656 53, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, 10034, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
Oblastni nemocnice Pribram
Příbram, Příbram, 261 01, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, South Moravian, 656 91, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Urocentrum Praha
Prague, 120 00, Czechia
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69373, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, 29200, France
Polyclinique De Blois
La Chaussée-Saint-Victor, Centre-Val de Loire, 41260, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079, France
CHU Besançon
Besançon, Doubs, 25000, France
Centre de Cancérologie du Grand Montpellier
Montpellier, Languedoc-Roussillon, 34070, France
Hôpital privé du Confluent SAS
Nantes, Loire-Atlantique, 44277, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-Atlantique, 44805, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
Clinique Victor Hugo Le Mans
Le Mans, Sarthe, 72000, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
NCT
Heidelberg, Baden-Wurttemberg, 69120, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Würt, 72076, Germany
Klinikum Rechts Der Isar Der Technischen Universität München
Munich, Bavaria, 81675, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Urologicum Duisburg Fachärztesozietät - Walsum
Duisburg, North Rhine-Westphalia, 47169, Germany
Urologische Gemeinschaftspraxis Heinsberg
Heinsberg, North Rhine-Westphalia, 52525, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 48149, Germany
Urologische Gemeinschaftspraxis Wesel
Wesel, North Rhine-Westphalia, 46483, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, 56068, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Urologie Neandertal - Praxis Mettmann
Mettmann, 40822, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
University Hospital of Patras
Pátrai, Achaḯa, 26504, Greece
Agios Savvas Regional Cancer Hospital
Athens, Attikí, 115 22, Greece
Alexandra Hospital
Athens, Attikí, 115 28, Greece
Attikon General University Hospital
Chaïdári, Attikí, 12462, Greece
University General Hospital of Heraklion
Heraklion, Irakleío, 711 10, Greece
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, 6000, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, 9024, Hungary
Országos Onkológiai Intézet
Budapest, Pest County, 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
Meir Medical Center
Kfar Saba, Central District, 4428164, Israel
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Yitzhak Shamir Medical Center
Ẕerifin, Central District, 70300, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Rambam Health Care Campus
Haifa, Northern District, 3109601, Israel
Sourasky Medical Center
Tel Aviv, Tell Abīb, 6423906, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Emilia-Romagna, 47014, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Veneto, 31033, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Azienda Ospedaliera Santa Maria Terni
Terni, 05100, Italy
APSS- Presidio Ospedaliero S. Chiara
Trento, 38122, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kimitsu Chuo Hospital
Kisarazu, Chiba, 292-8535, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-0841, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa University Hospital
Kita, Kagawa-ken, 761-0701, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Nagano Municipal Hospital
Tomitake, Nagano, 381-8551, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Showa University Hospital
Shinagawa, Tokyo, 142-8555, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, 44680, Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, Mexico City, 03100, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, 80230, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
ETZ Elisabeth
Tilburg, North Brabant, 5022 GC, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Clinical Best Solutions
Lublin, Lublin Voivodeship, 20-011, Poland
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
Opole, Opole Voivodeship, 45-061, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Salve Medica
Lodz, Łódź Voivodeship, 91-211, Poland
Provita Profamilia
Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283, Romania
Amethyst Radiotherapy Center
Florești, Cluj, 407280, Romania
Ovidius Clinical Hospital OCH
Ovidiu, Constanța County, 905900, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542, Romania
Radiology Therapeutic Center
Otopeni, Ilfov, 075100, Romania
Oncopremium Team
Baia Mare, Maramureş, 430291, Romania
SC Memorial Healthcare International SRL
Bucharest, 013812, Romania
Gral Medical Diagnostic Center
Bucharest, 031422, Romania
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, Barcelona [Barcelona], 08907, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, 46009, Spain
Hospital Infanta Cristina
Badajoz, 06006, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
National Taiwan University Hospital
Taipei City, Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei City, Taipei, 11217, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Medipol Mega Universite Hastanesi
Stanbul, Istanbul, 34214, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, Karsiyaka, İzmir, 009035575, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21200, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
Royal Blackburn Hospital
Blackburn, Blackburn With Darwen, BB2 3HH, United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL, United Kingdom
University College London Hospital
London, London, City of, NW1 2PG, United Kingdom
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 21, 2022
Study Start
April 14, 2022
Primary Completion
February 15, 2024
Study Completion (Estimated)
October 1, 2027
Last Updated
June 27, 2025
Results First Posted
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.