A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
FRAmework-01
FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
6 other identifiers
interventional
1,080
25 countries
249
Brief Summary
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
Longer than P75 for phase_3
249 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 7, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
October 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
May 27, 2026
May 1, 2026
2.4 years
October 7, 2025
May 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Randomization to radiographic progression or death from any cause (up to 70 months)
Secondary Outcomes (12)
Overall Survival (OS)
Randomization to date of death from any cause (up to 70 months)
PFS
Randomization to radiographic progression or death from any cause (up to 70 months)
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Randomization to disease progression or death (up to 70 months)
Duration of Response (DOR)
Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Randomization to disease progression or death from any cause (up to 70 months)
- +7 more secondary outcomes
Study Arms (4)
Part A: Sofetabart Mipitecan
EXPERIMENTALAdministered intravenously (IV).
Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)
ACTIVE COMPARATORInvestigator's Choice of Chemotherapy or MIRV given IV.
Part B: LY4170156 plus Bevacizumab
EXPERIMENTALAdministered IV.
Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab
ACTIVE COMPARATORInvestigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Interventions
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Eligibility Criteria
You may qualify if:
- Part A and B:
- Have histologically confirmed high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
- Have confirmed availability of tumor tissue block or slides
- Have radiographic progression on or after most recent line of systemic anticancer therapy
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Have measurable disease per RECIST v1.1
- Part A:
- Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
- Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine.
- Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
- Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.
- Part B:
- Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy
- Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy
- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.
You may not qualify if:
- Part A and B:
- \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.
- Part A:
- \- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.
- Part B:
- \- Have clinically significant proteinuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- GOG Foundationcollaborator
- Asia-Pacific Gynecologic Oncology Trials Groupcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (259)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
HonorHealth
Phoenix, Arizona, 85016, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, 91505, United States
City of Hope, Duarte
Duarte, California, 91010, United States
Moores Cancer Center
La Jolla, California, 92093, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, 90095, United States
Stanford Women's Cancer Center
Palo Alto, California, 94305, United States
Kaiser Permanente Zion Medical Center
San Diego, California, 92120, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Kaiser Permanente
Vallejo, California, 94589, United States
Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
AdventHealth Medical Group - Porter
Denver, Colorado, 80210, United States
UConn Health
Farmington, Connecticut, 06030-8010, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Florida Cancer Specialist- South
Fort Myers, Florida, 33901, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialist- East
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Nancy N. & J.C. Lewis Cancer and Research Pavillion
Savannah, Georgia, 31405, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Medicine
Chicago, Illinois, 60637, United States
OSF Saint Fracis Medical Center
Peoria, Illinois, 61637, United States
Franciscan Health
Indianapolis, Indiana, 46237, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Trials 365
Shreveport, Louisiana, 71103, United States
Maine Medical Center - Scarborough Campus
Scarborough, Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
University of Missouri Hospital
Columbia, Missouri, 65212, United States
HCA Midwest Kansas City, MidAmerica Division, Inc.
Kansas City, Missouri, 64132, United States
Cox Medical Center North
Springfield, Missouri, 65802, United States
The Center of Hope
Reno, Nevada, 89511, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Optimum Clinical Research Group
Albuquerque, New Mexico, 87109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042, 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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon, 97401, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
USO-Texas Oncology-Central/South Texas
Austin, Texas, 78731, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
US Oncology
The Woodlands, Texas, 77380, United States
US Oncology
The Woodlands, Texas, 77380, United States
USO - Texas Oncology Gulf Coast
Webster, Texas, 77598-4420, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Ballarat Health Services
Ballarat Central, 3350, Australia
Chris O'Brien Lifehouse
Camperdown, 2050, Australia
Launceston General Hospital
Launceston, 7250, Australia
Cabrini Hospital - Malvern
Malvern, 3144, Australia
Prince of Wales Hospital
Randwick, 2031, Australia
Goulburn Valley Health
Shepparton, 3630, Australia
Gold Coast University Hospital
Southport, 4215, Australia
Royal North Shore Hospital
St Leonards, 2065, Australia
The Townsville Hospital
Townsville, 4814, Australia
Latrobe Regional Health
Traralgon, 3844, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CPAM - Centro de Pesquisas da Amazônia
Belém, 66063-495, Brazil
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina
Florianópolis, 88020-210, Brazil
Hospital Brasilia
Lago Sul, 71635580, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905, Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22271-110, Brazil
Clinica Amo - Rio Vermelho
Salvador, 41950-640, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, 09541-270, Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, T2N 5G2, Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, L8V5C2, Canada
Jewish General Hospital
Montreal, H3T 1E2, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie Centre Hospitalier Universitaire -T
Sherbrooke, J1H 5N4, Canada
BC Cancer Surrey
Surrey, V3V 0E8, Canada
Sunnybrook Research Institute
Toronto, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, M5G 2M9, Canada
Peking University First Hospital
Beijing, 100032, China
Beijing Cancer hospital
Beijing, 100142, China
The First Hospital of Jilin University
Changchun, 130021, China
The First People's Hospital of Changde City
Changde, 415003, China
Xiangya Hospital Central South University
Changsha, 410008, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120, China
Zhujiang Hospital
Guangzhou, 510280, China
Sun Yat-Sen University Cancer Centre
Guangzhou, 511400, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shandong Cancer Hospital
Jinan, 250117, China
Gansu Provincial Maternity and Child Care Hospital
Lanzhou, 730050, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471023, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210000, China
Jiangsu Province Hospital
Nanjing, 210029, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200011; 200090, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Cancer Hospital of Shantou University Medical College
Shantou, 515031, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Wuhan Union Hospital
Wuhan, 430022, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030, China
Fakultní Nemocnice Brno
Brno, 602 00, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jiín, 741 01, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Nemocnice Tomase Bati ve Zline
Zlín, 762 75, Czechia
Rigshospitalet
Copenhagen, 2100, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Institut de Cancérologie de l'Ouest
Angers, 49055, France
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076, France
CHRU de Brest
Brest, 29609, France
Centre Oscar Lambret
Lille, 59020, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon Cedex08, 69373, France
Institut Régional du Cancer Montpellier
Montpellier, 34298, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
CHU Strasbourg-Hautepierre
Strasbourg, 67098, France
Universitätsklinikum Aachen
Aachen, 52074, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
Alexandra Hospital
Athens, 115 28, Greece
Aretaieio Hospital
Athens, 115 28, Greece
General Hospital of Kalamata
Kalamata, 241 00, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, 145 64, Greece
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024, Hungary
Cork University Hospital
Cork, T12 DC4A, Ireland
St. Vincent's University Hospital
Dublin, D04 T6F4, Ireland
St. James's Hospital
Dublin, D08 E9P6, Ireland
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Ospedale Cannizzaro
Catania, 95126, Italy
Ospedale Vito Fazzi
Lecce, 73100, Italy
Azienda USL 2 Lucca
Lucca, 55100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Ospedale Humanitas San Pio X
Milan, 20159, Italy
Azienda Ospedaliero Universitaria
Modena, 41125, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131, Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, 59100, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Hyogo Cancer Center
Akashi, 673-8558, Japan
National Cancer Center Hospital
Chūōku, 104-0045, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Gunma Prefectural Cancer Center
Otashi, 373-8550, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, 028-3695, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Ehime University Hospital
Tōon, 791-0295, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, 03100, Mexico
Higiea Oncologia
Mexico City, 11819, Mexico
INCAN
Mexico City, 14080, Mexico
Unidad Médica Onco-hematológica
Puebla City, 72424, Mexico
Hospital Angeles
Tijuana, 22010, Mexico
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379, Norway
Stavanger Universitetssykehus
Stavanger, 4011, Norway
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
Poznan, 61-866, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach
Siedlce, 08-110, Poland
SC Memorial Healthcare International SRL
Bucharest, 013812, Romania
Sc Mnt Healthcare Europe Srl
Bucharest, 013975, Romania
Institutul Regional de Oncologie
Iași, 700483, Romania
S C Oncocenter Oncologie Clinica S R L
Timișoara, 300166, Romania
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Provincial Centre de Castelló
Castellon, 12002, Spain
Hospital Universitario Virgen Nieves
Granada, 18012, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, 28702, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706, Spain
Hospital Universitario de Toledo
Toledo, 45007, Spain
Kantonsspital Baden
Baden, 5404, Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500, Switzerland
Kantonsspital Graubünden
Chur, 7000, Switzerland
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211, Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Royal United Hospitals NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Marsden Hospital (Sutton)
London, SM2 5PT, United Kingdom
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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 7, 2025
First Posted
October 9, 2025
Study Start
October 22, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
August 1, 2031
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should 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.