A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
3 other identifiers
interventional
920
18 countries
317
Brief Summary
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Longer than P75 for phase_3
317 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
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 15, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2033
April 29, 2026
April 1, 2026
3.4 years
September 12, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
Investigator-assessed
Baseline to objective progression or death due to any cause (Estimated up to 5 years)
Secondary Outcomes (15)
(Part 1): Disease Control Rate (DCR)
Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
(Parts 1 and 2): Duration of Response (DOR)
Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
(Part 1): PFS
Baseline to objective progression or death due to any cause (Estimated up to 5 years)
(Parts 1 and 2): Overall Survival (OS)
Baseline to deaths from any cause (Estimated up to 7 years)
- +10 more secondary outcomes
Study Arms (3)
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1)
EXPERIMENTALLY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)
EXPERIMENTALLY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)
PLACEBO COMPARATORPlacebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Interventions
Administered orally
Administered orally
Administered orally
Administered orally
Administered orally
Administered intramuscular
Administered orally
Eligibility Criteria
You may qualify if:
- Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.
- If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
- Have histologically or cytologically confirmed breast cancer, defined as individuals with
- locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
- hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines
- HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
- HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines
- Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
- Have measurable disease or non-measurable, evaluable bone disease
- Part 1:
- Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
- Up to 1 of these prior systemic treatments may contain chemotherapy
- Part 2:
- Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.
- +7 more criteria
You may not qualify if:
- Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \[mmol/L\]), or requiring insulin.
- Have inflammatory or metaplastic breast cancer.
- History of leptomeningeal disease or carcinomatous meningitis.
- Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
- Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
- Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \[mg\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
- Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Pfizercollaborator
Study Sites (317)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054, 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
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
City of Hope
Duarte, California, 91010, United States
Marin Cancer Care
Greenbrae, California, 94904, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine
Irvine, California, 92612, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
Moores Cancer Center
La Jolla, California, 92093, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Kaiser Permanente Oakland
Oakland, California, 94611, United States
Profound Research LLC
Oceanside, California, 92056, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
Kaiser Permanente
Roseville, California, 95661, United States
Kaiser Permanente
San Francisco, California, 94115, United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
Kaiser Permanente
Santa Clara, California, 95051, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, 90404, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Kaiser Permanente
Vallejo, California, 94589, United States
Kaiser Permanente Walnut Creek
Walnut Creek, California, 94596, United States
Cancer Centers of Colorado St. Mary's Regional Hospital
Grand Junction, Colorado, 81501, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631, United States
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, 80538, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701, United States
Clermont Oncology Center
Clermont, Florida, 34711, United States
Florida Oncology & Hematology
Fort Myers, Florida, 33912, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Central Georgia Cancer Care
Macon, Georgia, 31210, United States
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265, United States
Summit Cancer Care, PC
Savannah, Georgia, 31405, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
City of Hope, Chicago
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Accellacare of Duly
Lisle, Illinois, 60532, United States
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Deaconess Chancellor Center for Oncology
Newburgh, Indiana, 47630, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Saint Elizabeth Medical Center Edgewood
Edgewood, Kentucky, 41017, United States
Our Lady of the Lake RMC
Baton Rouge, Louisiana, 70808, United States
New England Cancer Specialists
Westbrook, Maine, 04092, United States
American Oncology Partners, PA
Bethesda, Maryland, 20817, United States
James M Stockman Cancer Institute
Frederick, Maryland, 21702, United States
Mass General Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center - South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Profound Research LLC
Sterling Heights, Michigan, 48314, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Oncology Hematology Associates
Springfield, Missouri, 65807, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, 08002, United States
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, 08080, United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Messino Cancer Centers
Asheville, North Carolina, 28806, United States
WakeMed Cancer Care - Waverly Hematology & Medical Oncology
Cary, North Carolina, 27518, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
Carolina Cancer Research Center
Wilson, North Carolina, 27893, United States
Cleveland Clinic Akron General
Akron, Ohio, 44302, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Fairview Hospital
Cleveland, Ohio, 44111, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330, United States
Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107, United States
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203, United States
Nashville General Hospital
Nashville, Tennessee, 37208, United States
Hendrick Medical Center
Abilene, Texas, 79601, United States
World Research Link
Baytown, Texas, 77521, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
USO - Texas Oncology
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology - West Texas
El Paso, Texas, 79902, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Oncology Consultants P.A.
Houston, Texas, 77030, United States
Nova Oncology
McAllen, Texas, 78504, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240, United States
US Oncology Research Network
The Woodlands, Texas, 77380, United States
Tranquility Research
Webster, Texas, 77598, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
UW Medicine Valley Medical Center
Renton, Washington, 98055, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Deaconess Hospital
Spokane, Washington, 99204, United States
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
North Star Lodge
Yakima, Washington, 98902, United States
ThedaCare Physicians - Appleton North
Appleton, Wisconsin, 54911, United States
CIPREC
Buenos Aires, 1061, Argentina
Investigaciones Clinicas Moleculares (ICM)
Buenos Aires, 1425, Argentina
Centro Oncologico Korben
Buenos Aires, 1426, Argentina
Hospital Medico Policial Churruca-Visca
Buenos Aires, 1437, Argentina
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Fundación Innovaciencia
Rosario, 2000, Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS, Argentina
COE (Centro Oncológico de Excelencia)
San Juan, 5400, Argentina
Instituto San Marcos
San Juan, 5400, Argentina
Go Centro Medico San Nicolás
San Nicolás, 2900, Argentina
Ballarat Health Services
Ballarat Central, 3350, Australia
The Prince Charles Hospital
Brisbane, 4032, Australia
St Vincent's Hospital
Darlinghurst, 2010, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Lake Macquarie Private Hospital
Newcastle, 2290, Australia
Macquarie University
North Ryde, 2109, Australia
Goulburn Valley Health
Shepparton, 3630, Australia
St. John of God Subiaco Hospital
Subiaco, 6008, Australia
The Townsville Hospital
Townsville, 4814, Australia
Institut Jules Bordet
Anderlecht, 1070, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
AZ Nikolaas
Sint-Niklaas, B-9100, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400, Brazil
Hospital São Domingos
Bequimão, 65060-645, Brazil
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430235, Brazil
Hospital Araújo Jorge
Goiânia, 74605070, Brazil
Hospital Brasilia
Lago Sul, 71635580, Brazil
Hospital de Cancer de Londrina
Londrina, 86015-520, Brazil
Instituto Atena de Pesquisa Clinica - Mossoró
Mossoró, 59603-020, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, 59062-000, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905, 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
Hospital Santa Catarina - Paulista
São Paulo, 01310-000, Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, 01317-000, Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002, Brazil
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, L8V5C2, Canada
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
Québec, G1S 4L8, Canada
Princess Margaret Cancer Centre
Toronto, M5G 2M9, Canada
Anyang Cancer Hospital
Anyang, 455000, 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
Deyang City People's Hospital
Deyang, 618099, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, 510060, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangmen Center Hospital
Jiangmen, China
The first affiliated hospital of Ningbo university
Ningbo, 315010, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Cancer Hospital of Shantou University Medical College
Shantou, 515031, China
The First Hospital of China Medical University
Shenyang, 110001, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030, China
Central Hospital of Guangdong Provincial Agricutural Reclamation
Zhanjiang, 524002, China
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918, France
CHU Besançon
Besançon, 25000, France
CHRU de Brest
Brest, 29609, France
Clinique Victor Hugo Le Mans
Le Mans, 72000, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Centre de Cancérologie du Grand Montpellier
Montpellier, 34070, France
Institut Curie
Paris, 75248, France
Institut Jean Godinot
Reims, 51726, France
Institut Curie - site Saint-Cloud
Saint-Cloud, 92210, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
Oncopole Claudius Regaud
Toulouse, 31059, France
Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54519, France
Gustave Roussy
Villejuif, 94800, France
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117, Germany
Marienhospital Bottrop
Bottrop, 46236, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Städtisches Klinikum Dessau
Dessau, 06847, Germany
Onkologiezentrum Donauwörth
Donauwörth, 86609, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
MVZ Medical Center Düsseldorf GmbH
Düsseldorf, 40235, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, 45136, Germany
Agaplesion Markus Krankenhaus
Frankfurt, 60431, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
Friedrichshafen, 88045, Germany
OSP Göttingen
Göttingen, 37073, Germany
Mammazentrum HH - Krankenhaus Jerusalem
Hamburg, 20357, Germany
Universitaetsklinikum des Saarlandes
Homburg, 66424, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, 80336, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
SRH Zentralklinikum Suhl
Suhl, 98527, Germany
Helios HSK Wiesbaden
Wiesbaden, 65199, Germany
Marien Hospital Witten
Witten, 58452, Germany
HELIOS Klinikum Wuppertal
Wuppertal, 42283, Germany
Agios Savvas Regional Cancer Hospital
Athens, 115 22, Greece
Aretaieio Hospital
Athens, 115 28, Greece
Attikon General University Hospital
Chaïdári, 12462, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
University Hospital of Ioannina
Ioannina, 455 00, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26504, Greece
European Interbalkan Medical Center
Thessaloniki, 54639, Greece
European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
St. Vincent's University Hospital
Dublin, D04 T6F4, Ireland
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Ospedale San Martino
Genova, 16132, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, 95045, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Chiba cancer center
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukushima Medical University
Fukushima, 960-1295, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Sagara Hospital
Kagoshima, 892-0833, Japan
Kanazawa Medical University Hospital
Kahoku-gun, 920-0293, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
Nakagami Hospital
Okinawa, 904-2142, Japan
Gunma Prefectural Cancer Center
Otashi, 373-8550, Japan
Saitama Red Cross Hospital
Saitama, 330-8553, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Showa Medical University Hospital
Shinagawa City, 142-8666, Japan
Shizuoka General Hospital
Shizuoka, 420-8527, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Tsukuba University Hospital
Tsukuba, 305-8576, Japan
Kanagawa cancer center
Yokohama, 2418515, Japan
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, 31151, South Korea
Kyungpook National University Chilgok Hospital
Deagu, 41404, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Korea University Anam Hospital
Seoul, 02841, 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
Hospital Infanta Cristina
Badajoz, 06006, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, 08907, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hospital Beata María Ana
Madrid, 28007, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Fundación Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clinico de Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250, Turkey (Türkiye)
Adana City Hospital
Adana, 01370, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, 06200, Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, 06620, Turkey (Türkiye)
Ege Universitesi Hastanesi
Bornova, 35100, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Koç Üniversitesi Hastanesi
Istanbul, 34010, Turkey (Türkiye)
Yeditepe Üniversitesi Koşuyolu Hastanesi
Istanbul, 34718, Turkey (Türkiye)
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, 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
Derriford Hospital
Plymouth, Pl6 8DH, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1DD, 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 15, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2033
Last Updated
April 29, 2026
Record last verified: 2026-04
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.