Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
SUNRAY-02
A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
3 other identifiers
interventional
700
28 countries
352
Brief Summary
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Longer than P75 for phase_3
352 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 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2032
April 20, 2026
April 1, 2026
4.1 years
March 18, 2025
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Part A: Disease-Free Survival (DFS) by Investigator Assessment
DFS by Investigator Assessment
Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).
Part B: Progression-Free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary Outcomes (11)
Part A & B: Overall Survival (OS)
Randomization to disease progression or death from any cause (Estimated as approximately 5 years).
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)
Randomization through end of treatment (Estimated as approximately 3 years).
Part B: PFS
Randomization to disease progression or death from any cause (Estimated as approximately 3 years)
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR and Investigator
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
- +6 more secondary outcomes
Study Arms (4)
Part A: Olomorasib + Pembrolizumab
EXPERIMENTALParticipants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Part A: Placebo + Pembrolizumab
PLACEBO COMPARATORParticipants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Part B: Olomorasib + Durvalumab
EXPERIMENTALParticipants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Part B: Placebo + Durvalumab
PLACEBO COMPARATORParticipants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Interventions
Administered orally.
Administered intravenously (IV).
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of NSCLC.
- Part A
- Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
- Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
- Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
- Must have disease with evidence of KRAS G12C mutation.
- Must have known programmed death-ligand 1 (PD-L1) expression
- Must have an ECOG performance status of 0 or 1.
- Able to swallow oral medication.
- Must have adequate laboratory parameters.
- Contraceptive use should be consistent with local regulations for those participating in clinical studies.
- Women of childbearing potential must
- Have a negative pregnancy test.
- Not be breastfeeding during treatment
You may not qualify if:
- Have known changes in the EGFR or ALK genes.
- Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
- Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
- Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- AstraZenecacollaborator
Study Sites (355)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Infirmary Cancer Care
Mobile, Alabama, 36607, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404, 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
Stanford Cancer Center
Palo Alto, California, 94304, United States
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108, United States
BASS Cancer Center
Walnut Creek, California, 94598, United States
Hartford Hospital (HH)
Hartford, Connecticut, 06102, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
University of Florida - Jacksonville
Jacksonville, Florida, 32209, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, 34474, United States
Florida Cancer Specialists North
St. Petersburg, Florida, 33701-4553, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064, United States
Springfield Clinic Main Campus
Springfield, Illinois, 62703, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Franciscan Health
Indianapolis, Indiana, 46237, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Baptist Health Hamburg
Lexington, Kentucky, 40509, United States
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Ochsner Health Ochsner Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70816, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
New England Cancer Specialists
Westbrook, Maine, 04092, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Reliant Medical Group
Worcester, Massachusetts, 01606, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, 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
Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Northport VA Medical Center
Northport, New York, 11768, United States
Aultman Hospital
Canton, Ohio, 44710, 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
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107, United States
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
USO - Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, 77479, United States
USO - US Oncology Research Network
The Woodlands, Texas, 77380, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05405, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216, United States
Northwest Cancer Specialists PC
Vancouver, Washington, 98684, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Icon Cancer Centre Wesley
Auchenflower, 4066, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Austin Health
Heidelberg, 3084, Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, 5037, Australia
Tamworth Hospital
North Tamworth, 2340, Australia
Sir Charles Gairdner Hospital
Perth, 6009, Australia
Goulburn Valley Health
Shepparton, 3630, Australia
Latrobe Regional Health
Traralgon, 3844, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Klinik Floridsdorf
Vienna, 1210, Austria
CHIREC - site delta
Auderghem, 1160, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
AZ Delta vzw
Roeselare, 8800, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400, Brazil
CTO - Centro de Tratamento Oncológico
Belém, 66063-495, Brazil
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060, Brazil
Hospital Tacchini
Bento Gonçalves, 95700-084, Brazil
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430235, Brazil
Hospital de Cancer de Londrina
Londrina, 86015-520, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, 59075-740, 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 D'Or Pesquisa e Ensino
Rio de Janeiro, 22271-110, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
Hospital Sírio Libanês
São Paulo, 01308-060, Brazil
Hospital Santa Catarina - Paulista
São Paulo, 01310-000, Brazil
Centro Paulista de Oncologia Clínica
São Paulo, 01452-000, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000, Brazil
K2 Oncology
Providencia, 7510254, Chile
FALP
Santiago, 7500921, Chile
Centro de Oncología de Precisión
Santiago, 7560908, Chile
Bradfordhill
Santiago, 8420383, Chile
Anyang Cancer Hospital
Anyang, 455000, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, 100021, China
China-Japan Friendship Hospital
Beijing, 100029, China
Peking University People's Hospital
Beijing, 100034, China
Beijing Cancer hospital
Beijing, 100142, China
Jilin Cancer Hospital
Changchun, 132000, China
Xiangya Hospital Central South University
Changsha, 410008, China
Xiangya Hospital Central South University
Changsha, 410008, China
Hunan Cancer Hospital
Changsha, 410013, China
Hunan Cancer Hospital
Changsha, 410013, China
The Third People's Hospital of Chengdu (CDTPH)
Chengdu, 610031, China
Sichuan Cancer hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The Second Affiliated Hospital Chongqing Medical University
Chongqing, 400072, China
The First People's Hospital of Foshan
Foshan, 528041, China
Guangdong Provincial People's Hospital
Guangzhou, 510120, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jinan Central Hospital
Jinan, 250013, China
Shandong Cancer Hospital
Jinan, 250117, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
Liuzhou People's Hospital
Liuchow, 545006, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021, China
The Second People's Hospital of Neijiang
Neijiang, 641000, China
Shanghai Chest Hospital
Shanghai, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Cancer Hospital of Shantou University Medical College
Shantou, 515000, China
ShenZhen People's Hospital
Shenzhen, 518020, China
Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center
Shenzhen, 518127, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030, China
Hubei Cancer Hospital
Wuhan, 430079, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
Zhongshan Peoples Hospital
Zhongshan, 528403, China
ZhuZhou Central Hospital
Zhuzhou, 412007, China
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, 703 00, Czechia
Fakultni nemocnice Bulovka
Prague, 180 81, Czechia
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677, France
Chu Grenoble Alpes
La Tronche, 38700, France
Centre Leon Berard
Lyon Cedex08, 69373, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915, France
Centre Antoine-Lacassagne
Nice, 06189, France
Groupe hospitalier Paris saint Joseph
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Institut Curie
Paris, 75248, France
CHU Bordeaux Haut-Leveque
Pessac, 33600, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Institut Jean Godinot
Reims, 51726, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
CHU de Toulouse - Hopital Larrey
Toulouse, 31059, France
Hôpital Robert Schuman
Vantoux, 57070, France
Gustave Roussy
Villejuif, 94800, France
Vivantes Klinikum im Friedrichshain - Landsberger Allee
Berlin, 10249, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
DRK Kliniken Berlin Mitte
Berlin, 13359, Germany
Klinikum Chemnitz
Chemnitz, 09116, Germany
MV-Zentrum für Onkologie und Hämatologie
Cologne, 50677, Germany
Klinikum Köln-Merheim
Cologne, 51109, Germany
Onkologiezentrum Donauwörth
Donauwörth, 86609, Germany
HELIOS Klinikum Erfurt
Erfurt, 99089, Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
Franziskus-Hospital Harderberg
Georgsmarienhütte, 49124, Germany
LungenClinic Grosshansdorf
Großhansdorf, 22927, Germany
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126, Germany
Evangelisches Krankenhaus Herne - Eickel
Herne, 44651, Germany
St. Elisabeth-Krankenhaus Leipzig
Leipzig, 04277, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, 70376, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Agios Savvas Regional Cancer Hospital
Athens, 115 22, Greece
Errikos Dunant Hospital Center
Athens, 115 26, Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, 115 27, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26504, Greece
Agios Loukas Clinic
Thessaloniki, 552 36, Greece
European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Budapesti Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Hemato Oncology Clinic
Ahmedabad, 380054, India
Galaxy Superspeciality Hospital
Aurangabad, 431001, India
Rajiv Gandhi Government General Hospital
Chennai, 600003, India
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, 400004, India
Thangam Cancer Center - Namakkal
Namakkal, 637001, India
Savera Cancer & Multi Speciality Hospital
Patna, 800020, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, 411004, India
Medipoint Hospitals Pvt. Ltd.
Pune, 411007, India
Malabar Cancer Centre - Thalassery
Thalassery, 670103, India
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, 695011, India
Pacific Medical College & Hospital
Udaipur, 313001, India
Tata Memorial Centre - Homi Bhabha Cancer Hospital
Varanasi, 221002, India
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9013102, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Instituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Policlinico "G. Rodolico"
Catania, 95123, Italy
Ospedale San Martino
Genova, 16132, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Ospedale San Gerardo-ASST Monza
Monza, 20900, Italy
Azienda Ospedaliera Dei Colli
Naples, 80131, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, 10043, Italy
Istituto Nazionale Tumori Regina Elena
Rome, 00144, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
Himeji Medical Center
Himeji, 670-8520, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, 411-8777, Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681, Japan
Miyagi Cancer Center
Natori, 981-1293, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Kindai University Hospital- Osakasayama Campus
Sakai, 590-0197, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051, Japan
Kanagawa cancer center
Yokohama, 2418515, Japan
Tottori University Hospital
Yonago, 683-8504, Japan
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, 1066 CX, Netherlands
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HV, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, 4818 CK, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ, Netherlands
Isala, locatie Zwolle
Zwolle, 8025 AB, Netherlands
Sorlandet Sykehus Arendal
Arendal, 4838, Norway
Haukeland Universitetssjukehus
Bergen, 5021, Norway
Drammen Sykehus, Vestre Viken HF
Drammen, 3004, Norway
Sykehuset Innlandet HF Gjøvik
Gjøvik, 2819, Norway
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379, Norway
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce, 25-734, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, 60-569, Poland
One Day Med
Szczecin, 70-419, Poland
Centro Hospitalar E Universitário De Coimbra
Coimbra, 3040, Portugal
Hospital da Luz Lisboa
Lisbon, 1500-650, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Lotus-Med
Bucharest, 012292, Romania
SC Memorial Healthcare International SRL
Bucharest, 013812, Romania
Institutul Oncologic
Cluj-Napoca, 400015, Romania
Ovidius Clinical Hospital OCH
Ovidiu, 905900, Romania
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 97517, Slovakia
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
Bratislava, 821 01, Slovakia
Vychodoslovensky Onkologicky ustav a.s.
Košice, 041 91, Slovakia
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, 21431, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Kyungpook National University Chilgok Hospital
Deagu, 41404, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Yeungnam Univeristy Medical Center
Nam-gu, 42415, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, 16247, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Hospital Infanta Cristina
Badajoz, 06006, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, 08907, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Complejo Hospitalario de Navarra
Pamplona, 31009, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clinico de Valencia
Valencia, 46010, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Kantonsspital Baden
Baden, 5404, Switzerland
HFR Fribourg - Hôpital Cantonal
Fribourg, 1708, Switzerland
Kouros Moccia Oncologia
Locarno, 6600, Switzerland
Changhua Christian Hospital
Changhua County, 50006, Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 622, Taiwan
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
Douliu, 640, Taiwan
Hualien Tzu Chi Medical Center
Hualien City, 970, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
E-Da hospital
Kaohsiung City, 82445, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, 236, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
Chi Mei Hospital - Liouying Branch
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
National Taiwan University Cancer Center (NTUCC)
Taipei, 106, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250, Turkey (Türkiye)
Adana City Hospital
Adana, 01370, Turkey (Türkiye)
Sakarya University School of Medicine
Adapazarı, 54290, Turkey (Türkiye)
University of Health Sciences,Gulhane School of Medicine
Ankara, 06010, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
İ.A.Ü VM Medical Park Florya Hastanesi
Istanbul, 34295, Turkey (Türkiye)
Izmir Atatürk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Pendik, 34899, Turkey (Türkiye)
Samsun Medical Park Hastanesi
Samsun, 55200, Turkey (Türkiye)
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
University Hospitals Sussex NHS Foundation Trust
East Sussex, BN2 5BE, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, 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)
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
- Masking Details
- Both Part A and B are randomized, double-blind, placebo-controlled.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2025
First Posted
March 24, 2025
Study Start
March 27, 2025
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
February 1, 2032
Last Updated
April 20, 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 and 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 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.