A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
SUNRAY-01
SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
4 other identifiers
interventional
1,264
28 countries
419
Brief Summary
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
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 2023
Longer than P75 for phase_3
419 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
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Start
First participant enrolled
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
April 20, 2026
April 1, 2026
3.9 years
November 1, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and 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 first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Secondary Outcomes (15)
Part A and Part B: Overall Survival (OS)
Randomization to date of death from any cause. (Estimated as up to 3 years)
Part A and Part B: PFS
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Randomization to disease progression or death. (Estimated as approximately 1 year)
Part A and Part B: Duration of Response (DOR)
Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year)
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)
- +10 more secondary outcomes
Study Arms (8)
Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab
EXPERIMENTALLY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab
EXPERIMENTALLY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum
EXPERIMENTALLY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part A: LY3537982 plus Pembrolizumab
EXPERIMENTALLY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part A: Placebo plus Pembrolizumab
PLACEBO COMPARATORPlacebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
EXPERIMENTALLY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
PLACEBO COMPARATORPlacebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part C: LY3537982 plus Pembrolizumab
EXPERIMENTALLY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Interventions
Administered orally.
Administered IV.
Administered orally.
Administered IV.
Administered IV.
Administered IV.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
- Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
- Must have disease with evidence of KRAS G12C mutation.
- Must have known programmed death-ligand 1 (PD-L1) expression
- Part A: Greater than or equal to (≥)50 percent (%).
- Part B: 0% to 100%.
- Part C: \<50%.
- Must have measurable disease per RECIST v1.1.
- Must have an ECOG performance status of 0 or 1.
- Estimated life expectancy ≥12 weeks.
- Ability to swallow capsules.
- 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.
- +1 more criteria
You may not qualify if:
- Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
- Have had any of the following prior to randomization:
- \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
- \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
- Have known active central nervous system metastases and/or carcinomatous meningitis.
- Have predominantly squamous cell histology for NSCLC
- Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (422)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mercy Cancer Center
Merced, California, 95340, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
BASS Cancer Center
Walnut Creek, California, 94598, United States
USO - Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Millennium Oncology Research Clinic
Hollywood, Florida, 33024, 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
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Springfield Clinic Main Campus
Springfield, Illinois, 62702, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Health
Indianapolis, Indiana, 46237, United States
Community Cancer Center North
Indianapolis, Indiana, 46250, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205, United States
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
USO - Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101, United States
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801, United States
Oncology Hematology Associates
Springfield, Missouri, 65807, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Valley Hospital, Inc.
Paramus, New Jersey, 07652, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Maimonides Cancer Center
Brooklyn, New York, 11220, 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
Manhattan Eye, Ear and Throat Hospital
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
UNC REX Cancer Center
Raleigh, North Carolina, 27607, United States
USO - Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210, United States
USO - Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504, 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
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Lifespan Cancer Institute
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, 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
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
USO - US Oncology Research Network
Nashville, Tennessee, 37203, United States
USO - Texas Oncology
Austin, Texas, 78745, United States
William Beaumont Army Medical Center
Fort Bliss, Texas, 79918, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, 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
Webster, Texas, 77598, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
USO - Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
USO - Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical
Madison, Wisconsin, 53715, United States
Royal Adelaide Hospital
Adelaide, 5000, Australia
Icon Cancer Centre Wesley
Auchenflower, 4066, Australia
Ballarat Health Services
Ballarat Central, 3350, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Gosford Hospital
Gosford, 2250, Australia
Mackay Base Hospital
Mackay, 4740, Australia
St Vincent's Hospital
Melbourne, 3065, Australia
Sir Charles Gairdner Hospital
Perth, 6009, Australia
Goulburn Valley Health
Shepparton, 3630, Australia
Gold Coast University Hospital
Southport, 4215, Australia
The Townsville Hospital
Townsville, 4814, Australia
Landeskrankenhaus Feldkirch
Feldkirch, 6800, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Klinik Floridsdorf
Vienna, 1210, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
CHIREC - site delta
Auderghem, 1160, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
AZ Glorieux Ronse
Ronse, 9600, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir, 5530, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400, Brazil
Hospital Tacchini
Bento Gonçalves, 95700-084, Brazil
Hospital São Domingos
Bequimão, 65060-645, Brazil
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
Brasília, 70200-730, Brazil
Hospital Universitário Evangélico Mackenzie
Curitiba, 80730-150, Brazil
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430235, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, 98700-000, Brazil
Hospital Brasilia
Lago Sul, 71.635-610, Brazil
Hospital de Cancer de Londrina
Londrina, 86015-520, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, 59062-000, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Oncominas
Pouso Alegre, 37554-216, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro, 20231-050, 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
Faculdade de Medicina do ABC
Santo André, 09060-650, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090000, Brazil
COE Ensino e Pesquisa
São José dos Campos, 12242-660, 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
Hospital BP
São Paulo, 01321-001, Brazil
Hospital Paulistano
São Paulo, 01321-001, Brazil
Centro Paulista de Oncologia Clínica
São Paulo, 01452-000, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, 04014-002, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
São Paulo, 04039-901, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000, Brazil
CEDOES
Vitória, 29055450, Brazil
BC Cancer Abbotsford
Abbotsford British Columbia, V2S 0C2, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6, Canada
BC Cancer Vancouver
Vancouver, V5Z 4E6, Canada
Cancer Hospital Chinese Academy of Medical Science
Beijing, 100021, China
Beijing Cancer hospital
Beijing, 100142, China
Jilin Province Tumor Hospital
Changchun, 130000, China
Hunan Cancer Hospital
Changsha, 410013, China
Hunan Cancer Hospital
Changsha, 410013, China
The First People's Hospital of Changzhou
Changzhou, 213003, 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
Fujian Cancer Hospital
Fuzhou, 350014, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510170, China
Hainan General Hospital
Haikou, 570311, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Sir Run Run Shaw Hospital
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, 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, 317099, China
LinYi Cancer Hospital
Linyi, 276001, China
Liuzhou People's Hospital
Liuchow, 545006, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Nanjing First Hospital
Nanjing, 210012, China
Shanghai Chest Hospital
Shanghai, 200030, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, 830000, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030, China
Wuhan Union Hospital
Wuhan, 430048, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Wannan Medical College Yijishan Hospital
Wuhu, 241001, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
Xiangyang Central Hospital
Xiangyang, 441021, China
Yichang Central People's Hospital
Yichang, 443003, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, 524001, China
ZhuZhou Central Hospital
Zhuzhou, 412007, China
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, 703 84, Czechia
Fakultni nemocnice Bulovka
Prague, 180 81, Czechia
Roskilde University Hospital
Roskilde, 4000, Denmark
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918, France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677, France
CHU Lille - Institut Coeur Poumon
Lille, 59037, France
Centre Leon Berard
Lyon Cedex08, 69373, France
Centre Antoine-Lacassagne
Nice, 06189, 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
Nouvel Hôpital Civil (NHC)
Strasbourg, 67091, France
Hôpital Foch
Suresnes, 92151, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, 83100, France
CHU de Toulouse - Hopital Larrey
Toulouse, 31059, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Hôpital Robert Schuman
Vantoux, 57070, France
Gustave Roussy
Villejuif, 94800, France
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf
Berlin, 14165, Germany
Klinikum Chemnitz
Chemnitz, 09116, Germany
MV-Zentrum für Onkologie und Hämatologie
Cologne, 50677, Germany
Onkologiezentrum Donauwörth
Donauwörth, 86609, Germany
HELIOS Klinikum Erfurt
Erfurt, 99089, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, 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
Hämato-Onkologie Hamburg, Prof. Laack und Partner
Hamburg, 20251, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, 48149, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Agios Savvas Regional Cancer Hospital
Athens, 115 22, Greece
Errikos Dunant Hospital Center
Athens, 115 26, Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, 11527, Greece
Attikon General University Hospital
Chaïdári, 12462, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
University Hospital of Patras
Pátrai, 26504, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, 540 07, Greece
European Interbalkan Medical Center
Thessaloniki, 570 01, Greece
G. Papanikolaou General Hospital
Thessaloniki, 570 10, Greece
Országos Korányi Pulmonológiai Intézet
Budapest, 1121, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
Budapesti Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000, Hungary
Hemato Oncology Clinic
Ahmedabad, 380054, India
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, 590010, India
SRV Hospitals
Bengaluru, 560027, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Ashwin Hospital
Coimbatore, 641012, India
Nizam's Institute of Medical Sciences
Hyderabad, 500082, India
Krishna Institute of Medical Sciences - Karad
Karad, 415539, India
Kolhapur Cancer Centre Private Limited
Kolhāpur, 416234, India
HCG Manavata Cancer Centre
Nashik, 422001, India
Advanced Centre for Treatment Research and Education in Cancer
Navi Mumbai, 410210, India
Jawaharlal Institute Of Postgraduate Medical Education And Research
Puducherry, 605006, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, 411001, India
Sahyadri Super Speciality Hospital
Pune, 411004, India
Lifepoint Multispeciality Hospital
Pune, 411057, 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
Mahatma Gandhi Cancer Hospital and Research Institute
Visakhapatnam, 530017, India
Instituto Tumori Giovanni Paolo II
Bari, 70124, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Policlinico "G. Rodolico"
Catania, 95123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, 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
Istituto Nazionale Tumori Regina Elena
Rome, 00144, Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
National Hospital Organization Asahikawa Medical Center
Asahikawa, 0708644, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, 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
Ibaraki Prefectural Central Hospital
Kasama, 309-1793, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Japanese Foundation for Cancer Research
Kōtō City, 135-8550, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, 411-8777, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681, Japan
Miyagi Cancer Center
Natori, 981-1293, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kindai University Hospital- Osakasayama Campus
Sakai, 590-0197, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai, 591-8555, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Ube, 755-0241, Japan
Tochigi Cancer Center
Utsunomiya, 320-0834, 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
CIO - Centro de Inmuno-Oncología de Occidente
Guadalajara, 44630, Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44670, Mexico
Actualidad Basada en la Investigación del Cáncer
Guadalajara, 44680, Mexico
Renati Innovation
Guadalajara, 44680, Mexico
Health Pharma Querétaro
Juriquilla, 76230, Mexico
Preparaciones Oncológicas S.C.
León, 37178, Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, 03100, Mexico
Higiea Oncologia
Mexico City, 11819, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 64460, Mexico
Avix Investigación Clinica, S.C.
Monterrey, 64623, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, 68020, Mexico
Clinica Integral Internacional de Oncología
Puebla City, 72530, Mexico
Oncare - Unidad Valle
San Pedro Garza García, 66220, Mexico
Arké SMO S.A de C.V
Veracruz, 91900, Mexico
Jeroen Bosch Hospital
's-Hertogenbosch, 5223 GZ, Netherlands
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG, Netherlands
Tergooiziekenhuizen, locatie Hilversum
Hilversum, 1213 XZ, Netherlands
Frisius Medisch Centrum
Leeuwarden, 8934 AD, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ, Netherlands
Haukeland Universitetssjukehus
Bergen, 5021, Norway
Drammen Sykehus, Vestre Viken HF
Drammen, 3004, Norway
Sykehuset Innlandet HF Gjøvik
Gjøvik, 2819, Norway
Akershus Universitetssykehus
Lørenskog, 1478, Norway
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379, Norway
Stavanger Universitetssykehus
Stavanger, 4021, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce, 25-734, Poland
One Day Med
Szczecin, 70-419, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Centro Hospitalar E Universitário De Coimbra
Coimbra, 3004-561, Portugal
Champalimaud Foundation
Lisbon, 1400-038, Portugal
Hospital da Luz Lisboa
Lisbon, 1500-650, Portugal
Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001, 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
Gral Medical Diagnostic Center
Bucharest, 031422, Romania
Institutul Oncologic
Cluj-Napoca, 400015, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, 200542, Romania
Ovidius Clinical Hospital OCH
Ovidiu, 905900, Romania
S C Oncocenter Oncologie Clinica S R L
Timișoara, 300166, Romania
Cabinet Medical Oncomed
Timișoara, 300239, Romania
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, 58128, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, 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
CHUAC-Hospital Teresa Herrera
A Coruña, 15006, Spain
Hospital Infanta Cristina
Badajoz, 06006, Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, 48903, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, 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
Complejo Asistencial Universitario de León - Hospital de León
León, 24071, 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
Mälarsjukhuset
Eskilstuna, 631 88, Sweden
Västmanlands Sjukhus Västerås
Västerås, 721 89, Sweden
CHUV (centre hospitalier universitaire vaudois)
Lausanne, 1011, Switzerland
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, 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
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, 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
National Taiwan University Hospital - Hsinchu branch
Zhubei, 302, Taiwan
Adana Medical Park Seyhan Hastanesi
Adana, 01140, Turkey (Türkiye)
Adana City Hospital
Adana, 01370, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07059, Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, 07090, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21200, Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, 34093, Turkey (Türkiye)
İ.A.Ü VM Medical Park Florya Hastanesi
Istanbul, 34295, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi
Izmir, 35360, Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, 41380, Turkey (Türkiye)
Ondokuz Mayıs Universitesi
Samsun, 55270, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Ninewells Hospital and Medical School
Dundee, DD1 9SY, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Mount Vernon Hospital
Northwood, HA6 2RN, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Peters S, Hochmair M, Arbour KC, Rodriguez LP, Reck M, Leal T, R Lindsay C, Shun L, William WN, Spira AI, Sabari JK, Henning Gronberg B, Nishio M, Burns TF, Girard N, Capuzzo F, Merced A, Fasnacht N, Visseren-Grul C, Negrao MV. SUNRAY-01 trial protocol: an innovative study design of olomorasib and pembrolizumab with or without chemotherapy in KRAS G12C NSCLC. Future Oncol. 2026 Apr 6:1-10. doi: 10.1080/14796694.2026.2651961. Online ahead of print.
PMID: 41940628DERIVED
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
- Masking Details
- Parts A and B are double blind. Dose Optimization, Safety Lead-In for Part B and Part C are open label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2023
First Posted
November 7, 2023
Study Start
December 21, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
January 1, 2031
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.