Carcinoma, Non-Small-Cell LungPhase 3SUNRAY-02NCT06890598
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
A Phase 3 study testing Olomorasib, Pembrolizumab and Durvalumab in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 368 sites in 29 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Olomorasib, Pembrolizumab and Durvalumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 368 sitesin 29 countries
- Study dates
- 27 Mar 2025to Feb 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of NSCLC.
- Part A
- Clinical Stage II-IIIB (N0, N1, 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 (N0, N1, 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.
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- 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
Who cannot join
- Have known, actionable 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.
Trial locations and contacts
368 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
368 sites in 29 countries
United States93 sites, 92 recruiting
- Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
706-353-2990
Frederick Flynt
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
Jennifer Carlisle
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Samuel Rosner
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Kristen Marrone
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
225-215-1185
Victor Lin
- Recruiting
Ochsner Health Ochsner Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70816
504-842-3910
Ralph Millett
- Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Samuel Kareff
- Not yet recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
781-744-8400
Andrew Piper-Vallillo
- Recruiting
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05405
Rohit Singh
- Recruiting
Aultman Hospital
Canton, Ohio, 44710
330-438-6333
Raza Khan
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
tarek sabagh
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Mariam Alexander
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
434-924-4251
Ryan Gentzler
- Recruiting
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
Wade Iams
- Recruiting
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, 08002
Sarah Gordon
- Not yet recruiting
City of Hope, Chicago
Chicago, Illinois, 60611
Bruno Debora
- Suspended
Northwestern Memorial Hospital
Chicago, Illinois, 60611
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Frank Weinberg
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
773-834-5387
Marina Garassino
- Recruiting
Fairview Hospital
Cleveland, Ohio, 44111
Lukas Delasos
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Lukas Delasos
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
614-293-3300
Timothy Burns
- Recruiting
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Elizabeth Kander
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Khalil Choucair
- Not yet recruiting
City of Hope, Duarte
Duarte, California, 91010
626-218-5823
Christine Lovly
- Recruiting
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Perrin Romine
- Recruiting
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Fadi Kayali
- Recruiting
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
patricia Rich
- Recruiting
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
817-759-7000
Ray Page
- Recruiting
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Changqing Xie
- Recruiting
Hartford Hospital (HH)
Hartford, Connecticut, 06102
Wylie Hosmer
- Recruiting
Kelsey-Seybold Clinic
Houston, Texas, 77025
Tri Vu
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
713-441-9948
Jun Zhang
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
713-792-6363
Marcelo Vailati Negrao
- Recruiting
Clearview Cancer Institute
Huntsville, Alabama, 35805
Jorge Diaz
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
317-528-5173
Michael Eaton
- Not yet recruiting
City of Hope Lennar
Irvine, California, 92618
626-218-5823
Christine Lovly
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
865-305-8780
Ardy Davarifar
- Not yet recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
603-650-6344
Alexander Fuld
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Firas Badin
- Recruiting
Baptist Health Hamburg
Lexington, Kentucky, 40509
Firas Badin
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
310-794-7333
Jay Lee
- Recruiting
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792
608-261-1500
Cheryl Czerlanis
- Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Lukas Delasos
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Bruna Pellini
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hui-Zi Chen
- Not yet recruiting
Infirmary Cancer Care
Mobile, Alabama, 36607
251-435-2273
Jan Kemnade
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
SMO Sarah Cannon Research Inst.
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa Johnson
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Wade Iams
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
504-842-3910
Ralph Millett
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
212-305-3997
Benjamin Herzberg
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
646-608-3761
Jamie Chaft
- Not yet recruiting
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265
Evan Pisick
- Recruiting
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Mukta Pant-Purohit
- Not yet recruiting
Northport VA Medical Center
Northport, New York, 11768
631-261-4400 x12581
Harold Bien
- Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, 34474
352-732-4032
Ketan Doshi
- Recruiting
Profound Research LLC
Oceanside, California, 92056
Catherine Quinn
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Cathleen Park
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
650-725-3081
Joel Neal
- Not yet recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Jun Zhang
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107
Sarah Gordon
- Recruiting
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114
Sarah Gordon
- Not yet recruiting
City of Hope, Phoenix
Phoenix, Arizona, 85338
Amit Kulkarni
- Recruiting
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Ariel Lopez-Chavez
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Rachel Sanborn
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Rachel Sanborn
- Recruiting
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
503-249-3315
Sandeep Mashru
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
971-262-9000
naga praneeth raja
- Not yet recruiting
WakeMed Raleigh Campus
Raleigh, North Carolina, 27610
Praveen Namireddy
- Recruiting
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219
804-828-7999
Renato Martins
- Recruiting
USO - Texas Oncology - San Antonio
San Antonio, Texas, 78240
Krishna Alluri
- Recruiting
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
Eric McGary
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Perrin Romine
- Recruiting
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, 08080
Sarah Gordon
- Recruiting
Avera Cancer Institute- Research
Sioux Falls, South Dakota, 57105
605-322-6900
Benjamin Solomon
- Recruiting
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216
Maury Blitman
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
479-872-8130
Eric Schaefer
- Recruiting
Springfield Clinic Main Campus
Springfield, Illinois, 62703
Preet Singh
- Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Bryan Faller
- Recruiting
Florida Cancer Specialists North
St. Petersburg, Florida, 33701-4553
Ernesto Bustinza-Linares
- Recruiting
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
727-344-6569
Neeharika Makani
- Recruiting
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, 77479
Caesar Tin-U
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
813-745-2677
Jhanelle Gray
- Recruiting
USO - US Oncology Research Network
The Woodlands, Texas, 77380
SMO Sarah Cannon Research Inst.
- Recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
520-626-3434
Linda Garland
- Recruiting
Northwest Cancer Specialists PC
Vancouver, Washington, 98684
Anthony Van Ho
- Recruiting
BASS Cancer Center
Walnut Creek, California, 94598
Jewel Johl
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Kristen Marrone
- Recruiting
Lexington Medical Center
West Columbia, South Carolina, 29169
803-794-7511
Scott Graupner
- Recruiting
Florida Cancer Specialists East
West Palm Beach, Florida, 33401
Eric Michael Harris
- Recruiting
New England Cancer Specialists
Westbrook, Maine, 04092
207-303-3300
Christian Thomas
- Recruiting
Reliant Medical Group
Worcester, Massachusetts, 01606
508-556-5400
Bradley Switzer
China39 sites, 39 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, 455000
Yaowen Zhang
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, 100021
Nan Bi
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
13611108002
Guangying Zhu
- Recruiting
Peking University People's Hospital
Beijing, 100034
Fan Yang
- Recruiting
Beijing Cancer hospital
Beijing, 100142
Shi Yan
- Recruiting
Jilin Province Tumor Hospital
Changchun, 132000
Haifeng Liu
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
Yang Gao
- Recruiting
Hunan Cancer Hospital
Changsha, 410013
8613973135460
Hui Wang
- Recruiting
Hunan Cancer Hospital
Changsha, 410013
Lin Wu
- Recruiting
The Third People's Hospital of Chengdu (CDTPH)
Chengdu, 610031
Zhumei Luo
- Recruiting
Sichuan Cancer hospital
Chengdu, 610041
Wenxiu Yao
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Qinghua Zhou
- Recruiting
The Second Affiliated Hospital Chongqing Medical University
Chongqing, 400072
13452414579
Na Li
- Recruiting
The First People's Hospital of Foshan
Foshan, 528041
Weineng Feng
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510120
Wenzhao Zhong
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Jiancong Sun
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Liu Yang
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
Yun Fan
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
jian zeng
- Recruiting
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052
Junqiang Fan
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
13904505825
Yan Yu
- Recruiting
Jinan Central Hospital
Jinan, 250013
Meili Sun
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
Linlin Wang
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, 317000
Dongqing LV
- Recruiting
Liuzhou People's Hospital
Liuzhou, 545006
Ting Zhou
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003
Zhiye Zhang
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530021
Jiangqiong Huang
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
13818200560
Hua Zhong
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
MIN FAN
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, 515000
Fangcai Wu
- Recruiting
ShenZhen People's Hospital
Shenzhen, 518020
Lin Yang
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center
Shenzhen, 518127
Jun Liang
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Chuanyong Mu
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
Zhenfa Zhang
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Qingsong Pang
- Recruiting
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030
Qian Chu
- Recruiting
Hubei Cancer Hospital
Wuhan, 430079
Guang Han
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Yu Yao
- Recruiting
Zhongshan Peoples Hospital
Zhongshan, 528403
Minying Li
Japan22 sites, 22 recruiting
- Recruiting
Juntendo University Hospital
Bunkyō City, 113-8431
81120023812
Takehito Shukuya
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677
81120023812
Kageaki Watanabe
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
81120023812
Isamu Okamoto
- Recruiting
Saitama Medical University International Medical Center
Hidaka, 350-1298
81120023812
Atsuto Mouri
- Recruiting
Himeji Medical Center
Himeji, 670-8520
81120023812
Tetsuji Kawamura
- Recruiting
Kansai Medical University Hospital
Hirakata, 573-1191
81120023812
Takayasu Kurata
- Recruiting
Kanazawa University Hospital
Kanazawa, 920-8641
81120023812
Shinji Takeuchi
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
81120023812
Keiju Aokage
- Not yet recruiting
Kobe Minimally Invasive Cancer Center
Kobe, 650-0046
81120023812
Akito Hata
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
81120023812
Ryo Ariyasu
- Recruiting
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566
81120023812
Tadaaki Yamada
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, 411-8777
81120023812
Akira Ono
- Recruiting
Aichi Cancer Center Hospital
Nagoya, 464-8681
81120023812
Yutaka Fujiwara
- Recruiting
Miyagi Cancer Center
Natori, 981-1293
81120023812
Tatsuro Fukuhara
- Recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566
81120023812
Hiroshi Tanaka
- Recruiting
Kindai University Hospital- Osakasayama Campus
Sakai, 590-0197
81120023812
Hidetoshi Hayashi
- Recruiting
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555
81120023812
Kyoichi Okishio
- Recruiting
Hokkaido University Hospital
Sapporo, 060-8648
81120023812
Jun Sakakibara
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
81120023812
Yuhei Harutani
- Recruiting
Kanagawa Cardiovascular and Respiratory Center
Yokohama, 236-0051
81120023812
Tomohisa Baba
- Recruiting
Kanagawa cancer center
Yokohama, 2418515
81120023812
Seigo Katakura
- Recruiting
Tottori University Hospital
Yonago, 683-8504
81120023812
Tomohiro Sakamoto
South Korea20 sites, 20 recruiting
- Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, 21431
01092747783
Ju Sang Kim
- Recruiting
Pusan National University Hospital
Busan, 49241
Mi-Hyun Kim
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
Ki Hyeong Lee
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
01063522096
Sun Hyo Park
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, 41404
Shin Yup Lee
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Eunpyeong-gu, 03312
82-2-2030-4340
Chang Dong Yeo
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, 06273
821041821095
Chi Young Kim
- Recruiting
National Cancer Center
Goyang-si, 10408
82319201154
Ji-Youn Han
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128
Young-Chul Kim
- Recruiting
Yeungnam Univeristy Medical Center
Nam-gu, 42415
June Hong Ahn
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Se Hyun Kim
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
82222284190
Hye Ryun Kim
- Recruiting
Konkuk University Medical Center
Seoul, 05030
01035438353
In Ae Kim
- Recruiting
Asan Medical Center
Seoul, 05505
Chang Min Choi
- Recruiting
Samsung Medical Center
Seoul, 06351
Se-Hoon Lee
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
82222586045
SookHee Hong
- Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345
Chankwon Park
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Sung Yong Lee
- Recruiting
The Catholic University Of Korea St. Vincent's Hospital
Suwon, 16247
82-31-881-8906
Byoung Yong Shim
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Seong Hoon Yoon
Taiwan19 sites, 19 recruiting
- Recruiting
Changhua Christian Hospital
Changhua County, 50006
+886-4-7238595 ext.3934
Sheng-Hao Lin
- Recruiting
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 622
Chun-Liang Lai
- Recruiting
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
Douliu, 640
You-Yi Chen
- Recruiting
Hualien Tzu Chi Medical Center
Hualien City, 970
Chih-Bin Lin
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
88673121101-5651
Jen-Yu Hung
- Recruiting
E-Da hospital
Kaohsiung City, 82445
0975106137
Yu-Feng Wei
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301
+886-7-7317123 ext. 8199
Chin-Chou Wang
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Cheng-Yu Chang
- Recruiting
New Taipei Municipal TuCheng Hospital
New Taipei City, 236
0975366098
Chiao-En Wu
- Recruiting
Chung Shan Medical University Hospital
Taichung, 402
0424739595
Gee-Chen Chang
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
886-23592525(3259)
Tsung-Ying Yang
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chien-Chung Lin
- Recruiting
Chi Mei Medical Center
Tainan, 71004
SHU FARN TEY
- Recruiting
Chi Mei Hospital - Liouying Branch
Tainan, 73657
Wen-Tsung Huang
- Recruiting
National Taiwan University Hospital
Taipei, 10002
886-2-2312-3456
Chia-Chi Lin
- Recruiting
National Taiwan University Cancer Center (NTUCC)
Taipei, 106
886-2-23123456
Chih-Hsin Yang
- Not yet recruiting
Taipei Medical University Hospital
Taipei, 110
Shih-Hsin Hsiao
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
88628712121
Hsu-Ching Huang
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Cheng-Ta Yang
Germany18 sites, 18 recruiting
- Recruiting
Vivantes Klinikum im Friedrichshain - Landsberger Allee
Berlin, 10249
49 151 53854841
Peter Thuss-Patience
- Recruiting
Evangelische Lungenklinik Berlin
Berlin, 13125
Christian Grohe
- Recruiting
DRK Kliniken Berlin Mitte
Berlin, 13359
+493030356297
Bernd Schmidt
- Recruiting
Klinikum Chemnitz
Chemnitz, 09116
4937133343550
Stefan Hammerschmidt
- Recruiting
MV-Zentrum für Onkologie und Hämatologie
Cologne, 50677
Jan-Phillip Weber
- Recruiting
HELIOS Klinikum Erfurt
Erfurt, 99089
03617812586
Eva-Maria Barkowsky
- Recruiting
Asklepios Fachkliniken München-Gauting
Gauting, 82131
004989857914001
Niels Reinmuth
- Recruiting
Franziskus-Hospital Harderberg
Georgsmarienhütte, 49124
Petra Hoffknecht
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, 22927
Martin Reck
- Recruiting
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
Miriam Moeller
- Recruiting
Asklepios Klinik Harburg
Hamburg, 21075
Claas Wesseler
- Recruiting
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126
49 6221 3968304
Helge Bischoff
- Not yet recruiting
Lungenklinik Hemer
Hemer, 58675
Karsten Schulmann
- Recruiting
Evangelisches Krankenhaus Herne - Eickel
Herne, 44651
+4920117424015
Daniel Christoph
- Recruiting
St. Elisabeth-Krankenhaus Leipzig
Leipzig, 04277
+ 49 34139597302
Sylvia Gütz
- Recruiting
Klinikum Nürnberg Nord
Nuremberg, 90419
0911398114963
Markus Horneber
- Recruiting
Robert Bosch Krankenhaus GmbH
Stuttgart, 70376
+4971181016266
Hans-Georg Kopp
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
4970712982711
Thorben Gross
Spain18 sites, 18 recruiting
- Recruiting
Hospital Infanta Cristina
Badajoz, 06006
924218040
Marta Gonzalez Cordero
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003
34932483137
Edurne Arriola Aperribay
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Alex Martinez Marti
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Laura Mezquita Perez
- Recruiting
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, 08907
932607744
Ernest Nadal Alforja
- Recruiting
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407
Jesus Corral Jaime
- Recruiting
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
34928441738
DELVYS RODRIGUEZ ABREU
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
+34915737985
Antonio Calles Blanco
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
(+34) 913368263
Pilar Garrido Lopez
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
0034913908000
Luis Paz-Ares Rodriguez
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
34951308130
María Vanesa Gutierrez Calderon
- Recruiting
Hospital Universitari Son Espases
Palma, 07120
Aitor Azkarate Martinez
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, 31009
Maite Martinez Aguillo
- Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
34914521987
Belen Rubio Viqueira
- Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, 15706
981950511
Luis Leon Mateos
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
955013068
Reyes Bernabe Caro
- Recruiting
Hospital Clinico de Valencia
Valencia, 46010
961973500
Amelia Insa Molla
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
+34976765746
Dolores Isla Casado
Brazil16 sites, 16 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400
551733216637
Dayana Mendes Ribeiro
- Recruiting
CTO - Centro de Tratamento Oncológico
Belém, 66063-495
5591999809897
Bruno Fernandes
- Recruiting
Oncocentro de Minas Gerais
Belo Horizonte, 30180-060
Flavia Duarte
- Recruiting
Hospital Tacchini
Bento Gonçalves, 95700-084
ANDRE REIRIZ
- Recruiting
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
+5519992182311
Rafael Carmo
- Recruiting
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
Fortaleza, 60430235
558532884576
Fabio Chaves
- Recruiting
Hospital de Cancer de Londrina
Londrina, 86015-520
55 41 996379769
Mariana Piovesana
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, 59075-740
55 84 40095595
Sulene Oliveira
- Recruiting
Hospital São Lucas da PUCRS
Porto Alegre, 90610-000
Ana Caroline Gelatti
- Recruiting
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905
Tatiane Montella
- Recruiting
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, 22271-110
Clarissa Serodio da Rocha Baldotto
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
5511999685217
Gilberto Castro
- Recruiting
Hospital Sírio Libanês
São Paulo, 01308-060
Guilherme Harada
- Recruiting
Hospital Santa Catarina - Paulista
São Paulo, 01310-000
Gregorio Soares
- Recruiting
Centro Paulista de Oncologia Clínica
São Paulo, 01452-000
551135056616
William Nassib William Junior
- Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000
Milena Perez Mak
France16 sites, 16 recruiting
- Not yet recruiting
Hôpital Avicenne
Bobigny, 93000
Lise Matton
- Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677
Michael Duruisseaux
- Recruiting
Chu Grenoble Alpes
La Tronche, 38700
33476766453
Denis Moro-Sibilot
- Recruiting
Centre Leon Berard
Lyon Cedex08, 69373
33426556761
Maurice Perol
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
+33491384644
PASCALE TOMASINI
- Recruiting
Centre Antoine-Lacassagne
Nice, 06189
0492031324
Victoria ferrari
- Recruiting
Groupe hospitalier Paris saint Joseph
Paris, 75014
Charles Naltet
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
00 33 1 56 09 34 74
Elizabeth Fabre
- Recruiting
Institut Curie
Paris, 75248
33624456290
nicolas girard
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, 33600
MAEVA ZYSMAN
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Clotilde Deldycke
- Recruiting
Institut Jean Godinot
Reims, 51726
Amélie Lemoine
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033
Yannick Le Guen
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, 31059
335677718
Julien Mazieres
- Recruiting
Hôpital Robert Schuman
Vantoux, 57070
Lucile ROUSSEL
- Recruiting
Gustave Roussy
Villejuif, 94800
Fabrice Barlesi
India12 sites, 12 recruiting
- Recruiting
Hemato Oncology Clinic
Ahmedabad, 380054
09824047561
Chirag Desai
- Recruiting
Rajiv Gandhi Government General Hospital
Chennai, 600003
Kannan Jayaraman
- Recruiting
Galaxy Superspeciality Hospital
Chhatrapati Sambhajinagar, 431001
Ketan Shirsath
- Recruiting
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, 400004
+91 9619607339
Sewanti Limaye
- Recruiting
Thangam Cancer Center - Namakkal
Namakkal, 637001
Bhavesh Poladia
- Recruiting
Savera Cancer & Multi Speciality Hospital
Patna, 800020
9967673497
Avinash Pandey
- Recruiting
Deenanath Mangeshkar Hospital & Research Centre
Pune, 411004
91-20-4915-2434
Chetan Deshmukh
- Recruiting
Medipoint Hospitals Pvt. Ltd.
Pune, 411007
Rahul Kulkarni
- Recruiting
Malabar Cancer Centre - Thalassery
Thalassery, 670103
91 4902399250
Nandini R
- Recruiting
Regional Cancer Centre - Thiruvananthapuram
Thiruvananthapuram, 695011
Anoop Manoharan
- Recruiting
Pacific Medical College & Hospital
Udaipur, 313001
Manoj Mahajan
- Recruiting
Tata Memorial Centre - Homi Bhabha Cancer Hospital
Varanasi, 221002
8002583913
Bipinesh Sansar
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 01250
905353067506
Ozgur Ozyilkan
- Recruiting
Adana City Hospital
Adana, 01370
90538 609 92 02
Timucin Cil
- Recruiting
Sakarya University School of Medicine
Adapazarı, 54290
+90 5054785576
Ilhan Hacibekiroglu
- Recruiting
University of Health Sciences,Gulhane School of Medicine
Ankara, 06010
Ismail Erturk
- Recruiting
Antalya Egitim ve Arastırma Hastanesi
Antalya, 07100
905336488217
Derya KIVRAK SALIM
- Recruiting
Trakya University
Edirne, 22030
905052137335
Bulent Erdogan
- Recruiting
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310
05065118207
tulay kus
- Recruiting
İ.A.Ü VM Medical Park Florya Hastanesi
Istanbul, 34295
905322480988
Irfan Cicin
- Recruiting
Izmir Atatürk Training and Research Hospital
Izmir, 35360
905324078648
Ahmet Alacacioglu
- Recruiting
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Pendik, 34899
905323233799
Ibrahim Bayoglu
- Recruiting
Samsun Medical Park Hastanesi
Samsun, 55200
+905364247616
Dilek Erdem
Italy10 sites, 10 recruiting
- Recruiting
Instituto Tumori Giovanni Paolo II
Bari, 70124
39 080 5555442
Domenico Galetta
- Recruiting
Policlinico "G. Rodolico"
Catania, 95123
390953781496
HECTOR SOTO PARRA
- Recruiting
Ospedale San Martino
Genova, 16132
0105558918
Carlo Genova
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
390543739100
Angelo Delmonte
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
390264442291
Diego Signorelli
- Recruiting
Ospedale San Gerardo-ASST Monza
Monza, 20900
390392336040
Diego Cortinovis
- Recruiting
Azienda Ospedaliera Dei Colli
Naples, 80131
393356489706
Danilo Rocco
- Recruiting
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, 10043
390119026233
Silvia Novello
- Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, 00144
Lorenza Landi
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126
3904518123515
SARA PILOTTO
Australia8 sites, 8 recruiting
- Recruiting
Icon Cancer Centre Wesley
Auchenflower, 4066
Adam Stirling
- Recruiting
Sunshine Coast University Hospital
Birtinya, 4575
07 5202 0000
Bryan Chan
- Recruiting
Austin Health
Heidelberg, 3084
Sagun Parakh
- Recruiting
ICON Cancer Centre - Kurralta Park
Kurralta Park, 5037
882820833
Dainik Patel
- Recruiting
Tamworth Hospital
North Tamworth, 2340
Sunil Rai
- Recruiting
Sir Charles Gairdner Hospital
Perth, 6009
samantha bowyer
- Recruiting
Goulburn Valley Health
Shepparton, 3630
61358323777
Myron Klevansky
- Recruiting
Latrobe Regional Health
Traralgon, 3844
Nguyen Chau
Greece8 sites, 8 recruiting
- Recruiting
Agios Savvas Regional Cancer Hospital
Athens, 115 22
ANASTASIOS GRIVAS
- Recruiting
Errikos Dunant Hospital Center
Athens, 115 26
IOANNIS MOUNTZIOS
- Recruiting
Thoracic General Hospital of Athens "I Sotiria"
Athens, 115 27
302107700220
Konstantinos Syrigos
- Recruiting
University General Hospital of Heraklion
Heraklion, 715 00
302810392438
Sofia Agelaki
- Recruiting
University General Hospital of Larissa
Larissa, 41110
302413502785
Athanasios Kotsakis
- Recruiting
University Hospital of Patras
Pátrai, 26504
302610999791
Angelos Koutras
- Recruiting
Agios Loukas Clinic
Thessaloniki, 552 36
2310390972
Elena Fountzila
- Recruiting
European Interbalkan Medical Center
Thessaloniki, 570 01
Sofia Baka
Netherlands8 sites, 8 recruiting
- Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, 1066 CX
31205129111
Adrianus de Langen
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HV
31204444782
I Bahce
- Recruiting
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, 4818 CK
00310765953121
Kornelis van der Leest
- Recruiting
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG
0031 341 463504
L.N. Boom
- Not yet recruiting
Maastricht UMC+
Maastricht, 6229 HX
31433875051
Lizza Hendriks
- Recruiting
ETZ Elisabeth
Tilburg, 5022 GC
31132213101
Mart Schiefer
- Recruiting
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ
31883201410
Lisanne Kastelijn
- Recruiting
Isala, locatie Zwolle
Zwolle, 8025 AB
31886243254
Peter Plomp
United Kingdom7 sites, 7 recruiting
- Recruiting
Heartlands Hospital
Birmingham, B9 5SS
Shobhit Baijal
- Recruiting
University Hospitals Sussex NHS Foundation Trust
East Sussex, BN2 5BE
01273-696955 ext 64601
Kam Zaki
- Recruiting
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA
Emma Rathbone
- Recruiting
Royal Marsden Hospital (Sutton)
London, SM2 5PT
Sanjaykumar Popat
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
Sanjaykumar Popat
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Colin Lindsay
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
Louise Medley
Norway5 sites, 5 recruiting
- Recruiting
Sorlandet Sykehus Arendal
Arendal, 4838
Karina Vintermyr
- Recruiting
Haukeland Universitetssjukehus
Bergen, 5021
4755973245
Oystein Flotten
- Recruiting
Drammen Sykehus, Vestre Viken HF
Drammen, 3004
Inger Johanne Eide
- Recruiting
Sykehuset Innlandet HF Gjøvik
Gjøvik, 2819
4791395554
Daniel Heinrich
- Recruiting
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0379
47 02770
Vilde Haakensen
Belgium4 sites, 4 recruiting
- Recruiting
CHIREC - site delta
Auderghem, 1160
0032 2 434 81 13
Christophe Compère
- Recruiting
Antwerp University Hospital
Edegem, 2650
32 3 821 37 25
Jo Raskin
- Recruiting
UZ Leuven
Leuven, 3000
32 16 34 68 02
christophe Dooms
- Recruiting
AZ Delta vzw
Roeselare, 8800
003251237207
Ingel Demedts
Chile4 sites, 4 recruiting
- Recruiting
K2 Oncology
Providencia, 7510254
56 9 61157903
pablo Rodriguez Monarca
- Not yet recruiting
FALP
Santiago, 7500921
Rodrigo Uribe
- Recruiting
Centro de Oncología de Precisión
Santiago, 7560908
Pamela Salman
- Not yet recruiting
Bradfordhill
Santiago, 8420383
Carlos Rojas
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
97247776700
Alona Zer Kuch
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
97226555361
Nir Peled
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
972-9-7472414
Maya Gottfried
- Recruiting
Sheba Medical Center
Ramat Gan, 5265601
97235307096
Jair Bar
Portugal4 sites, 4 recruiting
- Recruiting
Centro Hospitalar E Universitário De Coimbra
Coimbra, 3040
Ana Figueiredo
- Recruiting
Hospital da Luz Lisboa
Lisbon, 1500-650
Joao Moreira Pinto
- Recruiting
Hospital CUF Porto
Porto, 4100-180
220039029
Venceslau Hespanhol
- Recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
Marta Soares
Romania4 sites, 4 recruiting
- Recruiting
Lotus-Med
Bucharest, 012292
Ioana Luca
- Recruiting
SC Memorial Healthcare International SRL
Bucharest, 013812
40721298677
Ingrid Iordan
- Recruiting
Institutul Oncologic
Cluj-Napoca, 400015
Tudor Ciuleanu
- Recruiting
Ovidius Clinical Hospital OCH
Ovidiu, 905900
0724877013
Laura Mazilu
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universität Graz
Graz, 8036
+43 316 38513028
Gudrun Absenger
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Michael Schumacher
- Recruiting
Klinik Floridsdorf
Vienna, 1210
43 1 27700 2212
Maximilian Hochmair
Hungary3 sites, 3 recruiting
- Recruiting
Országos Onkológiai Intézet
Budapest, 1122
Tunde Nagy
- Recruiting
Budapesti Uzsoki Utcai Kórház
Budapest, 1145
+3614673852
Csaba Mathe
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582
Zsolt Kiraly
Poland3 sites, 3 recruiting
- Recruiting
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Kielce, 25-734
48 41 3674809
Kinga Szydziak-Zwierzynska
- Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
Poznan, 60-569
616654242
Katarzyna Stencel
- Recruiting
One Day Med
Szczecin, 70-419
48914427209
Piotr Serwatowski
Slovakia3 sites, 3 recruiting
- Recruiting
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, 97517
00421915831411
Michal Urda
- Recruiting
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
Bratislava, 821 01
00421903752376
Zuzana Svihelova Liskova
- Recruiting
Vychodoslovensky Onkologicky ustav a.s.
Košice, 041 91
421556135429
Jana Jankurova
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Baden
Baden, 5404
Sacha Rothschild
- Recruiting
HFR Fribourg - Hôpital Cantonal
Fribourg, 1708
+41263062010
Alessandra Curioni-Fontecedro
- Recruiting
Kouros Moccia Oncologia
Locarno, 6600
Michail Kouros
Czechia2 sites, 2 recruiting
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, 703 00
Jaromir Roubec
- Recruiting
Fakultni nemocnice Bulovka
Prague, 180 81
420607533688
Jana Krejci
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Kerstin Gunnarsson
About this study
Official title: 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
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Olomorasib, Pembrolizumab, Durvalumab, Placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlomorasibDrug
Also called LY3537982
Administered orally.
PembrolizumabDrug
Administered intravenously (IV).
DurvalumabDrug
Administered IV.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Olomorasib + Pembrolizumab | Experimental | Participants 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. Receives: Drug: Olomorasib; Drug: Pembrolizumab |
| Part A: Placebo + Pembrolizumab | Placebo comparator | Participants 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. Receives: Drug: Pembrolizumab; Drug: Placebo |
| Part B: Olomorasib + Durvalumab | Experimental | Participants 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. Receives: Drug: Olomorasib; Drug: Durvalumab |
| Part B: Placebo + Durvalumab | Placebo comparator | Participants 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. Receives: Drug: Durvalumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Disease-Free Survival (DFS) by Investigator Assessment
DFS by Investigator Assessment
Measured: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
Part B: Progression-Free Survival (PFS) by BICR
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Measured: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary outcomes (11)
Part A & B: Overall Survival (OS)
OS
Measured: 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)
Change from baseline in HRQoL, measured by the EORTC QLQ-C30
Measured: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: PFS by Investigator
PFS per RECIST v1.1 by Investigator
Measured: 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
ORR per RECIST 1.1 by BICR and Investigator
Measured: 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
DOR per RECIST 1.1 by BICR and Investigator
Measured: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator
DCR per RECIST 1.1 by BICR and Investigator
Measured: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator
TTR per RECIST 1.1 by BICR and Investigator
Measured: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment
PFS2 by investigator assessment
Measured: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)
Changes in NSCLC-related symptoms, measured by the NSCLC-SAQ
Measured: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Measured: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Measured: Randomization through end of treatment (Estimated as approximately 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start27 Mar 2025
- Primary completionMay 2029 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890598
- Sponsor's protocol ID
- 18763
- Other IDs
- 2024-512302-25-00, J3M-MC-JZQH
- Acronym
- SUNRAY-02
- Status last verified
- Nov 2026
- First submitted
- 18 Mar 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chaft J, Lee JM, Senan S, Neal JW, Nadal E, Negrao MV, Popat S, Garassino MC, Gray JE, Lee SH, Mazieres J, Thomas M, Benes M, Liu H, Liu J, Ma QL, Segall G, Puri T, Wu YL. SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy. Future Oncol. 2026 Oct 1:1-10. doi: 10.1080/14796694.2026.2736401. Online ahead of print.
PubMed 42823821
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06890598
- Acronym / sponsor ID
- SUNRAY-02 / 18763
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Olomorasib + Pembrolizumab | Experimental | Drug: Olomorasib, Drug: PembrolizumabParticipants 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 comparator | Drug: Pembrolizumab, Drug: PlaceboParticipants 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 | Experimental | Drug: Olomorasib, Drug: DurvalumabParticipants 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 comparator | Drug: Durvalumab, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological or cytological confirmation of NSCLC.
- 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.
Key exclusion criteria (4 listed)
- Have known, actionable 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlomorasibAlso: LY3537982Administered orally. | Drug | Part A: Olomorasib + Pembrolizumab, Part B: Olomorasib + Durvalumab |
| PembrolizumabAdministered intravenously (IV). | Drug | Part A: Olomorasib + Pembrolizumab, Part A: Placebo + Pembrolizumab |
| DurvalumabAdministered IV. | Drug | Part B: Olomorasib + Durvalumab, Part B: Placebo + Durvalumab |
| PlaceboAdministered orally. | Drug | Part A: Placebo + Pembrolizumab, Part B: Placebo + Durvalumab |
Primary outcome
Part A: Disease-Free Survival (DFS) by Investigator Assessment
Time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
DFS by Investigator Assessment
Part B: Progression-Free Survival (PFS) by BICR
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
11 secondary outcomes
Part A & B: Overall Survival (OS)
Time frame: 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)
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: PFS by Investigator
Time frame: 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
Time frame: 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
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment
Time frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 42823821Chaft J, Lee JM, Senan S, Neal JW, Nadal E, Negrao MV, Popat S, Garassino MC, Gray JE, Lee SH, Mazieres J, Thomas M, Benes M, Liu H, Liu J, Ma QL, Segall G, Puri T, Wu YL. SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy. Future Oncol. 2026 Oct 1:1-10. doi: 10.1080/14796694.2026.2736401. Online ahead of print.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
368 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olomorasib, Pembrolizumab and Durvalumab in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 368 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 368 sites in United States, China, Japan, South Korea, Taiwan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Disease-Free Survival (DFS) by Investigator Assessment (time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.