A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C

Carcinoma, Non-Small-Cell Lung Clinical Trial

— SUNRAY-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119581
• Other study ID #: 18612
• Secondary ID: J3M-MC-JZQBU1111
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2023
• Est. completion date: October 2029

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess if adding LY3537982 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.

Description:

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1016
• Est. completion date: October 2029
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%.

• 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.

• Not be breastfeeding during treatment and after study intervention for at least 180 days.

Exclusion Criteria:

• 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.

Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

• Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.

• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

• Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis

Intervention

Drug:
• LY3537982
Administered orally.
• Pembrolizumab
Administered IV.
• Placebo
Administered orally.
• Cisplatin
Administered IV.
• Carboplatin
Administered IV.
• Pemetrexed
Administered IV.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Icon Cancer Centre Wesley	Auchenflower	Queensland
Australia	Ballarat Health Services	Ballarat Central	Victoria
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Mackay Base Hospital	Mackay	Queensland
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Goulburn Valley Health	Shepparton	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	The Townsville Hospital	Townsville	Queensland
Austria	Landeskrankenhaus Feldkirch	Feldkirch	Vorarlberg
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz	Oberösterreich
Austria	Klinik Floridsdorf	Wien
Belgium	ZNA Middelheim	Antwerp	Antwerpen
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge	West-Vlaanderen
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	AZ Sint-Maarten, Campus Leopoldstraat 2	Mechelen	Antwerpen
Belgium	Clinique Saint Pierre	Ottignies	Brabant Wallon
Belgium	AZ Glorieux Ronse	Ronse
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne	Yvoir	Namur
Brazil	Hospital Tacchini	Bento Gonçalves	Rio Grande Do Sul
Brazil	Hospital São Domingos	Bequimao	Maranhão
Brazil	Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul	Brasilia	Distrito Federal
Brazil	Hospital Universitário Evangélico Mackenzie	Curitiba	Parana
Brazil	Centro de Pesquisa Clínica do Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	Rio Grande Do Sul
Brazil	Hospital Brasilia	Lago sul	Distrito Federal
Brazil	Hospital de Cancer de Londrina	Londrina	Paraná
Brazil	Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande Do Norte
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Oncominas	Pouso Alegre	Minas Gerais
Brazil	Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA	Rio de Janeiro
Brazil	Instituto Nacional de Câncer - INCA	Rio de Janeiro
Brazil	Clinica Amo - Rio Vermelho	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	COE Ensino e Pesquisa	São José dos Campos	São Paulo
Brazil	Hospital BP	Sao Paulo	São Paulo
Brazil	Hospital Paulistano	Sao Paulo	São Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR)	Sao Paulo	São Paulo
Brazil	Centro Paulista de Oncologia Clínica	São Paulo
Brazil	Hospital Sírio Libanês	São Paulo
Brazil	Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T	São Paulo
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo
Canada	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Unité de Recherche Clinique du CISSS des Laurentides	Saint-Jérôme	Quebec
Canada	BC Cancer Vancouver	Vancouver	British Columbia
China	Beijing Cancer hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Sichuan Cancer hospital	Chengdu
China	The Third People's Hospital of Chengdu (CDTPH)	Chengdu	Sichuan
China	West China Hospital, Sichuan University	ChengDu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang
China	LinYi Cancer Hospital	Linyi	Shandong
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Hwa Mei Hospital University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of the Third Military Medical University	Shapingba	Chongqing
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumchi	Xinjiang
China	Xinjiang Medical University Cancer Hospital - Urumqi	Urumqi	Xinjiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Yichang Central People's Hospital	Yichang
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	ZhuZhou Central Hospital	Zhuzhou	Hunan
Czechia	Nemocnice AGEL Ostrava - Vitkovice a.s.	Ostrava	Ostrava Me
Czechia	Fakultni nemocnice Bulovka	Prague	Praha 8
Denmark	Næstved Sygehus	Næstved	Sjælland
Denmark	Roskilde University Hospital	Roskilde	Sjælland
France	Sainte Catherine Institut du Cancer Avignon Provence	Avignon	Vaucluse
France	Hospices Civils de Lyon - Hopital Louis Pradel	Bron	Rhône
France	CHU Lille - Institut Coeur Poumon	Lille Cedex	Nord
France	Centre Leon Berard	Lyon	Rhône-Alpes
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
France	Centre Antoine-Lacassagne	Nice	Alpes-Maritimes
France	Institut Curie	Paris
France	CHU Bordeaux Haut-Leveque	Pessac	Aquitaine
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Institut Jean Godinot	Reims	Marne
France	Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou	Rennes	Ille-et-Vilaine
France	Institut de Cancérologie de l'Ouest	Saint Herblain	Loire-Atlantique
France	Nouvel Hôpital Civil (NHC)	Strasbourg	Alsace
France	Hôpital Foch	Suresnes	Hauts-de-Seine
France	Centre Hospitalier intercommunal de Toulon La Seyne sur Mer	Toulon	Provence-Alpes-Côte-d'Azur
France	CHU de Toulouse - Hopital Larrey	Toulouse	Haute-Garonne
France	Hôpital Robert Schuman	Vantoux	Lorraine
France	Gustave Roussy	Villejuif	Val-de-Marne
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Helios Klinikum Emil von Behring Berlin-Zehlendorf	Berlin
Germany	Onkologiezentrum Donauwörth	Donauwörth	Bayern
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Asklepios Fachkliniken München-Gauting	Gauting	Bayern
Germany	SRH Wald-Klinikum Gera	Gera	Thüringen
Germany	LungenClinic Grosshansdorf	Grosshansdorf	Schleswig-Holstein
Germany	Krankenhaus Martha-Maria Halle-Dölau	Halle	Sachsen-Anhalt
Germany	Hämato-Onkologie Hamburg, Prof. Laack und Partner	Hamburg
Germany	Thoraxklinik-Heidelberg gGmbH	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum Münster - Albert Schweitzer Campus	Münster	Nordrhein-Westfalen
Germany	Klinikum Nürnberg Nord	Nürnberg	Bayern
Germany	Universitaetsklinikum Tuebingen	Tübingen	Baden-Württemberg
Greece	Agios Savvas Regional Cancer Hospital	Athens	Attikí
Greece	Errikos Dunant Hospital Center	Athens	Attikí
Greece	Sotiria Thoracic Diseases Hospital of Athens	Athens	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	University Hospital of Patras	Patras	Acha?a
Greece	European Interbalkan Medical Center	Thessaloniki	Thessaloníki
Greece	G. Papanikolaou General Hospital	Thessaloniki	Thessaloníki
Hungary	Országos Korányi Pulmonológiai Intézet	Budapest	Pest
Hungary	Országos Onkológiai Intézet	Budapest
Hungary	Uzsoki Utcai Kórház	Budapest
Hungary	Farkasgyepui Tudogyogyintezet	Farkasgyepu	Veszprém
Hungary	Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemét	Bács-Kiskun
India	KLES Dr. Prabhakar Kore Hospital & M.R.C	Belagave	Karnataka
India	SRV Hospitals	Bengaluru	Karnataka
India	All India Institute of Medical Sciences	Bhubaneswar	Odisha
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Ashwin Hospital	Coimbatore	Tamil Nadu
India	Nizam's Institute of Medical Sciences	Hyderabad	Telangana
India	Krishna Institute of Medical Sciences - Karad	Karad	Maharashtra
India	Kolhapur Cancer Centre Private Limited	Kolhapur	Maharashtra
India	Tata Medical Center	Kolkata	West Bengal
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
India	Rajiv Gandhi Cancer Institute And Research Centre	New Delhi	Delhi
India	Jawaharlal Institute Of Postgraduate Medical Education And Research	Puducherry
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
India	Regional Cancer Centre - Thiruvananthapuram	Thiruvananthapuram	Kerala
India	Banaras Hindu University	Varanasi	Uttar Pradesh
India	Tata Memorial Centre - Homi Bhabha Cancer Hospital	Varanasi	Uttar Pradesh
Italy	IRCCS - AOU di Bologna	Bologna
Italy	Policlinico "G. Rodolico"	Catania	Sicilia
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Lombardia
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli	Campania
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	Istituto Nazionale Tumori Regina Elena	Rome	Roma
Italy	Ospedale di Circolo e Fondazione Macchi Varese	Varese
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona	Veneto
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Tokyo Metropolitan Komagome Hospital	Bunkyo-Ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Himeji Medical Center	Himeji	Hyogo
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Tominaga Hospital	Nagaizumi-cho,Sunto-gun	Shizuoka
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Miyagi Cancer Center	Natori	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital- Osakasayama Campus	Osakasayama	Osaka
Japan	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization Yamaguchi Ube Medical Center	Ube	Yamaguchi
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do [Chungbuk]
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Gangnam Severance Hospital	Gangnam-gu	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	National Cancer Center	Goyang-si	Kyonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonranamdo
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Hanyang University Seoul Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Guro Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic University Of Korea St. Vincent's Hospital	Suwon-si	Kyonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyongsangnam-do
Mexico	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal
Mexico	Actualidad Basada en la Investigación del Cáncer	Guadalajara	Jalisco
Mexico	CIO - Centro de Inmuno-Oncología de Occidente	Guadalajara	Jalisco
Mexico	PanAmerican Clinical Research - Guadalajara	Guadalajara	Jalisco
Mexico	Renati Innovation	Guadalajara	Jalisco
Mexico	Health Pharma Querétaro	Juriquilla	Querétaro
Mexico	Preparaciones Oncológicas S.C.	León	Guanajuato
Mexico	Centro Onco-Hematológico Roma (COHR)	Mexico City	Distrito Federal
Mexico	Higiea Oncologia	Mexico City	Distrito Federal
Mexico	Avix Investigación Clinica, S.C.	Monterrey	Nuevo León
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Clinica Integral Internacional de Oncología	Puebla
Mexico	Oncare - Unidad Valle	San Pedro Garza García	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Netherlands	Jeroen Bosch ziekenhuis	Den Bosch	Noord-Brabant
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Medische Centrum Leeuwarden	Leeuwarden	Fryslân
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Erasmus Medisch Centrum	Rotterdam	Zuid-Holland
Netherlands	ETZ Elisabeth	Tilburg	Noord-Brabant
Netherlands	St. Antonius Ziekenhuis, locatie Utrecht	Utrecht
Norway	Haukeland Universitetssjukehus	Bergen	Hordaland
Norway	Drammen Sykehus, Vestre Viken HF	Drammen	Buskerud
Norway	Sykehuset Innlandet HF Gjøvik	Gjøvik	Oppland
Norway	Akershus Universitetssykehus	Lørenskog	Akershus
Norway	Oslo Universitetssykehus Ullevål	Oslo
Norway	Stavanger Universitetssykehus	Stavanger	Rogaland
Norway	St. Olavs Hospital	Trondheim	Sør-Trøndelag
Poland	Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Kielce	Swietokrzyskie
Poland	One Day Med	Szczecin	Zachodniopomorskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Portugal	Centro Hospitalar E Universitário De Coimbra	Coimbra
Portugal	Hospital da Luz Lisboa	Lisboa
Portugal	Champalimaud Foundation	Lisbon	Lisboa
Portugal	Hospital Pulido Valente	Lisbon	Lisboa
Portugal	Centro Hospitalar do Porto - Hospital de Santo António	Porto
Portugal	Hospital CUF Porto	Porto
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto
Romania	Lotus-Med	Bucharest	Bucuresti
Romania	Centrul medical Focus	Bucure?ti
Romania	Gral Medical Diagnostic Center	Bucure?ti
Romania	Institutul Oncologic	Cluj-Napoca	Cluj
Romania	Centrul de Oncologie "Sfântul Nectarie"	Craiova	Dolj
Romania	Ovidius Clinical Hospital OCH	Ovidiu	Constan?a
Romania	Cabinet Medical Oncomed	Timi?oara	Timi?
Romania	S C Oncocenter Oncologie Clinica S R L	Timi?oara	Timi?
Spain	CHUAC-Hospital Teresa Herrera	A Coruña	A Coruña [
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitari Dexeusa	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Parc de Salut Mar - Hospital del Mar	Barcelona	Barcelona [Barcelona]
Spain	Instituto Catalan de Oncologia - Hospital Duran i Reynals	Hospitalet de Llobregat	Barcelona [Barcelona]
Spain	Hospital Jerez de la Frontera	Jerez De La Frontera	Cádiz
Spain	Hospital Insular de Gran Canaria	Las Palmas de Gran Canaria	Las Palmas
Spain	Complejo Asistencial Universitario de León - Hospital de León	León	Castilla Y León
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Regional Universitario	Málaga
Spain	Hospital Universitari Son Espases	Palma De Mallorca	Balears [Baleares]
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruña [La Coruña]
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Clinico de Valencia	Valencia	Valenciana, Comunitat
Sweden	Västmanlands Sjukhus Västerås	Västerås	Västmanlands Län [se-19]
Switzerland	CHUV (centre hospitalier universitaire vaudois)	Lausanne	Vaud
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	UniversitätsSpital Zürich	Zürich
Taiwan	Changhua Christian Hospital	Changhua County	Changhua
Taiwan	Buddhist Dalin Tzu Chi General Hospital	Chiayi
Taiwan	National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region	Douliu City	Yunlin
Taiwan	Hualien Tzu Chi Medical Center	Hualien City	Hualien
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Hospital - Liouying Branch	Tainan City	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Cancer Center (NTUCC)	Taipei City	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Adana City Hospital	Adana
Turkey	Adana Medical Park Seyhan Hastanesi	Adana
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Ankara Etlik City Hospital	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Memorial Antalya Hospital	Antalya
Turkey	Uludag Universitesi	Bursa
Turkey	Dicle Üniversitesi	Diyarbakir
Turkey	Bezmialem Vakf Üniversitesi	Istanbul
Turkey	I.A.Ü VM Medical Park Florya Hastanesi	Istanbul
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Ege Universitesi Hastanesi	Izmir
Turkey	zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi	Izmir
Turkey	Kocaeli Üniversitesi	Kocaeli
Turkey	Ondokuz Mayis Universitesi	Samsun
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Aberdeen City
United Kingdom	Cheltenham General Hospital	Cheltenham	Gloucestershire
United Kingdom	Ninewells Hospital and Medical School	Dundee	Dundee City
United Kingdom	St James's University Hospital	Leeds
United Kingdom	The Christie NHS Foundation Trust	Manchester	Withington
United Kingdom	Mount Vernon Hospital	Northwood	Hillingdon
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	New Cross Hospital	Wolverhampton
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Hospital	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Cancer Institute	Durham	North Carolina
United States	Summit Health	Florham Park	New Jersey
United States	William Beaumont Army Medical Center	Fort Bliss	Texas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Millennium Oncology - Hollywood	Hollywood	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Community Cancer Center North	Indianapolis	Indiana
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Baptist Memorial Hospital-Memphis	Memphis	Tennessee
United States	Mercy UC Davis Cancer Center	Merced	California
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York
United States	Allina Health Cancer Institute	Minneapolis	Minnesota
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Laura and Isaac Perlmutter Cancer Center	New York	New York
United States	Manhattan Eye, Ear and Throat Hospital	New York	New York
United States	Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala	Ocala	Florida
United States	University of Oklahoma Health Sciences Center, Peggy and Charles Stephenson Oklahoma Cancer Center	Oklahoma City	Oklahoma
United States	The Valley Hospital	Paramus	New Jersey
United States	Capital Health Medical Center - Hopewell	Pennington	New Jersey
United States	Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Interstate Medical Office Central	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	UNC REX Cancer Center	Raleigh	North Carolina
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	HealthPartners Cancer Research Center	Saint Paul	Minnesota
United States	Comprehensive Hematology Oncology	Saint Petersburg	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Springfield Clinic Main Campus	Springfield	Illinois
United States	Tampa General Hospital	Tampa	Florida
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Clinical Research Alliance	Westbury	New York
United States	The University of Kansas Cancer Center - Westwood	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Part A and Part B: Overall Survival (OS)	Part A and Part B: OS	Randomization to date of death from any cause. (Estimated as up to 3 years)
Secondary	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)	ORR per RECIST v1.1 by BICR	Randomization to disease progression or death. (Estimated as approximately 1 year)
Secondary	Part A and Part B: Duration of Response (DOR)	DOR per RECIST v1.1 by BICR	Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year)
Secondary	Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)	DCR per RECIST v1.1 by BICR	Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)
Secondary	Part A and Part B: Time to Response (TTR)	TTR per RECIST v1.1 by BICR	Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year)
Secondary	Part A and Part B: PFS2	Part A and Part B: PFS2 by Investigator	Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year
Secondary	Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ)	NSCLC symptoms will be assessed using the 7-item NSCLC-SAQ. The NSCLC-SAQ measures overall symptom severity of NSCLC, including cough, pain, dyspnea, fatigue, and poor appetite. Response options range from 0) "Not at all" to 4) "Always" or from 0) "Never" to 4) "Always." The total score ranges from 0-20. Higher scores represent worse symptoms.	Randomization through end of treatment (Estimated as approximately 1 year)
Secondary	Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale	The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional health-related quality of life (HRQoL) in cancer patients. Physical functioning is measured by the EORTC-QLQ-30 Physical Function Scale (five items). Response options range from 1) "Not at all" to 4) "Very much." The sum score is linearly transformed to the range 0 - 100. Higher scores represent better physical function.	Randomization through end of treatment (Estimated as approximately 1 year)
Secondary	Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5)	FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. Response options range from 0) "Not at all" to 4) "Very much." Higher scores represent higher symptom burden.	Randomization through end of treatment (Estimated as approximately 1 year)
Secondary	Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale	The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 1) "very poor" to 7) "excellent." Scores are linearly transformed to the range 0 - 100. Higher scores represent better overall HRQoL.	Randomization through end of treatment (Estimated as approximately 1 year)

External Links

•   A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C (SUNRAY-01)