SUNRAY-01: 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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06119581

Collaborator

Loxo Oncology, Inc. (Industry)

1,016

Enrollment

218

Locations

Arms

68.9

Anticipated Duration (Months)

4.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis	Drug: LY3537982 Drug: Pembrolizumab Drug: Placebo Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1016 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 3, 2024

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab LY3537982 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.	Drug: LY3537982 Administered orally. Drug: Pembrolizumab Administered IV.
Experimental: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab LY3537982 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.	Drug: LY3537982 Administered orally. Drug: Pembrolizumab Administered IV.
Experimental: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum LY3537982 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.	Drug: LY3537982 Administered orally. Drug: Pembrolizumab Administered IV. Drug: Cisplatin Administered IV. Drug: Carboplatin Administered IV. Drug: Pemetrexed Administered IV.
Experimental: Part A: LY3537982 plus Pembrolizumab LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.	Drug: LY3537982 Administered orally. Drug: Pembrolizumab Administered IV.
Placebo Comparator: Part A: Placebo plus Pembrolizumab Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.	Drug: Pembrolizumab Administered IV. Drug: Placebo Administered orally.
Experimental: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum LY3537982 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.	Drug: LY3537982 Administered orally. Drug: Pembrolizumab Administered IV. Drug: Cisplatin Administered IV. Drug: Carboplatin Administered IV. Drug: Pemetrexed Administered IV.
Placebo Comparator: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum Placebo 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.	Drug: Pembrolizumab Administered IV. Drug: Placebo Administered orally. Drug: Cisplatin Administered IV. Drug: Carboplatin Administered IV. Drug: Pemetrexed Administered IV.

Outcome Measures

Primary Outcome Measures

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) [Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)]
Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE
Part A and Part B: Progression-Free Survival (PFS) [Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)]
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)

Secondary Outcome Measures

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: OS
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)]
ORR per RECIST v1.1 by BICR
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)]
DOR per RECIST v1.1 by BICR
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)]
DCR per RECIST v1.1 by BICR
Part A and Part B: Time to Response (TTR) [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)]
TTR per RECIST v1.1 by BICR
Part A and Part B: PFS2 [Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year]
Part A and Part B: PFS2 by Investigator
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) [Randomization through end of treatment (Estimated as approximately 1 year)]
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.
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 [Randomization through end of treatment (Estimated as approximately 1 year)]
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.
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) [Randomization through end of treatment (Estimated as approximately 1 year)]
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.
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 [Randomization through end of treatment (Estimated as approximately 1 year)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Arizona Cancer Center - North Campus	Tucson	Arizona	United States	85719
2	Mercy UC Davis Cancer Center	Merced	California	United States	95340
3	Millennium Oncology - Hollywood	Hollywood	Florida	United States	33024
4	University of Miami Hospital and Clinics, Sylvester Cancer Center	Miami	Florida	United States	33136
5	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida	United States	33176
6	Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala	Ocala	Florida	United States	34474
7	Comprehensive Hematology Oncology	Saint Petersburg	Florida	United States	33709
8	Tampa General Hospital	Tampa	Florida	United States	33606
9	Winship Cancer Institute, Emory University	Atlanta	Georgia	United States	30322
10	University of Illinois at Chicago	Chicago	Illinois	United States	60612
11	Boston Medical Center	Boston	Massachusetts	United States	02118
12	University of Michigan	Ann Arbor	Michigan	United States	48109
13	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan	United States	49503
14	Allina Health Cancer Institute	Minneapolis	Minnesota	United States	55407
15	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
16	Regional Cancer Care Associates	Freehold	New Jersey	United States	07728
17	Capital Health Medical Center - Hopewell	Pennington	New Jersey	United States	08534
18	The Valley Hospital	Ridgewood	New Jersey	United States	07450
19	Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York	United States	11501
20	Laura and Isaac Perlmutter Cancer Center	New York	New York	United States	10016
21	Manhattan Eye, Ear and Throat Hospital	New York	New York	United States	10065
22	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
23	Clinical Research Alliance	Westbury	New York	United States	11590
24	Asante Rogue Regional Medical Center	Medford	Oregon	United States	97504
25	Providence Portland Medical Center	Portland	Oregon	United States	97213
26	Tidelands Health Oncology	Murrells Inlet	South Carolina	United States	29576
27	William Beaumont Army Medical Center	Fort Bliss	Texas	United States	79918
28	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
29	The University of Vermont Medical Center Inc.	Burlington	Vermont	United States	05401
30	Kadlec Clinic Hematology and Oncology	Kennewick	Washington	United States	99336
31	Virginia Mason Medical Center	Seattle	Washington	United States	98101
32	VA Puget Sound Health Care System	Seattle	Washington	United States	98108
33	Icon Cancer Centre Wesley	Auchenflower	Queensland	Australia	4066
34	Goulburn Valley Health	Shepparton	Victoria	Australia	3630
35	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Kärnten	Austria	9020
36	Landeskrankenhaus Feldkirch	Feldkirch	Vorarlberg	Austria	6800
37	Klinik Floridsdorf	Wien		Austria	1210
38	ZNA Middelheim	Antwerp	Antwerpen	Belgium	2020
39	AZ Sint-Maarten, Campus Leopoldstraat 2	Mechelen	Antwerpen	Belgium	2800
40	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne	Yvoir	Namur	Belgium	5000
41	UZ Gent	Gent	Oost-Vlaanderen	Belgium	9000
42	Clinique Saint Pierre	Ottignies		Belgium	1340
43	AZ Glorieux Ronse	Ronse		Belgium	9600
44	Centro de Pesquisa Clínica do Instituto do Câncer do Ceará	Fortaleza	Ceará	Brazil	60430235
45	Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul	Brasilia	Distrito Federal	Brazil	70200-730
46	Hospital Brasilia	Lago sul	Distrito Federal	Brazil	71635580
47	Hospital São Domingos	Bequimao	Maranhão	Brazil	65060-645
48	Oncominas	Pouso Alegre	Minas Gerais	Brazil	37554-216
49	Hospital de Cancer de Londrina	Londrina	Paraná	Brazil	86015-520
50	Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande Do Norte	Brazil	59062-000
51	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	Rio Grande Do Sul	Brazil	98700-000
52	Faculdade de Medicina do ABC	Santo André	São Paulo	Brazil	09060-650
53	Hospital Paulistano	Sao Paulo	São Paulo	Brazil	01321-001
54	COE Ensino e Pesquisa	São José dos Campos	São Paulo	Brazil	12242-660
55	Hospital São Lucas da PUCRS	Porto Alegre		Brazil	90610
56	Instituto Nacional de Câncer - INCA	Rio de Janeiro		Brazil	20231-050
57	Grupo Oncoclínicas Botafogo	Rio de Janeiro		Brazil	22250-905
58	Icesp - Instituto Do Câncer Do Estado de São Paulo	São Paulo		Brazil	01246-000
59	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo		Brazil	04014-002
60	Instituto de Assist├ncia M├dica ao Servidor P	São Paulo		Brazil	04039-901
61	Hamilton Health Sciences-Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V5C2
62	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec	Canada	G7H 5H6
63	Wannan Medical College Yijishan Hospital	Wuhu	Anhui	China	241001
64	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing	China	100021
65	Beijing Cancer hospital	Beijing	Beijing	China	100142
66	The First Affiliated Hospital of the Third Military Medical University	Shapingba	Chongqing	China	400038
67	Fujian Provincial Cancer Hospital	Fuzhou	Fujian	China	350014
68	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
69	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong	China	524004
70	Liuzhou People's Hospital	Liuzhou	Guangxi	China	545006
71	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
72	Wuhan Union Hospital	Wuhan	Hubei	China	430022
73	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei	China	430030
74	Xiangya Hospital Central South University	Changsha	Hunan	China	410008
75	Hunan Cancer Hospital	Changsha	Hunan	China	410013
76	Hunan Cancer Hospital	Changsha	Hunan	China	410013
77	ZhuZhou Central Hospital	Zhuzhou	Hunan	China	412007
78	Nanjing First Hospital	Nanjing	Jiangsu	China	210012
79	Nantong Tumor Hospital	Nantong	Jiangsu	China	226361
80	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
81	Jilin Cancer Hospital	Changchun	Jilin	China	132000
82	Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army	Xi'an	Shaanxi	China	710038
83	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
84	Shanghai Chest Hospital	Shanghai	Shanghai	China	200030
85	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
86	Zhongshan Hospital,Fudan University	Shanghai	Shanghai	China	200032
87	West China Hospital of Sichuan University	Cheng Du	Sichuan	China	610041
88	The Third People's Hospital of Chengdu (CDTPH)	Chengdu	Sichuan	China	610031
89	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060
90	The First Affiliated Hospital of Xinjiang Medical University	Urumchi	Xinjiang	China	830054
91	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang	China	310003
92	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310016
93	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022
94	Hwa Mei Hospital University of Chinese Academy of Sciences	Ningbo	Zhejiang	China	315099
95	Yichang Central People's Hospital	Yichang		China	443003
96	Nemocnice AGEL Ostrava - Vitkovice a.s.	Ostrava	Ostrava Mě	Czechia	703 84
97	Centre Antoine-Lacassagne	Nice	Alpes-Maritimes	France	06189
98	Institut de Cancérologie de l'Ouest	Saint Herblain	Loire-Atlantique	France	44805
99	Centre Hospitalier intercommunal de Toulon La Seyne sur Mer	Toulon	Provence-Alpes-Côte-d'Azur	France	83100
100	Sainte Catherine Institut du Cancer Avignon Provence	Avignon	Vaucluse	France	84918
101	Institut Curie	Paris		France	75248
102	Asklepios Fachkliniken München-Gauting	Gauting	Bayern	Germany	82131
103	Hämato-Onkologie Hamburg, Prof. Laack und Partner	Hamburg		Germany	20251
104	University Hospital of Patras	Patras	Achaḯa	Greece	26504
105	Agios Savvas Regional Cancer Hospital	Athens	Attikí	Greece	115 22
106	Errikos Dunant Hospital Center	Athens	Attikí	Greece	115 26
107	Sotiria Thoracic Diseases Hospital of Athens	Athens	Attikí	Greece	115 27
108	University General Hospital of Heraklion	Heraklion	Irakleío	Greece	715 00
109	European Interbalkan Medical Center	Thessaloniki	Thessaloníki	Greece	570 01
110	G. Papanikolaou General Hospital	Thessaloniki	Thessaloníki	Greece	570 10
111	Onkoradiologiai Kozpont	Kecskemét	Bács-Kiskun	Hungary	6000
112	Rajiv Gandhi Cancer Institute And Research Centre	New Delhi	Delhi	India	110085
113	SRV Hospitals	Bengaluru	Karnataka	India	560027
114	Regional Cancer Centre - Thiruvananthapuram	Thiruvananthapuram	Kerala	India	695011
115	Krishna Institute of Medical Sciences - Karad	Karad	Maharashtra	India	415539
116	Sahyadri Super Speciality Hospital	Pune	Maharashtra	India	411004
117	Ashwin Hospital	Coimbatore	Tamil Nadu	India	641012
118	Nizam's Institute of Medical Sciences	Hyderabad	Telangana	India	500082
119	Tata Memorial Centre - Homi Bhabha Cancer Hospital	Varanasi	Uttar Pradesh	India	221002
120	Banaras Hindu University	Varanasi	Uttar Pradesh	India	221005
121	Postgraduate Institute of Medical Education & Research	Chandigarh		India	160012
122	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli	Campania	Italy	80131
123	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan	Lombardia	Italy	20133
124	Istituto Nazionale Tumori Regina Elena	Rome	Roma	Italy	00144
125	Policlinico "G. Rodolico"	Catania	Sicilia	Italy	95123
126	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona	Veneto	Italy	37126
127	Istituto Oncologico Veneto IRCCS	Padova		Italy	35128
128	Aichi Cancer Center Hospital	Nagoya	Aichi	Japan	464-8681
129	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
130	Niigata Cancer Center Hospital	Niigata	Hokkaido	Japan	951-8566
131	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
132	Himeji Medical Center	Himeji	Hyogo	Japan	670-8520
133	Kanazawa University Hospital	Kanazawa	Ishikawa	Japan	920-8641
134	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa	Japan	236-0051
135	Hikita Pediatric clinic	Yokohama	Kanagawa	Japan	2418515
136	Miyagi Cancer Center	Natori	Miyagi	Japan	981-1293
137	Kansai Medical University Hospital	Hirakata	Osaka	Japan	573-1191
138	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai	Osaka	Japan	591-8555
139	Saitama Medical University International Medical Center	Hidaka	Saitama	Japan	350-1298
140	Juntendo University Hospital	Bunkyo-ku	Tokyo	Japan	113-8431
141	Japanese Foundation for Cancer Research	Koto	Tokyo	Japan	135-8550
142	National Hospital Organization Yamaguchi Ube Medical Center	Ube	Yamaguchi	Japan	755-0241
143	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
144	University Hospital,Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
145	Okayama University Hospital	Okayama		Japan	700-8558
146	Wakayama Medical University Hospital	Wakayama		Japan	641-8510
147	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do [Chungbuk]	Korea, Republic of	28644
148	Chonnam National University Hwasun Hospital	Hwasun	Jeonranamdo	Korea, Republic of	58128
149	National Cancer Center	Goyang-si	Kyǒnggi-do	Korea, Republic of	10408
150	Gangnam Severance Hospital	Gangnam-gu	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	06273
151	Gangnam Severance Hospital	Gangnam-gu	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	06273
152	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	02841
153	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	03722
154	Hanyang University Seoul Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	04763
155	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	05505
156	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	07345
157	Korea University Guro Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	08308
158	Keimyung University Dongsan Hospital	Daegu	Taegu-Kwangyǒkshi	Korea, Republic of	42601
159	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal	Mexico	03100
160	Centro Onco-Hematológico Roma (COHR)	Mexico City	Distrito Federal	Mexico	06700
161	Higiea Oncologia	Mexico City	Distrito Federal	Mexico	11819
162	Preparaciones Oncológicas S.C.	León	Guanajuato	Mexico	37178
163	CIO - Centro de Inmuno-Oncología de Occidente	Guadalajara	Jalisco	Mexico	44630
164	PanAmerican Clinical Research - Guadalajara	Guadalajara	Jalisco	Mexico	44670
165	Actualidad Basada en la Investigación del Cáncer	Guadalajara	Jalisco	Mexico	44680
166	Renati Innovation	Guadalajara	Jalisco	Mexico	44680
167	Avix Investigación Clinica, S.C.	Monterrey	Nuevo León	Mexico	64710
168	Oncare - Unidad Valle	San Pedro Garza García	Nuevo León	Mexico	66220
169	Health Pharma Querétaro	Juriquilla	Querétaro	Mexico	76230
170	Centro de Investigacion Clinica de Oaxaca	Oaxaca		Mexico	68020
171	Clinica Integral Internacional de Oncología	Puebla		Mexico	72530
172	Arké SMO S.A de C.V	Veracruz		Mexico	91910
173	ETZ Elisabeth	Tilburg	Noord-Brabant	Netherlands	5022 GC
174	Medisch Spectrum Twente	Enschede	Overijssel	Netherlands	7512 KZ
175	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland	Netherlands	2333 ZA
176	Drammen Sykehus, Vestre Viken HF	Drammen	Buskerud	Norway	3004
177	Stavanger Universitetssykehus	Stavanger	Rogaland	Norway	4011
178	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie	Poland	87-100
179	Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Kielce	Świętokrzyskie	Poland	25-734
180	Hospital Pulido Valente	Lisbon	Lisboa	Portugal	1769-001
181	Centro Hospitalar E Universitário De Coimbra	Coimbra		Portugal	3040
182	Hospital CUF Porto	Porto		Portugal	4100-180
183	Centrul de Oncologie "Sfântul Nectarie"	Craiova	Dolj	Romania	200542
184	S C Oncocenter Oncologie Clinica S R L	Timișoara	Timiș	Romania	300166
185	Cabinet Medical Oncomed	Timișoara	Timiș	Romania	300239
186	Centrul medical Focus	București		Romania	022548
187	Gral Medical Diagnostic Center	București		Romania	031422
188	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruña [La Coruña]	Spain	15706
189	Parc de Salut Mar - Hospital del Mar	Barcelona	Barcelona [Barcelona]	Spain	08003
190	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]	Spain	8035
191	Hospital Universitari Dexeusa	Barcelona	Catalunya [Cataluña]	Spain	08028
192	Instituto Catalan de Oncologia - Hospital Duran i Reynals	L'Hospitalet de Llobregat	Catalunya [Cataluña]	Spain	8907
193	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De	Spain	28041
194	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid	Spain	28223
195	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31009
196	Hospital Infanta Cristina	Badajoz		Spain	06006
197	Hospital Universitario Virgen Del Rocio	Sevilla		Spain	41013
198	Akademiska sjukhuset	Uppsala	Uppsala Län [se-03]	Sweden	751 85
199	Västmanlands Sjukhus Västerås	Västerås	Västmanlands Län [se-19]	Sweden	721 89
200	Changhua Christian Hospital	Changhua County	Changhua	Taiwan	50006
201	Hualien Tzu Chi Medical Center	Hualien City	Hualien	Taiwan	970
202	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung	Taiwan	83301
203	Chung Shan Medical University Hospital	Taichung City	Taichung	Taiwan	402
204	Chi Mei Hospital - Liouying Branch	Tainan City	Tainan	Taiwan	73657
205	National Taiwan University Cancer Center (NTUCC)	Taipei City	Taipei	Taiwan	106
206	Taipei Veterans General Hospital	Taipei City	Taipei	Taiwan	112
207	National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region	Douliu City	Yunlin	Taiwan	640
208	National Taiwan University Hospital	Taipei City	Zhongzheng District	Taiwan	10002
209	Buddhist Dalin Tzu Chi General Hospital	Chiayi		Taiwan	622
210	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
211	Taichung Veterans General Hospital	Taichung		Taiwan	407
212	National Cheng Kung University Hospital	Tainan		Taiwan	704
213	Chang Gung Medical Foundation-Linkou Branch	Taoyuan		Taiwan	333
214	Cheltenham General Hospital	Cheltenham	Gloucestershire	United Kingdom	GL53 7AN
215	Mount Vernon Hospital	Northwood	Hillingdon	United Kingdom	HA6 2RN
216	The Christie NHS Foundation Trust	Manchester	Withington	United Kingdom	M20 4 BX
217	St James's University Hospital	Leeds		United Kingdom	LS9 7TF
218	New Cross Hospital	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

Eli Lilly and Company
Loxo Oncology, Inc.

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT06119581

Other Study ID Numbers:

18612
J3M-MC-JZQB
U1111-1288-0565
2023-503412-33-00

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 7, 2023