EMBER-3: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04975308
Collaborator
(none)
800
239
3
59.3
3.3
0.1
Study Details
Study Description
Brief Summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Actual Study Start Date
:
Oct 4, 2021
Anticipated Primary Completion Date
:
Jun 13, 2023
Anticipated Study Completion Date
:
Sep 13, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Imlunestrant Imlunestrant administered orally. |
Drug: Imlunestrant
Administered orally.
Other Names:
|
| Active Comparator: Investigator's Choice of Endocrine Therapy Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). |
Drug: Exemestane
Administered orally.
Drug: Fulvestrant
Administered IM.
|
| Experimental: Imlunestrant plus Abemaciclib Imlunestrant plus abemaciclib administered orally. |
Drug: Imlunestrant
Administered orally.
Other Names:
Drug: Abemaciclib
Administered orally.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)]
PFS by investigator assessment
Secondary Outcome Measures
- Overall Survival (OS) [Randomization until death from any cause (estimated as up to 5 years)]
OS
- Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [Randomization until measured progressive disease (estimated as up to 1 year)]
ORR
- Duration of Response (DoR) [Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)]
DoR
- Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [Randomization until measured progressive disease (estimated as up to 1 year)]
CBR
- PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma [Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)]
Investigator-assessed PFS by ESR1 mutation status in plasma
- Progression Free Survival (PFS) [Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)]
PFS by blinded independent review
- Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" [Screening through follow-up (estimated as up to 3 years)]
Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."
- Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant [Cycle 2 to Cycle 4 (cycle = 28 days)]
PK: steady state plasma concentrations of imlunestrant
- PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib [Cycle 2 to Cycle 4 (cycle = 28 days)]
PK: steady state plasma concentrations of imlunestrant and abemaciclib
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
-
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
-
Must be deemed appropriate for treatment with endocrine therapy
-
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
-
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
-
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
-
Have adequate renal, hematologic, and hepatic organ function
-
Must be able to swallow capsules/tablets
Exclusion Criteria:
-
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
-
Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
-
Have symptomatic or untreated brain metastasis.
-
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
-
Known allergic reaction against any of the components of the study treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ironwood Cancer & Research Centers | Chandler | Arizona | United States | 85224 |
| 2 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 3 | Marin Cancer Care | Greenbrae | California | United States | 94904 |
| 4 | University of California, Davis - Health Systems | Sacramento | California | United States | 95817 |
| 5 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
| 6 | Banner MD Anderson Cancer Center at North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 7 | Rocky Mountain Cancer Center | Lone Tree | Colorado | United States | 80124 |
| 8 | Banner MD Anderson Cancer Center at McKee Medical Center | Loveland | Colorado | United States | 80538 |
| 9 | Univ of Florida School of Medicine | Gainesville | Florida | United States | 32610 |
| 10 | Florida Cancer Specialists | Saint Petersburg | Florida | United States | 33705 |
| 11 | Florida Cancer Specialists | Sarasota | Florida | United States | 34232 |
| 12 | Florida Cancer Specialists | West Palm Beach | Florida | United States | 33401 |
| 13 | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | United States | 96819 |
| 14 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 15 | University of Chi Med Center | Chicago | Illinois | United States | 60637 |
| 16 | IU Health Ball Memorial Hospital, Inc. | Muncie | Indiana | United States | 47303 |
| 17 | The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 18 | Minnesota Oncology/Hematology PA | Coon Rapids | Minnesota | United States | 55433 |
| 19 | Jackson Oncology Associates, PLLC | Jackson | Mississippi | United States | 39202 |
| 20 | Care Access - Clifton | Clifton | New Jersey | United States | 07013 |
| 21 | The Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 22 | Broome Oncology | Binghamton | New York | United States | 13905 |
| 23 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 24 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 25 | University of North Carolina Medical Center | Chapel Hill | North Carolina | United States | 27599 |
| 26 | Aultman Hospital | Canton | Ohio | United States | 44710 |
| 27 | Zangmeister Cancer Center | Columbus | Ohio | United States | 43219 |
| 28 | Willamette Valley Cancer Institute & Research Ctr. | Eugene | Oregon | United States | 97401 |
| 29 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 30 | Sarah Cannon Research Institute SCRI | Nashville | Tennessee | United States | 37203 |
| 31 | Texas Oncology - Austin Central | Austin | Texas | United States | 78731 |
| 32 | Texas Oncology - Carrollton | Carrollton | Texas | United States | 75010 |
| 33 | Texas Oncology - Methodist Charlton Cancer Center | Dallas | Texas | United States | 75203 |
| 34 | Texas Oncology - Medical City Dallas | Dallas | Texas | United States | 75230 |
| 35 | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | United States | 75231 |
| 36 | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 37 | Texas Oncology - Denison | Denison | Texas | United States | 75020 |
| 38 | Texas Oncology Denton | Denton | Texas | United States | 76201 |
| 39 | Texas Oncology Fort Worth | Fort Worth | Texas | United States | 76104 |
| 40 | Texas Oncology - Willowbrook | Houston | Texas | United States | 77070 |
| 41 | Texas Oncology - McKinney | McKinney | Texas | United States | 75071 |
| 42 | Texas Oncology - Paris | Paris | Texas | United States | 75460 |
| 43 | Texas Oncology-Plano East | Plano | Texas | United States | 75075 |
| 44 | Texas Oncology - San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
| 45 | Texas Oncology - The Woodlands | The Woodlands | Texas | United States | 77380 |
| 46 | US Oncology | The Woodlands | Texas | United States | 77380 |
| 47 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
| 48 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 49 | Blue Ridge Cancer Care | Salem | Virginia | United States | 24153 |
| 50 | Fundación CENIT para la Investigación en Neurociencias | Caba | BA | Argentina | C1125ABD |
| 51 | Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | Buenos Aires | Argentina | 7600 |
| 52 | CIPREC | Ciudad Autonoma de Buenos Aire | Ciudad Autónoma De Buenos Aire | Argentina | C1119ACN |
| 53 | Clinica Viedma S. A | Viedma | Río Negro | Argentina | R8500ACE |
| 54 | Instituto Argentino de Diagnóstico y Tratamiento (IADT) | Buenos Aires | Argentina | 1122 | |
| 55 | Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC | Cordoba | Argentina | X5008HHW | |
| 56 | Instituto San Marcos | San Juan | Argentina | 5400 | |
| 57 | Sanatorio Norte | Santiago del Estero | Argentina | 4200 | |
| 58 | St Vincent's Hospital | Darlinghurst | New South Wales | Australia | 2010 |
| 59 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | 4102 |
| 60 | Cancer Research SA | Adelaide | South Australia | Australia | 5000 |
| 61 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 62 | Maroondah Hospital | Melbourne | Victoria | Australia | 3135 |
| 63 | Universitätsklinikum Graz | Graz | Steiermark | Austria | 8036 |
| 64 | Private Practice - Dr. Hubalek | Schwaz | Tirol | Austria | 6130 |
| 65 | Medizinische Universität Wien | Vienna | Wien | Austria | 1090 |
| 66 | Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
| 67 | Imelda General Hospital | Bonheiden | Antwerpen | Belgium | 2820 |
| 68 | UZ Brussel | Brussels | Bruxelles-Capitale, Région De | Belgium | 1090 |
| 69 | UZ Gent | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 70 | VITAZ | Sint-Niklaas | Oost-Vlaanderen | Belgium | B-9100 |
| 71 | AZ Groeninge Campus Kennedylaan | Kortrijk | West-Vlaanderen | Belgium | 8500 |
| 72 | Institut Jules Bordet | Brussels-Capital | Belgium | 1070 | |
| 73 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 74 | Hospital de Cancer de Londrina | Londrina | Paraná | Brazil | 86015-520 |
| 75 | Faculdade de Medicina do ABC | Santo Andre | SP | Brazil | 09060-650 |
| 76 | Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | Brazil | 01246-000 | |
| 77 | Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA | São Paulo | Brazil | 01317-001 | |
| 78 | IBCC - Instituto Brasileiro de Controle do Câncer | São Paulo | Brazil | 04014-002 | |
| 79 | Afflilated Hospital of Bengbu Medical College | Bengbu | Anhui | China | 233004 |
| 80 | Beijing Hospital | Beijing | Beijing | China | 100005 |
| 81 | The Fifth Medical Center of PLA General Hospital | Beijing | Beijing | China | 100071 |
| 82 | Beijing Cancer hospital | Beijing | Beijing | China | 100142 |
| 83 | Sun Yat-Sen University Cancer Centre | Guangzhou | Guangdong | China | 511400 |
| 84 | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China | 150081 |
| 85 | The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Henan | China | 471003 |
| 86 | People's Hospital of Henan Province | Zhengzhou | Henan | China | 450003 |
| 87 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
| 88 | Hubei Cancer Hospital | Wuhan | Hubei | China | 430079 |
| 89 | The First People's Hospital of Changde City | Changde | Hunan | China | 415003 |
| 90 | Hunan Provincial People's Hospital | ChangSha | Hunan | China | 410005 |
| 91 | Xiangya Hospital Central South University | Changsha | Hunan | China | 410008 |
| 92 | Hunan Cancer Hospital | Changsha | Hunan | China | 421000 |
| 93 | The Third Hospital of Nanchang | Nanchang | Jiangxi | China | 330009 |
| 94 | The Second Hospital of Jilin University | Changchun | Jilin | China | 130000 |
| 95 | The First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
| 96 | Jiangsu Province Hospital | Nanjing | Nanjing | China | 210029 |
| 97 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
| 98 | Jinan Central Hospital | Jinan | Shandong | China | 250013 |
| 99 | Yantai Yuhuangding Hospital | Yantai | Shandong | China | 264000 |
| 100 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | |
| 101 | Xinjiang Medical University Cancer Hospital - Urumqi | Urumqi | Xinjiang | China | 830000 |
| 102 | The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
| 103 | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China | 310016 |
| 104 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
| 105 | Hwa Mei Hospital University of Chinese Academy of Sciences | Ningbo | Zhejiang | China | 315010 |
| 106 | Sichuan Cancer Hospital | Chengdu | China | 610041 | |
| 107 | Jining Medical University - Affiliated Hospital | Jining | China | 272029 | |
| 108 | Wu Han Tongji Hospital | Wuhan | China | 430030 | |
| 109 | Thomayerova nemocnice | Praha | Praha 4 - Krč | Czechia | 14059 |
| 110 | Nemocnice Na Bulovce | Prague | Praha 8 | Czechia | 180 81 |
| 111 | Nemocnice Horovice | Horovice | Czechia | 268 01 | |
| 112 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 100 34 | |
| 113 | Oblastní nemocnice Příbram, a.s. | Pribram | Czechia | 261 01 | |
| 114 | Institut de cancérologie Strasbourg Europe (ICANS) | Strasbourg | Alsace | France | 67033 |
| 115 | CHU Besançon | Besançon | Doubs | France | 25000 |
| 116 | Centre de Cancérologie du Grand Montpellier | Montpellier | Languedoc-Roussillon | France | 34070 |
| 117 | Institut de Cancérologie de Lorraine Alexis Vautrin | Vandoeuvre-lès-Nancy | Lorraine | France | 54519 |
| 118 | Centre Hospitalier de la Côte Basque | Bayonne | Pyrénées-Atlantiques | France | 64109 |
| 119 | Polyclinique De Blois | La Chaussee Saint Victor | France | 41260 | |
| 120 | Clinique Victor Hugo - Centre Jean Bernard | Le Mans | France | 72000 | |
| 121 | Institut Curie | Paris | France | 75248 | |
| 122 | Institut Curie | Saint-Cloud | Île-de-France | France | 92210 |
| 123 | Klinikum Ludwigsburg | Ludwigsburg | Baden-Württemberg | Germany | 71640 |
| 124 | Universitätsklinikum Erlangen | Erlangen | Bayern | Germany | 91054 |
| 125 | Klinikum der Ludwig-Maximilians-Universitaet Muenchen | München | Bayern | Germany | 80337 |
| 126 | Agaplesion Markus Krankenhaus | Frankfurt | Hessen | Germany | 60431 |
| 127 | Gynäkologisch-Onkologische Praxis am Pelikanplatz | Hannover | Niedersachsen | Germany | 30177 |
| 128 | Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung | Essen | Nordrhein-Westfalen | Germany | 45136 |
| 129 | Evangelisches Krankenhaus Bethesda Mönchengladbach | Mönchengladbach | Nordrhein-Westfalen | Germany | 41061 |
| 130 | Universitaetsklinikum Schleswig-Holstein Campus Kiel | Kiel | Schleswig-Holstein | Germany | 24105 |
| 131 | Agios Savvas Regional Cancer Hospital | Athens | Attikí | Greece | 115 22 |
| 132 | Alexandra General Hospital of Athens | Athens | Attikí | Greece | 11528 |
| 133 | General Oncology Hospital of Kifissia "Agioi Anargiroi" | Nea Kifissia | Attikí | Greece | 14564 |
| 134 | University General Hospital of Heraklion | Heraklion | Irakleío | Greece | 711 10 |
| 135 | Euromedica General Clinic of Thessaloniki | Thessaloniki | Thessaloníki | Greece | 546 45 |
| 136 | European Interbalkan Medical Center | Thessaloniki | Thessaloníki | Greece | 570 01 |
| 137 | General Hospital of Thessaloniki Papageorgiou | Thessaloniki | Greece | 56403 | |
| 138 | Maulana Azad Medical College | New Delhi | Delhi | India | 110002 |
| 139 | HCG-Bangalore | Bengaluru | Karnataka | India | 560027 |
| 140 | Regional Cancer Centre - Thiruvananthapuram | Thiruvananthapuram | Kerala | India | 695011 |
| 141 | HCG Cancer Centre | Mumbai | Maharashtra | India | 400092 |
| 142 | Government Medical College And Hospital - Nagpur | Nagpur | Maharashtra | India | 440003 |
| 143 | HCG Manavata Cancer Centre | Nashik | Maharashtra | India | 422001 |
| 144 | Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | India | 411004 |
| 145 | Yashoda Hospitals | Hyderabad | Telangana | India | 500082 |
| 146 | University of Naples Federico II | Naples | Campania | Italy | 80100 |
| 147 | Istituto Nazionale Tumori IRCCS Fondazione Pascale | Napoli | Campania | Italy | 80131 |
| 148 | Cro-Irccs | Aviano | Friuli-Venezia Giulia | Italy | 33081 |
| 149 | Fondazione Policlinico Universitario Agostino Gemelli | Roma | Lazio | Italy | 00168 |
| 150 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardia | Italy | 20133 |
| 151 | Azienda Ospedaliera Universitaria Careggi | Firenze | Toscana | Italy | 50134 |
| 152 | Ospedale San Martino | Genova | Italy | 16132 | |
| 153 | Istituto Europeo di Oncologia IRCCS | Milano | Italy | 20141 | |
| 154 | Azienda Ospedaliero Universitaria | Modena | Italy | 41125 | |
| 155 | Istituto Oncologico Veneto IRCCS | Padova | Italy | 35128 | |
| 156 | Nagoya University Hospital | Nagoya | Aichi | Japan | 466-8560 |
| 157 | Chiba cancer center | Chiba-shi | Chiba | Japan | 260-8717 |
| 158 | National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | Japan | 791-0280 |
| 159 | Kurume General Hospital | Kurume | Fukuoka | Japan | 830-0013 |
| 160 | Gunma Prefectural Cancer Center | Ota | Gunma | Japan | 373-0828 |
| 161 | National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | Japan | 003-0804 |
| 162 | Hyogo Cancer Center | Akashi | Hyogo | Japan | 673-8558 |
| 163 | University of tsukuba hospital | Tsukuba-shi | Ibaragi | Japan | 305-8576 |
| 164 | St. Marianna University Hospital | Kawasaki | Kanagawa | Japan | 216-8511 |
| 165 | Kanagawa cancer center | Yokohama | Kanagawa | Japan | 241-8515 |
| 166 | Niigata Cancer Center Hospital | Niigata-shi | Niigata | Japan | 951-8566 |
| 167 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 168 | National Cancer Center Hospital | Chuo-ku | Tokyo | Japan | 104-0045 |
| 169 | Showa University Hospital | Shinagawa | Tokyo | Japan | 142-8555 |
| 170 | National Hospital Organization Kyushu Cancer Center | Fukuoka | Japan | 811-1395 | |
| 171 | Hiroshima City Hospital | Hiroshima | Japan | 730-8518 | |
| 172 | Sagara Hospital | Kagoshima | Japan | 892-0833 | |
| 173 | Kumamoto Shinto General Hospital | Kumamoto | Japan | 862-8655 | |
| 174 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
| 175 | Shizuoka Prefectural General Hospital | Shizuoka | Japan | 420-0881 | |
| 176 | Soon Chun Hyang University Cheonan Hospital | Cheonan-si | Chungcheongnam-do [Chungnam] | Korea, Republic of | 31151 |
| 177 | Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [Incheon] | Korea, Republic of | 21565 |
| 178 | Severance Hospital, Yonsei University Health System | Seoul | Korea | Korea, Republic of | 03722 |
| 179 | Ajou University Hospital | Suwon-si | Kyǒnggi-do | Korea, Republic of | 16499 |
| 180 | Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | Korea, Republic of | 42415 |
| 181 | Dong-A University Hospital | Busan | Pusan-Kwangyǒkshi | Korea, Republic of | 49201 |
| 182 | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03080 |
| 183 | Kangbuk Samsung Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03181 |
| 184 | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 05505 |
| 185 | Gangnam Severance Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 06273 |
| 186 | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 06351 |
| 187 | Centro de Investigación Clínica de Alta Especialidad | Torreón | Coahuila | Mexico | 27010 |
| 188 | Grupo Medico Camino Sc | Mexico City | Distrito Federal | Mexico | 03310 |
| 189 | Christus Muguerza Clinica Vidriera (Christus Muguerza Sistemas Hospitalarios S.A. de C.V.) | Monterrey Nuevo León, C.P. | Monterrey | Mexico | 64570 |
| 190 | COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F. | Paso De Las Lomas | MX | Mexico | 01330 |
| 191 | Private Practice - Dr. Joaquin Reinoso | Monterrey | Nuevo León | Mexico | 64320 |
| 192 | Centro Medico Zambrano Hellion | San Pedro Garza Garcia | Nuevo León | Mexico | 66278 |
| 193 | Unidad de Investigación en Salud | Chihuahua | Mexico | 31203 | |
| 194 | Oaxaca Site Management Organization | Oaxaca | Mexico | 68000 | |
| 195 | Unidad Médica Onco-hematológica | Puebla | Mexico | 72424 | |
| 196 | Medische Centrum Leeuwarden | Leeuwarden | Fryslân | Netherlands | 8934 AD |
| 197 | Maastricht UMC+ | Maastricht | Limburg | Netherlands | 6229 HX |
| 198 | Haga Ziekenhuis locatie Leyweg | Den Haag | Zuid-Holland | Netherlands | 2545 AA |
| 199 | N.N.Petrov Research Institute of Oncology | St. Petersburg | Peterburg | Russian Federation | 197758 |
| 200 | Volgograd Regional Clinical Cancer Clinic No.1 | Volgograd | Volgogradskaya Oblast' | Russian Federation | 400138 |
| 201 | SHI Kaluga Regional Hospital | Kaluga | Russian Federation | 248007 | |
| 202 | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | Spain | 08035 |
| 203 | Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] | Spain | 08041 |
| 204 | Hospital Universitari Arnau de Vilanova | Lleida | Cataluña | Spain | 25198 |
| 205 | Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad De | Spain | 28034 |
| 206 | Hospital Universitario de Canarias | La Laguna | Santa Cruz De Tenerife | Spain | 38320 |
| 207 | Hospital Universitario San Cecilio | Granada | Spain | 18016 | |
| 208 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 209 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 210 | Hospital Universitario Virgen Del Rocio | Sevilla | Spain | 41013 | |
| 211 | Hospital Clínico Universitario de Valencia | Valencia | Spain | 46010 | |
| 212 | Hospital Quirón Salud Valencia | Valencia | Spain | 46010 | |
| 213 | Chi Mei Hospital - Liouying Branch | Tainan City | Tainan | Taiwan | 73657 |
| 214 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705, ROC | |
| 215 | National Cheng-Kung Uni. Hosp. | Tainan | Taiwan | 704 | |
| 216 | National Taiwan University Hospital | Taipei | Taiwan | 10002 | |
| 217 | Koo Foundation Sun Yat-Sen Cancer Center | Taipei | Taiwan | 112 | |
| 218 | Acibadem Altunizade Hospital | Üsküdar / Stanbul | İstanbul | Turkey | |
| 219 | Ege University Medicine of Faculty | Bornova | İzmir | Turkey | 35100 |
| 220 | Baskent University Dr. Turgut Noyan Research and Training Center | Adana | Turkey | 01250 | |
| 221 | University of Health Sciences,Gulhane School of Medicine | Ankara | Turkey | 06010 | |
| 222 | Hacettepe Universitesi | Ankara | Turkey | 06230 | |
| 223 | Memorial Ankara Hastanesi | Ankara | Turkey | 06520 | |
| 224 | Ankara City Hospital | Ankara | Turkey | 06800 | |
| 225 | Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital | Ankara | Turkey | ||
| 226 | Akdeniz University Medical Faculty | Antalya | Turkey | 07059 | |
| 227 | Dicle Üniversitesi | Diyarbakir | Turkey | 21200 | |
| 228 | Trakya University | Edirne | Turkey | 22030 | |
| 229 | Medipol Mega University Hospital | Istanbul | Turkey | 34214 | |
| 230 | Acıbadem Maslak Hastanesi | İstanbul | Turkey | 34457 | |
| 231 | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Istanbul | Turkey | 34722 | |
| 232 | İnönü Üniversitesi Turgut Özal Tıp Merkezi | Malatya | Turkey | 44280 | |
| 233 | Mersin University | Mersin | Turkey | 33343 | |
| 234 | MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department | Kryvyi Rih | Dnipropetrovska Oblast | Ukraine | 50048 |
| 235 | CNPE "Regional Center of Oncology" | Kharkiv | Kharkivska Oblast | Ukraine | 61070 |
| 236 | Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council | Odesa | Odeska Oblast | Ukraine | 65025 |
| 237 | Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" | Vinnytsia | Vinnytska Oblast | Ukraine | 21029 |
| 238 | Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council | Lutsk | Volynska Oblast | Ukraine | 43018 |
| 239 | Uzhgorod Central City Clinical Hospital | Uzhhorod | Zakarpatska Oblast | Ukraine | 88000 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04975308
Other Study ID Numbers:
- 18175
- J2J-OX-JZLC
- 2021-000079-35
First Posted:
Jul 23, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
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:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: