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JOURNAL ONKOLOGIE – STUDIE
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

Rekrutierend

NCT-Nummer:
NCT06119581

Studienbeginn:
Dezember 2023

Letztes Update:
06.05.2024

Wirkstoff:
LY3537982, Pembrolizumab, Placebo, Cisplatin, Carboplatin, Pemetrexed

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Eli Lilly and Company

Collaborator:
Loxo Oncology, Inc.

Studienleiter

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)
Study Director
Eli Lilly and Company

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com» Kontaktdaten anzeigen

Studienlocations
(3 von 365)

Onkologiezentrum Donauwörth
86609 Donauwörth
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Darmkrebszentrum am Krankenhaus Martha-Maria Halle-Dölau
Röntgenstraße 1
6120 Halle (Saale)
DeutschlandRekrutierend» Google-Maps
LungenClinic Grosshansdorf
22927 Grosshansdorf
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
Evangelische Lungenklinik Berlin
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Helios Klinikum Emil von Behring Berlin-Zehlendorf
14165 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Clearview Cancer Institute
35805 Huntsville
United StatesRekrutierend» Google-Maps
The University of Arizona Cancer Center - North Campus
85719 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
Mercy UC Davis Cancer Center
95340 Merced
United StatesRekrutierend» Google-Maps
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
90502 Torrance
United StatesRekrutierend» Google-Maps
Yale University School of Medicine
06510 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
Sibley Memorial Hospital
20016 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Miami Cancer Institute at Baptist Health, Inc.
33176 Miami
United StatesRekrutierend» Google-Maps
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
34474 Ocala
United StatesRekrutierend» Google-Maps
Comprehensive Hematology Oncology
33709 Saint Petersburg
United StatesRekrutierend» Google-Maps
University of Illinois at Chicago
60612 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
University of Chicago Hospital
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Springfield Clinic Main Campus
62702 Springfield
United StatesRekrutierend» Google-Maps
Indiana University Melvin and Bren Simon Cancer Center
46202 Indianapolis
United StatesNoch nicht rekrutierend» Google-Maps
Community Cancer Center North
46250 Indianapolis
United StatesRekrutierend» Google-Maps
The University of Kansas Cancer Center - Westwood
66205 Westwood
United StatesNoch nicht rekrutierend» Google-Maps
University of Kentucky Chandler Medical Center
40536 Lexington
United StatesNoch nicht rekrutierend» Google-Maps
Johns Hopkins Bayview Medical Center
21224 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Lahey Hospital & Medical Center
01805 Burlington
United StatesRekrutierend» Google-Maps
University of Michigan
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-Maps
Cancer and Hematology Centers of Western Michigan
49503 Grand Rapids
United StatesRekrutierend» Google-Maps
Allina Health Cancer Institute
55407 Minneapolis
United StatesRekrutierend» Google-Maps
HealthPartners Cancer Research Center
55101 Saint Paul
United StatesRekrutierend» Google-Maps
Saint Louis University Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Dartmouth-Hitchcock Medical Center
03756 Lebanon
United StatesNoch nicht rekrutierend» Google-Maps
Capital Health Medical Center - Hopewell
08534 Pennington
United StatesRekrutierend» Google-Maps
University of New Mexico Comprehensive Cancer Center
87131 Albuquerque
United StatesNoch nicht rekrutierend» Google-Maps
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
11501 Mineola
United StatesRekrutierend» Google-Maps
Laura and Isaac Perlmutter Cancer Center
10016 New York
United StatesRekrutierend» Google-Maps
Manhattan Eye, Ear and Throat Hospital
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Clinical Research Alliance
11590 Westbury
United StatesRekrutierend» Google-Maps
University of North Carolina Medical Center
27599 Chapel Hill
United StatesNoch nicht rekrutierend» Google-Maps
UNC REX Cancer Center
27607 Raleigh
United StatesNoch nicht rekrutierend» Google-Maps
University of Oklahoma Health Sciences Center, Peggy and Charles Stephenson Oklahoma Cancer Center
73104 Oklahoma City
United StatesNoch nicht rekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
Providence St. Vincent Medical Center
97225 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Kaiser Permanente Interstate Medical Office Central
97227 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Bryn Mawr Hospital
19010 Bryn Mawr
United StatesNoch nicht rekrutierend» Google-Maps
Paoli Memorial Hospital
19301 Paoli
United StatesNoch nicht rekrutierend» Google-Maps
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
19107 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
UPMC Hillman Cancer Center
15232 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
Lankenau Medical Center
19096 Wynnewood
United StatesNoch nicht rekrutierend» Google-Maps
Medical University of South Carolina
29425 Charleston
United StatesNoch nicht rekrutierend» Google-Maps
Tidelands Health Oncology
29576 Murrells Inlet
United StatesNoch nicht rekrutierend» Google-Maps
Baptist Memorial Hospital-Memphis
38120 Memphis
United StatesRekrutierend» Google-Maps
William Beaumont Army Medical Center
79918 Fort Bliss
United StatesRekrutierend» Google-Maps
Brooke Army Medical Center
78234 Fort Sam Houston
United StatesRekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Swedish Medical Center
98104 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Icon Cancer Centre Wesley
4066 Auchenflower
AustraliaRekrutierend» Google-Maps
Sunshine Coast University Hospital
4575 Birtinya
AustraliaRekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Perth
AustraliaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaRekrutierend» Google-Maps
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
5530 Yvoir
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:

Phone: 081423351» Ansprechpartner anzeigen
AZ Sint-Jan Brugge-Oostende AV
8000 Brugge
BelgiumRekrutierend» Google-Maps
Clinica Amo - Rio Vermelho
41950-640 Salvador
BrazilNoch nicht rekrutierend» Google-Maps
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
70200-730 Brasilia
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Brasilia
71635580 Lago sul
BrazilNoch nicht rekrutierend» Google-Maps
Hospital São Domingos
65060-645 Bequimao
BrazilNoch nicht rekrutierend» Google-Maps
Oncominas
37554-216 Pouso Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Universitário Evangélico Mackenzie
80730-150 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Liga Norte Riograndense Contra o Câncer
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Tacchini
95700-084 Bento Gonçalves
BrazilNoch nicht rekrutierend» Google-Maps
Hospital São Lucas da PUCRS
90610-000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Paulistano
01321-001 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Instituto D'Or de Pesquisa e Ensino (IDOR)
04543-000 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
COE Ensino e Pesquisa
12242-660 São José dos Campos
BrazilNoch nicht rekrutierend» Google-Maps
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
22250-905 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Icesp - Instituto Do Câncer Do Estado de São Paulo
01246-000 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Sírio Libanês
01308-060 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Centro Paulista de Oncologia Clínica
01452-000 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Instituto de Assist├ncia M├dica ao Servidor P
04039-901 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
BC Cancer Vancouver
V5Z 4E6 Vancouver
CanadaNoch nicht rekrutierend» Google-Maps
CIUSSS- saguenay-Lac-Saint-Jean
G7H 5H6 Chicoutimi
CanadaNoch nicht rekrutierend» Google-Maps
Unité de Recherche Clinique du CISSS des Laurentides
J7Z 2V4 Saint-Jérôme
CanadaNoch nicht rekrutierend» Google-Maps
Wannan Medical College Yijishan Hospital
241001 Wuhu
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of the Third Military Medical University
400038 Shapingba
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Provincial Cancer Hospital
350014 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Guangzhou Medical University
510120 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Affiliated Hospital of Guangdong Medical University
524004 Zhanjiang
ChinaNoch nicht rekrutierend» Google-Maps
Liuzhou People's Hospital
545006 Liuzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xinxiang Medical University
453100 Xinxiang
ChinaNoch nicht rekrutierend» Google-Maps
Wuhan Union Hospital
430022 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Tongji Hospital Tongji Medical,Science & Technology
430030 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Renmin Hospital of Wuhan University
430060 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Xiangyang Central Hospital
441021 Xiangyang
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
ZhuZhou Central Hospital
412007 Zhuzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First People's Hospital of Changzhou
213003 Changzhou
ChinaNoch nicht rekrutierend» Google-Maps
Nanjing First Hospital
210012 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Jiangsu Province Hospital
210029 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Nantong Tumor Hospital
226361 Nantong
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University
330006 Nanchang
ChinaNoch nicht rekrutierend» Google-Maps
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
710038 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
Jinan Central Hospital
250013 Jinan
ChinaNoch nicht rekrutierend» Google-Maps
Shandong Cancer Hospital
250117 Jinan
ChinaNoch nicht rekrutierend» Google-Maps
LinYi Cancer Hospital
276001 Linyi
ChinaNoch nicht rekrutierend» Google-Maps
The Third People's Hospital of Chengdu (CDTPH)
610031 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 ChengDu
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University Cancer Institute and Hospital
300060 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xinjiang Medical University
830054 Urumchi
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University
310003 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Taizhou Hospital of Zhejiang Province
317099 Linhai
ChinaNoch nicht rekrutierend» Google-Maps
Hwa Mei Hospital University of Chinese Academy of Sciences
315099 Ningbo
ChinaNoch nicht rekrutierend» Google-Maps
Sichuan Cancer hospital
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Yichang Central People's Hospital
443003 Yichang
ChinaNoch nicht rekrutierend» Google-Maps
Nemocnice AGEL Ostrava - Vitkovice a.s.
703 84 Ostrava
CzechiaRekrutierend» Google-Maps
Roskilde University Hospital
4000 Roskilde
DenmarkNoch nicht rekrutierend» Google-Maps
Centre Antoine-Lacassagne
06189 Nice
FranceNoch nicht rekrutierend» Google-Maps
Nouvel Hôpital Civil (NHC)
67091 Strasbourg
FranceNoch nicht rekrutierend» Google-Maps
CHU Bordeaux Haut-Leveque
33600 Pessac
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
35033 Rennes
FranceNoch nicht rekrutierend» Google-Maps
Institut de Cancérologie de l'Ouest
44805 Saint Herblain
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Robert Schuman
57070 Vantoux
FranceNoch nicht rekrutierend» Google-Maps
Institut Jean Godinot
51726 Reims
FranceNoch nicht rekrutierend» Google-Maps
CHU Lille - Institut Coeur Poumon
59037 Lille Cedex
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
83100 Toulon
FranceNoch nicht rekrutierend» Google-Maps
Hospices Civils de Lyon - Hopital Louis Pradel
69677 Bron
FranceNoch nicht rekrutierend» Google-Maps
Sainte Catherine Institut du Cancer Avignon Provence
84918 Avignon
FranceNoch nicht rekrutierend» Google-Maps
Agios Savvas Regional Cancer Hospital
115 22 Athens
GreeceNoch nicht rekrutierend» Google-Maps
Errikos Dunant Hospital Center
115 26 Athens
GreeceNoch nicht rekrutierend» Google-Maps
European Interbalkan Medical Center
570 01 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Bacs-Kiskun Varmegyei Oktatokorhaz
6000 Kecskemét
HungaryRekrutierend» Google-Maps
Országos Korányi Pulmonológiai Intézet
1121 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Farkasgyepui Tudogyogyintezet
8582 Farkasgyepű
HungaryRekrutierend» Google-Maps
Országos Onkológiai Intézet
1122 Budapest
HungaryRekrutierend» Google-Maps
Regional Cancer Centre - Thiruvananthapuram
695011 Thiruvananthapuram
IndiaNoch nicht rekrutierend» Google-Maps
Krishna Institute of Medical Sciences - Karad
415539 Karad
IndiaNoch nicht rekrutierend» Google-Maps
Kolhapur Cancer Centre Private Limited
416234 Kolhāpur
IndiaNoch nicht rekrutierend» Google-Maps
Sahyadri Super Speciality Hospital
411004 Pune
IndiaNoch nicht rekrutierend» Google-Maps
All India Institute of Medical Sciences
751019 Bhubaneswar
IndiaNoch nicht rekrutierend» Google-Maps
Ashwin Hospital
641012 Coimbatore
IndiaNoch nicht rekrutierend» Google-Maps
Tata Memorial Centre - Homi Bhabha Cancer Hospital
221002 Varanasi
IndiaNoch nicht rekrutierend» Google-Maps
Banaras Hindu University
221005 Varanasi
IndiaNoch nicht rekrutierend» Google-Maps
Tata Medical Center
700160 Kolkata
IndiaNoch nicht rekrutierend» Google-Maps
Jawaharlal Institute Of Postgraduate Medical Education And Research
605006 Puducherry
IndiaNoch nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale di Circolo e Fondazione Macchi Varese
21100 Varese
ItalyRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama
JapanRekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Sapporo
JapanRekrutierend» Google-Maps
Kanagawa Cardiovascular and Respiratory Center
236-0051 Yokohama
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata-shi
JapanRekrutierend» Google-Maps
Kansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-Maps
Kindai University Hospital- Osakasayama Campus
589-8511 Osakasayama
JapanNoch nicht rekrutierend» Google-Maps
National Hospital Organization Kinki-chuo Chest Medical Center
591-8555 Sakai
JapanRekrutierend» Google-Maps
Tominaga Hospital
411-8777 Nagaizumi-cho,Sunto-gun
JapanRekrutierend» Google-Maps
Tokyo Metropolitan Komagome Hospital
113-8677 Bunkyō-Ku
JapanNoch nicht rekrutierend» Google-Maps
Japanese Foundation for Cancer Research
135-8550 Koto
JapanRekrutierend» Google-Maps
National Hospital Organization Yamaguchi Ube Medical Center
755-0241 Ube
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Kyushu University Hospital
812-8582 Fukuoka
JapanNoch nicht rekrutierend» Google-Maps
University Hospital,Kyoto Prefectural University of Medicine
602-8566 Kyoto
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Wakayama Medical University Hospital
641-8510 Wakayama
JapanNoch nicht rekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University Of Korea St. Vincent's Hospital
16247 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
KS011 Yangsan
Korea, Republic ofRekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Gangnam-gu
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Yeouido St. Mary's Hospital
07345 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Keimyung University Dongsan Hospital
42601 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Centro Onco-Hematológico Roma (COHR)
06700 Mexico City
MexicoNoch nicht rekrutierend» Google-Maps
Higiea Oncologia
11819 Mexico City
MexicoNoch nicht rekrutierend» Google-Maps
PanAmerican Clinical Research - Guadalajara
44670 Guadalajara
MexicoNoch nicht rekrutierend» Google-Maps
Actualidad Basada en la Investigación del Cáncer
44680 Guadalajara
MexicoNoch nicht rekrutierend» Google-Maps
Renati Innovation
44680 Guadalajara
MexicoNoch nicht rekrutierend» Google-Maps
Dr. Jose Eleuterio Gonzalez
64460 Monterrey
MexicoNoch nicht rekrutierend» Google-Maps
Oncare - Unidad Valle
66220 San Pedro Garza García
MexicoNoch nicht rekrutierend» Google-Maps
Health Pharma Querétaro
76230 Juriquilla
MexicoNoch nicht rekrutierend» Google-Maps
Clinica Integral Internacional de Oncología
72530 Puebla
MexicoNoch nicht rekrutierend» Google-Maps
Jeroen Bosch ziekenhuis
5223 GZ Den Bosch
NetherlandsNoch nicht rekrutierend» Google-Maps
Erasmus Medisch Centrum
3015 GD Rotterdam
NetherlandsRekrutierend» Google-Maps
Akershus Universitetssykehus
1478 Lørenskog
NorwayNoch nicht rekrutierend» Google-Maps
Drammen Sykehus, Vestre Viken HF
3004 Drammen
NorwayNoch nicht rekrutierend» Google-Maps
Haukeland Universitetssjukehus
5021 Bergen
NorwayNoch nicht rekrutierend» Google-Maps
Sykehuset Innlandet HF Gjøvik
2819 Gjøvik
NorwayNoch nicht rekrutierend» Google-Maps
Stavanger Universitetssykehus
4011 Stavanger
NorwayNoch nicht rekrutierend» Google-Maps
St. Olavs Hospital
7030 Trondheim
NorwayNoch nicht rekrutierend» Google-Maps
Oslo Universitetssykehus Ullevål
0450 Oslo
NorwayNoch nicht rekrutierend» Google-Maps
Champalimaud Foundation
1400-038 Lisbon
PortugalNoch nicht rekrutierend» Google-Maps
Hospital Pulido Valente
1769-001 Lisbon
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar E Universitário De Coimbra
3040 Coimbra
PortugalNoch nicht rekrutierend» Google-Maps
Hospital da Luz Lisboa
1500-650 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Hospital CUF Porto
4100-180 Porto
PortugalNoch nicht rekrutierend» Google-Maps
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
4200-072 Porto
PortugalNoch nicht rekrutierend» Google-Maps
Ovidius Clinical Hospital OCH
905900 Ovidiu
RomaniaRekrutierend» Google-Maps
CHUAC-Hospital Teresa Herrera
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Universitari Son Espases
07120 Palma De Mallorca
SpainRekrutierend» Google-Maps
Complejo Asistencial Universitario de León - Hospital de León
24071 León
SpainRekrutierend» Google-Maps
Hospital Universitari Dexeusa
08028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Jerez de la Frontera
11407 Jerez De La Frontera
SpainRekrutierend» Google-Maps
Complejo Hospitalario de Navarra
31009 Pamplona
SpainRekrutierend» Google-Maps
Västmanlands Sjukhus Västerås
721 89 Västerås
SwedenNoch nicht rekrutierend» Google-Maps
CHUV (centre hospitalier universitaire vaudois)
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Kantonsspital Winterthur
8401 Winterthur
SwitzerlandNoch nicht rekrutierend» Google-Maps
UniversitätsSpital Zürich
8091 Zürich
SwitzerlandNoch nicht rekrutierend» Google-Maps
Hualien Tzu Chi Medical Center
970 Hualien City
TaiwanNoch nicht rekrutierend» Google-Maps
Chi Mei Hospital - Liouying Branch
73657 Tainan City
TaiwanRekrutierend» Google-Maps
National Taiwan University Cancer Center (NTUCC)
106 Taipei City
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
640 Douliu City
TaiwanRekrutierend» Google-Maps
Buddhist Dalin Tzu Chi General Hospital
622 Chiayi
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Hospital
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
407 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation-Linkou Branch
333 Taoyuan
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Adana Medical Park Seyhan Hastanesi
01140 Adana
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Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
06200 Ankara
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Ankara City Hospital
06800 Ankara
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Bezmialem Vakf Üniversitesi
34093 Istanbul
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İ.A.Ü VM Medical Park Florya Hastanesi
34295 Istanbul
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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
34722 Istanbul
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Aberdeen Royal Infirmary
AB25 2ZN Aberdeen
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DD1 9SY Dundee
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S10 2SJ Sheffield
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Cheltenham General Hospital
GL53 7AN Cheltenham
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Mount Vernon Hospital
HA6 2RN Northwood
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The Christie NHS Foundation Trust
M20 4 BX Manchester
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St James's University Hospital
LS9 7TF Leeds
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Alle anzeigen

Studien-Informationen

Detailed Description:

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

arm, non-randomized.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) (Time Frame - 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

2. Part A and Part B: Progression-Free Survival (PFS) (Time Frame - 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:

1. Part A and Part B: Overall Survival (OS) (Time Frame - Randomization to date of death from any cause. (Estimated as up to 3 years)):
Part A and Part B: OS

2. 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) (Time Frame - Randomization to disease progression or death. (Estimated as approximately 1 year)):
ORR per RECIST v1.1 by BICR

3. Part A and Part B: Duration of Response (DOR) (Time Frame - 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

4. Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) (Time Frame - Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)):
DCR per RECIST v1.1 by BICR

5. Part A and Part B: Time to Response (TTR) (Time Frame - 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

6. Part A and Part B: PFS2 (Time Frame - 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

7. Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) (Time Frame - 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.

8. 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 (Time Frame - 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.

9. 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) (Time Frame - 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.

10. 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 (Time Frame - 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.

Studien-Arme

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"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"

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