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JOURNAL ONKOLOGIE – STUDIE
MARIPOSA

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04487080

Studienbeginn:
September 2020

Letztes Update:
28.05.2021

Wirkstoff:
Amivantamab, Osimertinib, Lazertinib, Placebo

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations
(3 von 296)

Zentralklinik Bad Berka GmbH
99437 Bad Berka
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Helios Klinikum Emil von Behring GmbH
14165 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
70839 Gerlingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
LungenClinic Grosshansdorf GmbH
22927 Grosshandorf
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Thoraxklinik am Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenklinik Hemer
58675 Hemer
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Universitaetsklinikum Koeln
50937 Koeln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Kliniken der Stadt Koeln gGmbH
51109 Koeln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
POIS Leipzig GbR
04357 Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinik Loewenstein gGmbH
74245 Loewenstein
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Pius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Yuma Regional Medical Center
85364 Yuma
United StatesRekrutierend» Google-Maps
Compassionate Cancer Care
92708 Fountain Valley
United StatesZurückgezogen» Google-Maps
Pacific Shores Medical Group in Long Beach
90813 Long Beach
United StatesRekrutierend» Google-Maps
University of California, Irvine
92868 Orange
United StatesNoch nicht rekrutierend» Google-Maps
Ventura County Hematology Oncology Specialists
93030 Oxnard
United StatesZurückgezogen» Google-Maps
Palo Alto Medical Foundation Research Institute
94086 Sunnyvale
United StatesZurückgezogen» Google-Maps
Rocky Mountain Cancer Centers
80124 Lone Tree
United StatesRekrutierend» Google-Maps
Georgetown University Hospital
20007 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Medstar Washington Hospital Center
20010 Washington
United StatesNoch nicht rekrutierend» Google-Maps
University of Florida
32610 Gainesville
United StatesZurückgezogen» Google-Maps
Mayo Clinic
32224 Jacksonville
United StatesNoch nicht rekrutierend» Google-Maps
Cancer Specialists of North Florida
32256 Jacksonville
United StatesRekrutierend» Google-Maps
University Cancer & Blood Center, LLC
30607 Athens
United StatesRekrutierend» Google-Maps
Fort Wayne Medical Oncology and Hematology
46825 Fort Wayne
United StatesZurückgezogen» Google-Maps
Pontchartrain Cancer Center
70433 Covington
United StatesZurückgezogen» Google-Maps
East Jefferson General Hospital
70006 Metairie
United StatesNoch nicht rekrutierend» Google-Maps
Center for Cancer and Blood Disorders
20817 Bethesda
United StatesZurückgezogen» Google-Maps
Barbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesZurückgezogen» Google-Maps
Minnesota Oncology Hematology, P.A.
55435 Edina
United StatesRekrutierend» Google-Maps
Mayo Clinic
55905 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesZurückgezogen» Google-Maps
Essex Oncology of North Jersey
07109 Belleville
United StatesZurückgezogen» Google-Maps
Regional Cancer Care Associates LLC
08816 East Brunswick
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mt. Sinai
10029 New York
United StatesZurückgezogen» Google-Maps
University of Pittsburgh Medical Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Baptist Cancer Center
38133 Bartlett
United StatesZurückgezogen» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesZurückgezogen» Google-Maps
Oncology Consultants - Texas
77030 Houston
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
Instituto Alexander Fleming
C1428ANZ Buenos Aires
ArgentinaRekrutierend» Google-Maps
Hospital Italiano de Buenos Aires
C1181ACF C.a.b.a.
ArgentinaZurückgezogen» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
CP 1125 Capital Federal
ArgentinaRekrutierend» Google-Maps
Hospital Privado Centro Medico de Cordoba
X5016KEH Cordoba
ArgentinaRekrutierend» Google-Maps
Centro Oncologico Riojano Integral (Cori)
F5300COE La Rioja
ArgentinaRekrutierend» Google-Maps
Flinders Medical Centre
5042 Bedford Park
AustraliaRekrutierend» Google-Maps
St John of God Hospital Murdoch
6150 Murdoch
AustraliaZurückgezogen» Google-Maps
St John of God Hospital Murdoch
6150 Murdoch
AustraliaRekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Southern Medical Day Care Centre
2500 Wollongong
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
1200 Brussel
BelgiumRekrutierend» Google-Maps
Grand Hôpital de Charleroi, site Notre Dame
6000 Charleroi
BelgiumRekrutierend» Google-Maps
Fundacao Pio Xii - Hospital De Cancer De Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Hospital Evangélico de Cachoeiro de Itapemirim
29308020 Cachoeiro de Itapemirim
BrazilRekrutierend» Google-Maps
Ynova Pesquisa Clinica
88020-210 Florianopolis
BrazilRekrutierend» Google-Maps
Hospital de Caridade de Ijui
98700-000 Ijuí
BrazilRekrutierend» Google-Maps
Liga Norte Riograndense Contra O Cancer
59062-000 Natal
BrazilRekrutierend» Google-Maps
UPCO Unidade de Pesquisa Clinica em Oncologia
96020 080 Pelotas
BrazilRekrutierend» Google-Maps
Santa Casa de Misericordia de Porto Alegre
90020-090 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro de Pesquisa em Oncologia - PUCRS
90610 000 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
INCA - Instituto Nacional Do Cancer
20231-050 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto D'Or de Pesquisa e Ensino (IDOR)
22281-100 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Ibcc - Instituto Brasileiro de Controle Do Cancer
Sao Paulo
BrazilRekrutierend» Google-Maps
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
18030-075 Sorocaba
BrazilRekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo ICESP
01246-000 São Paulo
BrazilRekrutierend» Google-Maps
Fundação Antônio Prudente - A.C. Camargo Cancer Center
01509-900 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
William Osler Health System
L6R 3J7 Brampton
CanadaNoch nicht rekrutierend» Google-Maps
Juravinski Cancer Centre
L8V 5C2 Hamilton
CanadaNoch nicht rekrutierend» Google-Maps
The Ottawa Hospital Cancer Centre
K1H 8L6 Ottawa
CanadaNoch nicht rekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaZurückgezogen» Google-Maps
McGill University Health Centre
H3G 1A4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Beijing Friendship Hospital, Capital Medical University
100050 Beijing
ChinaRekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Chest hospital, Capital medical university
101199 Beijing
ChinaRekrutierend» Google-Maps
Peking University International Hospital
102206 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Jilin cancer hospital
130000 Changchun
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
The First People's Hospital Of Changzhou
213003 Changzhou
ChinaNoch nicht rekrutierend» Google-Maps
Sichuan Cancer Hospital
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital, Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Southwest Hospital
400038 ChongQing
ChinaNoch nicht rekrutierend» Google-Maps
Third Military Medical University Daping Hospital Cancer Center
400042 Chongqing
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Sun Yat-sen University
510080 Guang Zhou
ChinaRekrutierend» Google-Maps
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
510120 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hang Zhou
ChinaNoch nicht rekrutierend» Google-Maps
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
310006 Hangzhou
ChinaZurückgezogen» Google-Maps
Second Affiliated Hospital, School of Medicine, Zhejiang University
310009 Hangzhou
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Zhejiang University College of Medicine
310009 Hangzhou
ChinaRekrutierend» Google-Maps
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
310016 Hangzhou
ChinaRekrutierend» Google-Maps
Harbin medical university cancer hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Huizhou Municipal Central Hospital
516001 Huizhou
ChinaNoch nicht rekrutierend» Google-Maps
Taizhou Hospital of Zhejiang Province
317000 Linhai
ChinaRekrutierend» Google-Maps
Nantong Tumor Hospital
226300 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Ruijin Hospital, Shanghai Jiao Tong University
200025 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200032 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai Zhongshan Hospital
20030 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai Pulmonary Hospital
200433 Shanghai
ChinaZurückgezogen» Google-Maps
Shanghai East Hospital
310000 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shengjing Hospital of China Medical University
110022 Shenyang
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University General Hospital
300052 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
Cancer Hospital of Xinjiang Medical University
830000 Urumchi
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
ChinaRekrutierend» Google-Maps
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
430030 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Yantai Yuhuangding Hospital
264000 Yantai
ChinaNoch nicht rekrutierend» Google-Maps
Henan Cancer Hospital
450008 Zhengzhou
ChinaNoch nicht rekrutierend» Google-Maps
CHU de Grenoble - Hôpital Albert Michallon
38700 La Tronche
FranceRekrutierend» Google-Maps
Orszagos Koranyi Tbc es Pulmonologiai Intezet
H-1529 Budapest
HungaryRekrutierend» Google-Maps
Veszprém Megyei Tudőgyógyintézet
8582 Farkasgyepü
HungaryRekrutierend» Google-Maps
Mátrai Gyógyintézet-Bronchológia
3233 Gyöngyös
HungaryRekrutierend» Google-Maps
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz
8000 Szekesfehervar
HungaryNoch nicht rekrutierend» Google-Maps
Markusovszky Egyetemi Oktatokorhaz
9700 Szombathely
HungaryNoch nicht rekrutierend» Google-Maps
Tudogyogyintezet Torokbalint
2045 Torokbalint
HungaryRekrutierend» Google-Maps
Basavatarakam Indo-American Hospital
500034 Hyderabad
IndiaRekrutierend» Google-Maps
Tata Memorial Hospital
400012 Mumbai
IndiaNoch nicht rekrutierend» Google-Maps
Rambam Health Corporation
3109601 Haifa
IsraelNoch nicht rekrutierend» Google-Maps
Rabin Medical Center
49100 Petah Tikva
IsraelNoch nicht rekrutierend» Google-Maps
Chaim Sheba Medical Center
5262100 Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
Tel-Aviv Sourasky Medical Center
6423906 Tel-Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Ospedale San Giuseppe Moscati di Avellino
83100 Avellino
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
95123 Catania
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
20122 Milano
ItalyRekrutierend» Google-Maps
IRCCS Ospedale San Raffaele
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Aou San Luigi Gonzaga
10043 Orbassano
ItalyNoch nicht rekrutierend» Google-Maps
Juntendo University Hospital
113-8431 Bunkyo-Ku
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-Ku
JapanRekrutierend» Google-Maps
Kansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-Maps
Kanazawa University Hospital
920-8641 Kanazawa
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osaka-Sayama
JapanRekrutierend» Google-Maps
National Hospital Organization Yamaguchi Ube Medical Center
755-0241 Ube
JapanRekrutierend» Google-Maps
Wakayama Medical University Hospital
641-8510 Wakayama
JapanRekrutierend» Google-Maps
Inje University Haeundae Paik Hospital
48108 Busan
Korea, Republic ofRekrutierend» Google-Maps
Chungbuk National University Hospital
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Hospital
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
8308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Hospital Tengku Ampuan Afzan
25100 Kuantan
MalaysiaRekrutierend» Google-Maps
Beacon International Specialist Centre
46050 Petaling Jaya
MalaysiaRekrutierend» Google-Maps
Mexico Centre for Clinical Research, S.A. de C.V.
03100 Ciudad de Mexico
MexicoNoch nicht rekrutierend» Google-Maps
Health Pharma Professional Research
03840 Ciudad de Mexico
MexicoNoch nicht rekrutierend» Google-Maps
Médica Sur
14050 Ciudad de Mexico
MexicoNoch nicht rekrutierend» Google-Maps
Hospital Civil de Guadalajara Fray Antonio Alcalde
44280 Guadalajara
MexicoNoch nicht rekrutierend» Google-Maps
CIMOVA, Morals Vargas Centro de Investigación SC
37000 Leon
MexicoNoch nicht rekrutierend» Google-Maps
Instituto Nacional de Cancerologia
14080 Mexico
MexicoNoch nicht rekrutierend» Google-Maps
i Can Oncology Center
64710 Monterrey
MexicoNoch nicht rekrutierend» Google-Maps
Oncología Integral Satelite
53100 Naucalpan
MexicoNoch nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsZurückgezogen» Google-Maps
Ziekenhuis St Jansdal
3844 DG Harderwijk
NetherlandsRekrutierend» Google-Maps
Maastricht UMC+
6229 HX Maastricht
NetherlandsNoch nicht rekrutierend» Google-Maps
Jeroen Bosch Ziekenhuis
5223 GZ s-Hertogenbosch
NetherlandsRekrutierend» Google-Maps
Centrum Onkologii im. Prof. F. Lukaszczyka
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-214 Gdańsk
PolandRekrutierend» Google-Maps
Szpitale Pomorskie Sp. z o.o.
81-519 Gdynia
PolandRekrutierend» Google-Maps
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
10-357 Olsztyn
PolandRekrutierend» Google-Maps
Private Specialist Hospitals - MedPolonia
60-693 Poznan
PolandRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
02-781 Warszawa
PolandRekrutierend» Google-Maps
Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente
1769-001 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar Universitario do Porto, EPE
4099-001 Porto
PortugalNoch nicht rekrutierend» Google-Maps
Instituto Portugues de Oncologia
4200-072 Porto
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar de São João, EPE
4200-319 Porto
PortugalNoch nicht rekrutierend» Google-Maps
Pan American Center for Oncology Trials LLC
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Irkutsk Regional Oncology Dispensary
664035 Irkutsk
Russian FederationRekrutierend» Google-Maps
State Medical Institution 'Republican Clinical Oncological Centre' at Republic of Tatarstan
420029 Kazan
Russian FederationZurückgezogen» Google-Maps
Moscow City Oncology Hospital № 62
143423 Krasnogorsk
Russian FederationRekrutierend» Google-Maps
Krasnoyarsk Regional Oncology Dispensary
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Leningrad Regional Oncology Dispensary
188663 Kuzmolovsky
Russian FederationRekrutierend» Google-Maps
Moscow Oncology Research Center n.a. Blokhin
115478 Moscow
Russian FederationZurückgezogen» Google-Maps
Central Clinical Hospital
121359 Moscow
Russian FederationZurückgezogen» Google-Maps
City Clinical Hospital #1
360000 Nalchik
Russian FederationRekrutierend» Google-Maps
Nizhny Novgorod Regional Oncological Dispensary
603000 Nizhniy Novgorod
Russian FederationNoch nicht rekrutierend» Google-Maps
Omsk Clinical Oncology Dispensary
664013 Omsk
Russian FederationRekrutierend» Google-Maps
N.N. Petrov Research Institute Of Oncology
197758 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Oncology Medical Clinics AV Medical group
199034 St-Petersburg
Russian FederationRekrutierend» Google-Maps
City Clinical Oncology Dispensary
198255 St. Petersburg
Russian FederationZurückgezogen» Google-Maps
Tomsk Cancer Research Institute
634050 Tomsk
Russian FederationRekrutierend» Google-Maps
Bashkir State Medical University
450083 Ufa
Russian FederationRekrutierend» Google-Maps
Yaroslavl Regional Clinical Oncology Hospital
150054 Yaroslavl
Russian FederationRekrutierend» Google-Maps
Inst. Cat. D'Oncologia-Badalona
08916 Badalona
SpainRekrutierend» Google-Maps
Hosp. de La Santa Creu I Sant Pau
08025 Barcelona
SpainRekrutierend» Google-Maps
Institut Català D'Oncologia Girona
17007 Girona
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Gral. Univ. Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hosp. Univ. Pta. de Hierro Majadahonda
28222 Majadahonda
SpainRekrutierend» Google-Maps
Hosp. Regional Univ. de Malaga
29010 Málaga
SpainRekrutierend» Google-Maps
Hosp. Clinico Univ. Lozano Blesa
50009 Zaragoza
SpainRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation
833 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taipei Medical University Shuang Ho Hospital
23561 New Taipei
TaiwanRekrutierend» Google-Maps
Chung Shan Medical University Hospital
402 Taichung
TaiwanRekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei City
TaiwanNoch nicht rekrutierend» Google-Maps
Phramongkutklao Hospital and Medical College
10400 Bangkok
ThailandRekrutierend» Google-Maps
Chiangrai Prachanukroh Hospital
57000 Chaing Rai
ThailandSchwebend» Google-Maps
Songklanagarind Hospital, Prince of Songkla University
90110 Songkla
ThailandRekrutierend» Google-Maps
Başkent University Medical Faculty Adana Application and Research Center
01250 Adana
TurkeyNoch nicht rekrutierend» Google-Maps
Gazi University Hospital
6560 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Trakya University Medical Faculty
22030 Edirne
TurkeyRekrutierend» Google-Maps
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
34098 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Medipol Mega University Hospital
34214 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
34722 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Izmir Medical Park Hospital
35580 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Necmettin Erbakan University Meram Medical Faculty
42080 Konya
TurkeyNoch nicht rekrutierend» Google-Maps
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
49102 Dnipro
UkraineNoch nicht rekrutierend» Google-Maps
Municipal non-profit enterprise 'Regional Center of Oncology'
61070 Kharkiv
UkraineRekrutierend» Google-Maps
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
02091 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Municipal Institution 'Odesa Clinical Oncology Dispensary'
65010 Odesa
UkraineNoch nicht rekrutierend» Google-Maps
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
88000 Uzhgorod
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Edinburgh Cancer Centre Western General
EH4 2XU Edinburgh
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UCL Cancer Institute
NW1 2PG London
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Chelsea And Westminster Hospital
Sw10 9nh London
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The Royal Marsden NHS Trust
SW3 6JJ London
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Christie NHS Foundation Trust
M20 4BX Manchester
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Nottingham University Hospitals NHS Trust
NG5 1PB Nottingham
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The Royal Marsden NHS Trust
SM2 5PT Sutton
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Studien-Informationen

Detailed Description:

Worldwide, lung cancer is the most commonly diagnosed cancer. In NSCLC the most prevalent

actionable driver mutations result in the activation of epidermal growth factor receptor

(EGFR). Osimertinib and Lazertinib are EGFR tyrosine kinase inhibitors (TKIs). Amivantamab is

a novel bispecific antibody that targets the extracellular domain of both EGFR and MET and

can inhibit tumor growth driven by EGFR and mesenchymal-epithelial transition (MET)

receptors. Lazertinib inhibits primary activating Exon 19dell and Exon 21 L858R substitution

EGFR mutations, and the EGFR T790M+ resistance mutation. The hypothesis is that the

amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with

single-agent osimertinib (Arm B). The study consists of 3 phases: Screening Phase, Treatment

Phase and Follow-up Phase. Participants will undergo response evaluation criteria in solid

tumors (RECIST 1.1), pharmacokinetics, and safety evaluations (adverse events, laboratory

tests, vital sign measurements, physical examinations).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant must have newly diagnosed histologically or cytologically confirmed,

locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment

naive and not amenable to curative therapy including surgical resection or

chemoradiation

- The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as

detected by an food and drug administration (FDA)-approved or other validated test in

a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the

United states [US]) or an accredited local laboratory (sites outside of the US) in

accordance with site standard of care

- Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow

for central analysis of EGFR mutation status and blood (for circulating tumor

deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and

pharmacogenomic analysis)

- Any toxicities from prior anticancer therapy must have resolved to common terminology

criteria for adverse events (CTCAE) Grade 1 or baseline level

- Participant must have at least 1 measurable lesion, according to response evaluation

criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated.

Measurable lesions should not have been biopsied during screening, but if only 1

non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be

acceptable as a target lesion, provided the baseline tumor assessment scans are

performed at least 14 days after the biopsy

Exclusion Criteria:

- Participant has received any prior systemic treatment for locally advanced or

metastatic disease (adjuvant or neoadjuvant therapy for early stage disease is

allowed, if administered more than 12 months prior to the development of locally

advanced or metastatic disease)

- Participant has an active or past medical history of leptomeningeal disease

- Participant with untreated spinal cord compression. A participant that has been

definitively treated with surgery or radiation and has a stable neurological status

for at least 2 weeks prior to randomization is eligible provided they are off

corticosteroid treatment or receiving low-dose corticosteroid treatment less than or

equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent

- Participant has an active or past medical history of interstitial lung disease

(ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis

- Participant has known allergy, hypersensitivity, or intolerance to the excipients used

in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to

the use of osimertinib

- Participant has symptomatic brain metastases. A participant with asymptomatic or

previously treated and stable brain metastases may participate in this study

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR) (Time Frame - Up to approximately 42 months):
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occured first, based on BICR using response evaluation criteria in solid tumors (RECIST) v1.1.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 60 months (time from the date of randomization until the date of death due to any cause)):
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

2. Objective Response Rate (ORR) (Time Frame - Up to approximately 42 months):
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.

3. Duration of Response (DOR) (Time Frame - Up to approximately 42 months):
DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.

4. Progression-Free Survival After First Subsequent Therapy (PFS2) (Time Frame - Up to approximately 42 months):
The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.

5. Time to Symptomatic Progression (TTSP) (Time Frame - Up to approximately 42 months):
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.

6. Intracranial PFS (Time Frame - Up to approximately 42 months):
Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1.

7. Incidence and Severity of Adverse Events (AEs) (Time Frame - Up to approximately 60 months):
Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.

8. Number of Participants with Clinical Laboratory Abnormalities (Time Frame - Up to approximately 60 months):
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.

9. Number of Participants with Vital Signs Abnormalities (Time Frame - Up to approximately 60 months):
Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.

10. Number of Participants with Physical Examination Abnormalities (Time Frame - Up to approximately 60 months):
Number of participants with physical examination abnormalities will be reported.

11. Serum Concentration of Amivantamab (Time Frame - Up to approximately 42 months):
Serum samples will be analyzed to determine concentrations of amivantamab.

12. Plasma Concentration of Lazertinib (Time Frame - Up to approximately 42 months):
Plasma samples will be analyzed to determine concentrations of lazertinib.

13. Number of Participants with Anti-Amivantamab Antibodies (Time Frame - Up to approximately 42 months):
Number of participants with antibodies to amivantamab will be reported.

14. Change from Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ) (Time Frame - Baseline Up to approximately 42 months):
The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit.

15. Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (Time Frame - Baseline Up to approximately 42 months):
EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Studien-Arme

  • Experimental: Treatment Arm A (Open-label): Amivantamab and Lazertinib
    Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80*3) orally once daily.
  • Active Comparator: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
    Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80*3) orally once daily.
  • Experimental: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
    Participants will receive lazertinib 240 mg (80*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

Geprüfte Regime

  • Amivantamab (JNJ-61186372):
    Participants will receive amivantamab intravenously.
  • Osimertinib:
    Participants will receive osimertinib capsules orally.
  • Lazertinib (JNJ-73841937 and YH-25448):
    Participants will receive lazertinib tablets orally.
  • Placebo:
    Participants will receive matching placebo orally.

Quelle: ClinicalTrials.gov


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