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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
PAPILLON

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

Rekrutierend

NCT-Nummer:
NCT04538664

Studienbeginn:
Oktober 2020

Letztes Update:
30.04.2021

Wirkstoff:
Amivantamab, Pemetrexed, Carboplatin

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 259)

Zentralklinik Bad Berka GmbH
99437 Bad Berka
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Evangelische Lungenklinik Berlin
13125 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenklinik Hemer
58675 Hemer
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» 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
Klinik Loewenstein gGmbH
74245 Loewenstein
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Bethanien Krankenhaus
47441 Moers
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Pius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Oncologianova GmbH
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
City of Hope
91010 Duarte
United StatesNoch nicht rekrutierend» Google-Maps
Compassionate Cancer Care
92708 Fountain Valley
United StatesZurückgezogen» Google-Maps
UC San Diego Moores Cancer Center
92093 La Jolla
United StatesZurückgezogen» Google-Maps
Pacific Shores Medical Group in Long Beach
90813 Long Beach
United StatesNoch nicht rekrutierend» Google-Maps
University of California, Irvine
92868 Orange
United StatesNoch nicht rekrutierend» Google-Maps
University of Colorado
80045 Aurora
United StatesZurückgezogen» Google-Maps
Georgetown University Hospital
20007 Washington
United StatesNoch nicht rekrutierend» Google-Maps
Mayo Clinic
32224 Jacksonville
United StatesNoch nicht rekrutierend» Google-Maps
H. Lee Moffitt Cancer & Research Institute
33612 Tampa
United StatesNoch nicht rekrutierend» 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 StatesZurückgezogen» 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
Mayo Clinic
55905 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Washington University Medical Center
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
Langone Health at NYC University, NYU School of Medicine
10016 New York
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mt. Sinai
10029 New York
United StatesZurückgezogen» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesZurückgezogen» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Sanford Health
57117 Sioux Falls
United StatesNoch nicht rekrutierend» Google-Maps
Vanderbilt University Medical Center
37232 Nashville
United StatesZurückgezogen» Google-Maps
UT Southwestern Medical Center
75390 Dallas
United StatesZurückgezogen» Google-Maps
Utah Cancer Specialists
84106 Salt Lake City
United StatesRekrutierend» Google-Maps
Huntsman Cancer Institute
84112 Salt Lake City
United StatesZurückgezogen» Google-Maps
Virginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Fundacao Pio Xii - Hospital De Cancer De Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Cetus Oncologia
30110-017 Belo Horizonte
BrazilNoch nicht rekrutierend» 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
BrazilNoch nicht rekrutierend» 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
BrazilNoch nicht rekrutierend» Google-Maps
Fundação Antônio Prudente - A.C. Camargo Cancer Center
01509-900 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
The Ottawa Hospital Cancer Centre
K1H 8L6 Ottawa
CanadaNoch nicht rekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
University Health Network
M5G 2C4 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
McGill University Health Centre
H3G 1A4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Chest hospital, Capital medical university
101199 Beijing
ChinaNoch nicht rekrutierend» 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
West China Hospital, Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Medical University Union Hospital
350001 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Sun Yat-sen University
510080 Guang Zhou
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hang Zhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University College of Medicine
310003 Hangzhou
ChinaNoch nicht rekrutierend» 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
ChinaNoch nicht rekrutierend» Google-Maps
Harbin medical university cancer hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Taizhou Hospital of Zhejiang Province
317000 Linhai
ChinaRekrutierend» Google-Maps
Nanjing Drum Tower Hospital
210031 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200032 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai Zhongshan Hospital
200032 ShangHai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai East Hospital
310000 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shengjing Hospital of China Medical University
110004 Shenyang
ChinaNoch nicht rekrutierend» Google-Maps
Cancer Hospital Chinese Academy of Medical Sciences
518116 Shenzhen
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University General Hospital
300052 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
Weifang People's Hospital
261000 Weifang
ChinaNoch nicht rekrutierend» Google-Maps
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
430030 Wuhan
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University
710061 Xi'an
ChinaNoch nicht rekrutierend» Google-Maps
Yantai Yuhuangding Hospital
264000 Yantai
ChinaNoch nicht rekrutierend» Google-Maps
Henan Cancer Hospital
450008 Zhengzhou
ChinaNoch nicht rekrutierend» Google-Maps
Centre Georges François Leclerc
21000 Dijon
FranceRekrutierend» Google-Maps
Centre Hospitalier Le Mans
72037 le mans Cedex 9
FranceRekrutierend» Google-Maps
Orszagos Koranyi Tbc es Pulmonologiai Intezet
H-1529 Budapest
HungaryRekrutierend» Google-Maps
Veszprém Megyei Tudőgyógyintézet
8582 Farkasgyepü
HungaryNoch nicht rekrutierend» 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
HungaryNoch nicht rekrutierend» Google-Maps
Basavatarakam Indo-American Hospital
500034 Hyderabad
IndiaRekrutierend» Google-Maps
Tata Memorial Hospital
400012 Mumbai
IndiaNoch nicht rekrutierend» Google-Maps
Shaare Zedek Medical Center
91031 Jerusalem
IsraelRekrutierend» Google-Maps
Rabin Medical Center
49100 Petah Tikva
IsraelNoch nicht rekrutierend» Google-Maps
Tel-Aviv Sourasky Medical Center
6423906 Tel-Aviv
IsraelRekrutierend» Google-Maps
A.O.U Sant'Orsola-Malpighi
40138 Bologna
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
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
20122 Milano
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Ospedale San Raffaele
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale S. Maria Delle Croci
48121 Ravenna
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas
20089 Rozzano
ItalyNoch nicht rekrutierend» Google-Maps
Juntendo University Hospital
113-8431 Bunkyo-Ku
JapanRekrutierend» Google-Maps
Osaka Habikino Medical Center
583-8588 Habikino
JapanZurückgezogen» Google-Maps
Saitama Medical University International Medical Center
350-1298 Hidaka
JapanRekrutierend» Google-Maps
National Hospital Organization Himeji Medical Center
670-8520 Himeji
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
Kishiwada City Hospital
596-8501 Kishiwada
JapanNoch nicht rekrutierend» Google-Maps
Kobe City Medical Center General Hospital
650-0047 Kobe
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Koto-Ku
JapanRekrutierend» Google-Maps
Kurashiki Central Hospital
710-8602 Kurashiki
JapanRekrutierend» Google-Maps
Matsusaka Municipal Hospital
515-8544 Matsusaka
JapanRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya-Shi
JapanRekrutierend» Google-Maps
National Hospital Organization Nagoya Medical Center
460-0001 Nagoya
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osaka-Sayama
JapanRekrutierend» Google-Maps
Kitasato University Hospital
252-0375 Sagamihara
JapanRekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Sapporo
JapanRekrutierend» Google-Maps
Iwate Medical University Hospital
028-3695 Shiwa-gun
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
GyeongSang National University Hospital
52727 Jinju
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Hospital
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital
03722 Seoul
Korea, Republic ofNoch nicht rekrutierend» 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
University Malaya Medical Centre
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Centro Oncológico de Chihuahua
31217 Chihuahua
MexicoNoch nicht rekrutierend» 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
Instituto Nacional de Cancerologia
14080 Ciudad de Mexico
MexicoNoch nicht rekrutierend» Google-Maps
Hospital Civil de Guadalajara Fray Antonio Alcalde
44280 Guadalajara
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
Centrum Onkologii im. Prof. F. Lukaszczyka
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-214 Gdansk
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 e Universitário de Coimbra, EPE
3045 - 081 Coimbra
PortugalNoch nicht rekrutierend» Google-Maps
Hospital Cuf Descobertas
1998-018 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Hospital Santo Antonio dos Capuchos
G1R 2J6 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 Vila Nova de Gaia/Espinho, E.P.E.
4434-502 Vila Nova de Gaia
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 FederationNoch nicht rekrutierend» Google-Maps
Moscow City Oncology Hospital № 62
143423 Krasnogorsk
Russian FederationRekrutierend» Google-Maps
Krasnoyarsk Regional Oncology Dispensary
660133 Krasnoyarsk
Russian FederationNoch nicht rekrutierend» 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
City Clinical Hospital #1
360000 Nalchik
Russian FederationRekrutierend» Google-Maps
Nizhny Novgorod Regional Oncological Dispensary
603000 Nizhniy Novgorod
Russian FederationRekrutierend» Google-Maps
Leningrad Regional Clinical Hospital
194291 Saint Petersburg
Russian FederationNoch nicht rekrutierend» 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 FederationNoch nicht rekrutierend» Google-Maps
Inst. Cat. D'Oncologia-Badalona
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Hosp. de La Santa Creu I Sant Pau
08025 Barcelona
SpainRekrutierend» Google-Maps
Hosp. Gral. Univ. Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hosp. Univ. Pta. de Hierro Majadahonda
28222 Majadahonda
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
TaiwanNoch nicht rekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei City
TaiwanNoch nicht rekrutierend» Google-Maps
Phramongkutklao Hospital and Medical College
10400 Bangkok
ThailandNoch nicht rekrutierend» Google-Maps
Siriraj Hospital
10700 Bangkok
ThailandNoch nicht rekrutierend» Google-Maps
Songklanagarind Hospital, Prince of Songkla University
90110 Songkla
ThailandNoch nicht rekrutierend» 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
Ankara Bilkent City Hospital
6800 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Trakya University Medical Faculty
22030 Edirne
TurkeyNoch nicht rekrutierend» 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
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
34722 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Izmir Medical Park Hospital
35580 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
49102 Dnipro
UkraineNoch nicht rekrutierend» Google-Maps
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
02091 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
National Cancer Institute
03022 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Municipal Institution 'Odesa Clinical Oncology Dispensary'
65010 Odesa
UkraineZurückgezogen» Google-Maps
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
88000 Uzhgorod
UkraineZurückgezogen» Google-Maps
Edinburgh Cancer Centre Western General
EH4 2XU Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
The Royal Marsden NHS Trust
SW3 6JJ London
United KingdomNoch nicht rekrutierend» Google-Maps
Nottingham University Hospitals NHS Trust
NG5 1PB Nottingham
United KingdomNoch nicht rekrutierend» Google-Maps
The Royal Marsden NHS Trust
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Lung cancer is one of the most common types of cancer and is the most common cause of death

from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung

cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1

(IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and

mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for

the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination

with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with

carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by

EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a

Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last

dose]) and a Follow up phase (from the end of treatment visit and until the end of study,

death, loss to follow-up, or withdrawal of consent from participation in the study, whichever

comes first). An independent data monitoring committee (IDMC) will be commissioned for the

periodic review of safety and tolerability data, as well as planned efficacy analyses.

Efficacy assessments will include disease assessment, symptomatic progression and

patient-reported outcome. Safety assessments will include physical examinations, vital signs,

electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and

clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and

urinalysis). The total duration of the study is up to 48 months.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant must have histologically or cytologically confirmed, locally advanced or

metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary

epidermal growth factor receptor (EGFR) Exon 20ins activating mutation

- Participant must have measurable disease according to Response Evaluation Criteria in

Solid Tumors (RECIST) v1.1.

- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0

or 1

- Participant must agree to genetic characterization of tumor status through the

required pretreatment tumor biopsy (or submission of equivalent archival material), as

well as baseline and periodic blood samples for analysis of tumor mutations in the

bloodstream

- A female participant of childbearing potential must have a negative serum or urine

test at screening and within 72 hours of the first dose of study treatment and must

agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

- Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR

Exon 20ins

- Participant has untreated brain metastases (a participant with definitively, locally

treated metastases who is clinically stable, asymptomatic, and off corticosteroid

treatment for at least 2 weeks prior to randomization is eligible)

- Participant has history of spinal cord compression that has not been treated

definitively with surgery or radiation

- Participant has a medical history of interstitial lung disease (ILD), including

drug-induced ILD, or radiation pneumonitis

- Participant has a contraindication to the use of carboplatin or pemetrexed (refer to

local prescribing information for each agent). Participant has a history of

hypersensitivity to, or cannot take, vitamin B12 or folic acid

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR) (Time Frame - Up to 18 months):
PFS is defined as the time from randomization until the date of objective disease progression based on blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - Up to 48 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.

2. Duration of Response (DoR) (Time Frame - Up to 48 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.

3. Overall Survival (OS) (Time Frame - Up to 48 months):
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

4. Time to Subsequent Therapy (TST) (Time Frame - Up to 48 months):
TST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death.

5. Progression-Free Survival After First Subsequent Therapy (PFS2) (Time Frame - Up to 48 months):
PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS or death after starting the next line of treatment.

6. Time to Symptomatic Progression (TTSP) (Time Frame - Up to 48 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.

7. Incidence and Severity of Adverse Events (AEs) (Time Frame - Up to 48 months):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

8. Number of Participants with Clinical Laboratory Abnormalities (Time Frame - Up to 48 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 48 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 48 months):
Number of participants with physical examination abnormalities will be reported.

11. Serum Concentration of Amivantamab (Time Frame - Up to 48 months):
Serum samples will be analyzed to determine concentrations of amivantamab.

12. Number of Participants with Anti-Amivantamab Antibodies (Time Frame - Up to 48 months):
Number of participants with antibodies to amivantamab will be reported.

13. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (Time Frame - Up to 48 months):
The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

14. Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) (Time Frame - Up to 48 months):
PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.

Studien-Arme

  • Experimental: Arm A: Amivantamab + Chemotherapy
    Participants will receive pemetrexed 500 milligram per meter square (mg/m^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3.
  • Experimental: Arm B: Chemotherapy Alone
    Participants will receive pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles.

Geprüfte Regime

  • Amivantamab (JNJ-61186372):
    Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3.
  • Pemetrexed:
    Pemetrexed will be administration as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arms A and B.
  • Carboplatin:
    Carboplatin will be administration as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.

Quelle: ClinicalTrials.gov


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