Een onderzoek naar klinische uitkomsten bij deelnemers met EGFR-gemuteerd gevorderd niet-kleincellig longcarcinoom (NSCLC) in een real-world setting (LEPIDOPTERA)
Prospectieve, multinationele, observationele studie van klinische uitkomsten bij EGFR-gemuteerde, gevorderde niet-kleincellige longkanker (NSCLC) patiënten behandeld met goedgekeurde amivantamab-bevattende regimes onder standaard klinische praktijk
The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Study Contact
- Telefoonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studie Locaties
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Brussels, België, 1090
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- UZ Brussel
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Edegem, België, 2650
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- UZ Antwerpen
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Hasselt, België, 3500
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- Jessa Ziekenhuis
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Kortrijk, België, 8500
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- Az Groeninge
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La Louvière, België, 7100
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- Chu Helora Hospital La Louviere Site Jolimont
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Liège, België, 4000
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- CHU de Liege
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Sint-Niklaas, België, 9100
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- Vitaz
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Aschaffenburg, Duitsland, 63739
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- MVZ am Klinikum Aschaffenburg Onkologie
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Bielefeld, Duitsland, 33611
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- Evangelisches Klinikum Bethel
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Bochum, Duitsland, 44791
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- Augusta Kliniken Bochum Hattingen
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Bremen, Duitsland, 28325
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- Gesundheit Nord - Klinikverbund Bremen
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Chemnitz, Duitsland, 09113
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- Klinikum Chemnitz gGmbH
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Cologne, Duitsland, 50677
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- Haematologie u Onkologie Koeln MV Zentrum
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Cologne, Duitsland, 51109
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- Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
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Düsseldorf, Duitsland, 40489
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- Florence Nightingale Krankenhaus
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Essen, Duitsland, 45147
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- Universitaetsklinikum Essen
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Essen, Duitsland, 45136
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- Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
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Hamburg, Duitsland, 20249
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- Facharztzentrum Eppendorf
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Hanover, Duitsland, 30625
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- Medizinische Hochschule Hannover
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Hanover, Duitsland, 30161
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- Onkologie am Raschplatz
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Hanover, Duitsland, 30449
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- Klinikum Region Hannover Klinikum Siloah
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Hemer, Duitsland, 58675
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- Lungenklinik Hemer
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Konstanz, Duitsland, 78464
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- Klinikum Konstanz
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Landshut, Duitsland, 84034
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- LA Regio Kliniken Klinik Landshut Mitte
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Neuss, Duitsland, 41462
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- MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
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Recklinghausen, Duitsland, 45659
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- Knappschaft Kliniken MVZ Nord GmbH
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Solingen, Duitsland, 42699
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- Hospital Bethanien Solingen
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Stolberg, Duitsland, 52222
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- MVZ Onkologie Groschek Keller
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Ulm, Duitsland, 89081
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- Bundeswehrkrankenhaus Ulm
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Petah Tikva, Israël, 4941492
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- Rabin Medical Center
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Ramat Gan, Israël, 5262000
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- Sheba Medical Center
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Tel Aviv, Israël, 6971028
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- Assuta MC
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Avellino, Italië, 83100
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- Ospedale San Giuseppe Moscati di Avellino
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Aviano, Italië, 33081
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- CRO IRCCS Istituto Nazionale Tumori
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Bari, Italië, 70124
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- Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
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Bergamo, Italië, 24127
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- ASST Papa Giovanni XXIII Bergamo
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Brescia, Italië, 25123
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- ASST Spedali Civili Brescia
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Candiolo, Italië, 10060
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- Istituto di Candiolo, IRCCS
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Catania, Italië, 95123
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- PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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Catanzaro, Italië, 88100
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- Azienda Ospedaliera Pugliese Ciaccio Catanzaro
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Genova, Italië, 16132
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- Ospedale Policlinico San Martino IRCCS
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Lecce, Italië, 73100
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- Azienda Ospedaliera ''Vito Fazzi''
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Milan, Italië, 20162
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- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Italië, 20132
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- San Raffaele Hospital
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Milan, Italië, 20133
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- Istituto Dei Tumori Di Milano
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Milan, Italië, 20141
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- European Institute of Oncology
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Monza, Italië, 20900
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- San Gerardo Hospital
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Naples, Italië, 80131
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- Fondazione G Pascale Istituto Nazionale Tumori IRCCS
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Naples, Italië, 80131
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- Universita degli Studi della Campania Luigi Vanvitelli
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Novara, Italië, 28100
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- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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Olbia, Italië, 07026
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- ASL Gallura - Ospedale Giovanni Paolo II
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Orbassano, Italië, 10043
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- Aou San Luigi Gonzaga
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Palermo, Italië, 90127
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- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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Palermo, Italië, 90146
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- A.O.R Villa Sofia Cervello
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Parma, Italië, 43126
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- Azienda Ospedaliero-Universitaria Di Parma
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Pisa, Italië, 56124
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- Azienda Ospedaliero Universitaria Pisana
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Ravenna, Italië, 48121
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- U.O.C. Ematologia Ospedale S. Maria delle Croci
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Roma, Italië, 00168
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- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italië, 128
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- Campus Bio Medico di Roma
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Rome, Italië, 00144
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- Istituto Nazionale Tumori Regina Elena
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Sassari, Italië, 07100
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- Azienda Ospedaliero Universitaria di Sassari
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Torrette-Ancona, Italië, 60126
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- Ospedali Riuniti Di Ancona
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Urbino, Italië, 61121
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- Azienda Sanitaria Territoriale Pesaro Urbino
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Graz, Oostenrijk, 8036
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- University Hospital Graz
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Klagenfurt, Oostenrijk, 9020
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- Klinikum Klagenfurt am Worthersee
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Natters, Oostenrijk, 6161
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- Landeskrankenhaus Hochzirl Natters
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A Coruña, Spanje, 15006
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- Hosp Univ A Coruna
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Burgos, Spanje, 09006
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- Hosp. Univ. de Burgos
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Córdoba, Spanje, 14004
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- Hosp Reina Sofia
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Jerez de la Frontera, Spanje, 11407
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- Hosp. de Jerez de La Frontera
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Lugo, Spanje, 27003
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- Hosp. Univ. Lucus Augusti
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Málaga, Spanje, 29011
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- Hosp Regional Univ de Malaga
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Ourense, Spanje, 32005
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- Complexo Hosp. Univ. de Ourense
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Palma de Mallorca, Spanje, 07120
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- Hosp. Univ. Son Espases
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Santiago de Compostela, Spanje, 15706
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- Hosp. Clinico Univ. de Santiago
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Seville, Spanje, 41013
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- Hospital Universitario Virgen Rocio
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Valladolid, Spanje, 47003
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- Hosp. Clinico Univ. de Valladolid
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Vigo, Spanje, 36312
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- Hosp. Alvaro Cunqueiro
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Brno, Tsjechië, 625 00
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- Fakultni nemocnice Brno
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Hradec Králové, Tsjechië, 500 05
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- Fakultni nemocnice Hradec Kralove
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Olomouc, Tsjechië, 77900
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- Fakultni nemocnice Olomouc
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Prague, Tsjechië, 140 59
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- Fakultni Thomayerova nemocnice
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Bath, Verenigd Koninkrijk, BA1 3NG
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- Royal United Hospital
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Cardiff, Verenigd Koninkrijk, CF14 2TL
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- Velindre Hospital
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Eastbourne, Verenigd Koninkrijk, BN21 2UD
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- Eastbourne District General Hospital
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Guildford, Verenigd Koninkrijk, GU2 7XX
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- Royal Surrey County Hospital NHS Trust
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Heath Town, Verenigd Koninkrijk, WV10 0QP
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- New Cross Hospital
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London, Verenigd Koninkrijk, SW3 6JJ
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- Royal Marsden Hospital
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Manchester, Verenigd Koninkrijk, M20 4BX
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- The Christie NHS Foundation Trust Christie Hospital
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Sutton, Verenigd Koninkrijk, SM2 5PT
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- Royal Marsden Hospital (Sutton)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
The study population will include participants with advanced NSCLC.
Beschrijving
Inclusion Criteria:
- Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab
- Participants or their legally acceptable representative, where applicable, must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements
- Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection
- Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study
Exclusion criteria:
- At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results
- Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use
- Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent
- Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib/ platinum/ pemetrexed)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
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Cohort B: Amivantamab with carboplatin and pemetrexed
Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, who received at least 1 dose of amivantamab in combination with carboplatin and pemetrexed, as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. |
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Cohort C: Amivantamab and lazertinib
Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (first-line therapy) who received at least 1 dose of amivantamab in combination with lazertinib as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Real-World Time to Treatment Discontinuation (rwTTD)
Tijdsspanne: Up to approximately 60 Months
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rwTTD is defined as the time from the date of initiation of the amivantamab-containing regimen to discontinuation of the full amivantamab containing regimen for any reason, including disease progression, treatment toxicity or death. |
Up to approximately 60 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Real-World Progression-Free Survival (rwPFS)
Tijdsspanne: Up to approximately 60 Months
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rwPFS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of investigator-determined disease progression (radiological or clinical) or death due to any cause, whichever occurs first. |
Up to approximately 60 Months
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Real-World Time to Next Treatment (rwTTNT)
Tijdsspanne: Up to approximately 60 Months
|
rwTTNT is defined as the time from initiation of the amivantamab-containing regimen to start of a subsequent systemic treatment following discontinuation of the full amivantamab-containing regimen or death, whichever occurs first. |
Up to approximately 60 Months
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Real-World Overall Survival (rwOS)
Tijdsspanne: Up to approximately 60 Months
|
rwOS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of death from any cause or reason. |
Up to approximately 60 Months
|
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Real-World Time to Subsequent Treatment Discontinuation (rwTTD2)
Tijdsspanne: Up to approximately 60 Months
|
rwTTD2 is defined as the time from initiation of the amivantamab-containing regimen to the discontinuation of the first subsequent therapy for any reason, including disease progression, treatment toxicity or death. |
Up to approximately 60 Months
|
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Number of Participants with Adverse Events (AEs) by Severity
Tijdsspanne: Up to approximately 60 Months
|
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Up to approximately 60 Months
|
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Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy
Tijdsspanne: Up to approximately 60 Months
|
Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported. |
Up to approximately 60 Months
|
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Number of Participants Using Concomitant Medications
Tijdsspanne: Up to approximately 60 Months
|
Participants using concomitant medications including those to manage specific AEs related to the amivantamab-containing regimen, namely infusion related reactions (IRRs), venous thromboembolism (VTEs), and dermatologic AEs including paronychia, will be reported. |
Up to approximately 60 Months
|
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Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score
Tijdsspanne: Up to approximately 60 Months
|
The SKINDEX-16 measures how a participant's skin condition impacts their health-related quality of life. There are 16 questions on a 7-point scale, ranging from 0 (never bothered) to 6 (always bothered). The questionnaire is divided into 3 domains: symptoms (items 1 to 4), emotions (items 5 to 11), and functionality (items 12 to 16). An overall score is the average of the 3 domain scores. All domain scores will be linearly transformed to be in the range from 0 to 100. A score of 0 indicates that the skin condition has no impact on QoL, while a score of 100 indicates the worst possible impact. |
Up to approximately 60 Months
|
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Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Items-30 Scale Score
Tijdsspanne: Up to approximately 60 Months
|
The EORTC QLQ-C30 is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
Up to approximately 60 Months
|
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Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen
Tijdsspanne: Up to approximately 60 Months
|
Three questions regarding reactive and prophylactic management of AEs related to the amivantamab-containing regimen will be reported. These questions cover the type of prophylactic/reactive concomitant medication recommended by the treating physician, frequency of use, and the degree of impact on daily life due to use of the respective medication. |
Up to approximately 60 Months
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 61186372NSC4014
- 61186372NSC4014 (Andere identificatie: Janssen Research & Development, LLC)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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