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Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice

Status: Recruiting
Location: See all (44) locations...
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Klinikum Klagenfurt am Worthersee
RECRUITING
Klagenfurt
Germany
MVZ am Klinikum Aschaffenburg Onkologie
RECRUITING
Aschaffenburg
Evangelisches Klinikum Bethel
RECRUITING
Bielefeld
Augusta Kliniken Bochum Hattingen
RECRUITING
Bochum
Klinikum Chemnitz gGmbH
RECRUITING
Chemnitz
Haematologie u Onkologie Koeln MV Zentrum
RECRUITING
Cologne
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
RECRUITING
Essen
Facharztzentrum Eppendorf
RECRUITING
Hamburg
Klinikum Region Hannover Klinikum Siloah
RECRUITING
Hanover
Onkologie am Raschplatz
RECRUITING
Hanover
Lungenklinik Hemer
RECRUITING
Hemer
Klinikum Konstanz
RECRUITING
Konstanz
MVZ Onkologie Groschek Keller
RECRUITING
Stolberg
Bundeswehrkrankenhaus Ulm
RECRUITING
Ulm
Israel
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Assuta MC
RECRUITING
Tel Aviv
Italy
Ospedale San Giuseppe Moscati di Avellino
RECRUITING
Avellino
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
RECRUITING
Bari
Istituto di Candiolo, IRCCS
RECRUITING
Candiolo
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
RECRUITING
Catania
Azienda Ospedaliera Pugliese Ciaccio Catanzaro
RECRUITING
Catanzaro
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
Azienda Ospedaliera ''Vito Fazzi''
RECRUITING
Lecce
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
European Institute of Oncology
RECRUITING
Milan
Istituto Dei Tumori Di Milano
RECRUITING
Milan
San Raffaele Hospital
RECRUITING
Milan
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
RECRUITING
Novara
ASL Gallura - Ospedale Giovanni Paolo II
RECRUITING
Olbia
A.O.R Villa Sofia Cervello
RECRUITING
Palermo
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
Azienda Ospedaliero Universitaria di Sassari
RECRUITING
Sassari
Ospedali Riuniti Di Ancona
RECRUITING
Torrette-ancona
Spain
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp. Univ. Lucus Augusti
RECRUITING
Lugo
Hospital Universitario Virgen Rocio
RECRUITING
Seville
Hosp. Clinico Univ. de Valladolid
RECRUITING
Valladolid
United Kingdom
Eastbourne District General Hospital
RECRUITING
Eastbourne
New Cross Hospital
RECRUITING
Heath Town
Royal Marsden Hospital
RECRUITING
London
The Christie NHS Foundation Trust Christie Hospital
RECRUITING
Manchester
Royal Marsden Hospital (Sutton)
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2030-12-17
Participants
Target number of participants: 380
Treatments
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.
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.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov