A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting
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
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 380
- Started
- 3 December 2025
- Main results due
- 19 November 2030
- Study sites
- 86
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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)
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(86)
University Hospital Graz
Graz, Austria
Recruiting
Klinikum Klagenfurt am Worthersee
Klagenfurt, Austria
Recruiting
Landeskrankenhaus Hochzirl Natters
Natters, Austria
Recruiting
UZ Brussel
Brussels, Belgium
Recruiting
UZ Antwerpen
Edegem, Belgium
Recruiting
Jessa Ziekenhuis
Hasselt, Belgium
Recruiting
Az Groeninge
Kortrijk, Belgium
Recruiting
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, Belgium
Recruiting
CHU de Liege
Liège, Belgium
Recruiting
Vitaz
Sint-Niklaas, Belgium
Recruiting
Fakultni nemocnice Brno
Brno, Czechia
Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Recruiting
Fakultni nemocnice Olomouc
Olomouc, Czechia
Recruiting
Fakultni Thomayerova nemocnice
Prague, Czechia
Recruiting
MVZ am Klinikum Aschaffenburg Onkologie
Aschaffenburg, Germany
Recruiting
Evangelisches Klinikum Bethel
Bielefeld, Germany
Recruiting
Augusta Kliniken Bochum Hattingen
Bochum, Germany
Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Recruiting
Haematologie u Onkologie Koeln MV Zentrum
Cologne, Germany
Recruiting
Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
Cologne, Germany
Recruiting
Florence Nightingale Krankenhaus
Düsseldorf, Germany
Recruiting
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
Essen, Germany
Recruiting
Universitaetsklinikum Essen
Essen, Germany
Recruiting
Facharztzentrum Eppendorf
Hamburg, Germany
Recruiting
Onkologie am Raschplatz
Hanover, Germany
Recruiting
Klinikum Region Hannover Klinikum Siloah
Hanover, Germany
Recruiting
Medizinische Hochschule Hannover
Hanover, Germany
Recruiting
Lungenklinik Hemer
Hemer, Germany
Recruiting
Klinikum Konstanz
Konstanz, Germany
Recruiting
LA Regio Kliniken Klinik Landshut Mitte
Landshut, Germany
Recruiting
MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
Neuss, Germany
Recruiting
Knappschaft Kliniken MVZ Nord GmbH
Recklinghausen, Germany
Recruiting
Hospital Bethanien Solingen
Solingen, Germany
Recruiting
MVZ Onkologie Groschek Keller
Stolberg, Germany
Recruiting
Bundeswehrkrankenhaus Ulm
Ulm, Germany
Recruiting
Rabin Medical Center
Petah Tikva, Israel
Recruiting
Sheba Medical Center
Ramat Gan, Israel
Recruiting
Assuta MC
Tel Aviv, Israel
Recruiting
Ospedale San Giuseppe Moscati di Avellino
Avellino, Italy
Recruiting
CRO IRCCS Istituto Nazionale Tumori
Aviano, Italy
Recruiting
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari, Italy
Recruiting
ASST Papa Giovanni XXIII Bergamo
Bergamo, Italy
Recruiting
ASST Spedali Civili Brescia
Brescia, Italy
Recruiting
Istituto di Candiolo, IRCCS
Candiolo, Italy
Recruiting
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, Italy
Recruiting
Azienda Ospedaliera Pugliese Ciaccio Catanzaro
Catanzaro, Italy
Recruiting
Ospedale Policlinico San Martino IRCCS
Genova, Italy
Recruiting
Azienda Ospedaliera ''Vito Fazzi''
Lecce, Italy
Recruiting
San Raffaele Hospital
Milan, Italy
Recruiting
Istituto Dei Tumori Di Milano
Milan, Italy
Recruiting
European Institute of Oncology
Milan, Italy
Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Recruiting
San Gerardo Hospital
Monza, Italy
Recruiting
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy
Recruiting
Universita degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
Novara, Italy
Recruiting
ASL Gallura - Ospedale Giovanni Paolo II
Olbia, Italy
Recruiting
Aou San Luigi Gonzaga
Orbassano, Italy
Recruiting
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Recruiting
A.O.R Villa Sofia Cervello
Palermo, Italy
Recruiting
Showing 60 of 86 sites — filter to narrow it down. 86 of the 86 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07230691. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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