A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting
Recruiting · NCT07230691 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
60 locations listed.
- MVZ am Klinikum Aschaffenburg Onkologie - Aschaffenburg, Germany
- Ospedale San Giuseppe Moscati di Avellino - Avellino, Italy
- Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II - Bari, Italy
- Royal United Hospital - Bath, United Kingdom
- ASST Papa Giovanni XXIII Bergamo - Bergamo, Italy
- Evangelisches Klinikum Bethel - Bielefeld, Germany
- Augusta Kliniken Bochum Hattingen - Bochum, Germany
- ASST Spedali Civili Brescia - Brescia, Italy
- Fakultni nemocnice Brno - Brno, Czechia
- UZ Brussel - Brussels, Belgium
- Istituto di Candiolo, IRCCS - Candiolo, Italy
- Velindre Hospital - Cardiff, United Kingdom
- PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania - Catania, Italy
- Azienda Ospedaliera Pugliese Ciaccio Catanzaro - Catanzaro, Italy
- Klinikum Chemnitz gGmbH - Chemnitz, Germany
- Haematologie u Onkologie Koeln MV Zentrum - Cologne, Germany
- Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim - Cologne, Germany
- Hosp Reina Sofia - Córdoba, Spain
- Eastbourne District General Hospital - Eastbourne, United Kingdom
- UZ Antwerpen - Edegem, Belgium
- Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung - Essen, Germany
- Universitaetsklinikum Essen - Essen, Germany
- Ospedale Policlinico San Martino IRCCS - Genova, Italy
- University Hospital Graz - Graz, Austria
- Royal Surrey County Hospital NHS Trust - Guildford, United Kingdom
- Facharztzentrum Eppendorf - Hamburg, Germany
- Onkologie am Raschplatz - Hanover, Germany
- Klinikum Region Hannover Klinikum Siloah - Hanover, Germany
- Jessa Ziekenhuis - Hasselt, Belgium
- New Cross Hospital - Heath Town, United Kingdom
- Lungenklinik Hemer - Hemer, Germany
- Fakultni nemocnice Hradec Kralove - Hradec Králové, Czechia
- Hosp. de Jerez de La Frontera - Jerez de la Frontera, Spain
- Klinikum Klagenfurt am Worthersee - Klagenfurt, Austria
- Klinikum Konstanz - Konstanz, Germany
- Az Groeninge - Kortrijk, Belgium
- Chu Helora Hospital La Louviere Site Jolimont - La Louvière, Belgium
- LA Regio Kliniken Klinik Landshut Mitte - Landshut, Germany
- Azienda Ospedaliera ''Vito Fazzi'' - Lecce, Italy
- CHU de Liege - Liège, Belgium
- Royal Marsden Hospital - London, United Kingdom
- Hosp. Univ. Lucus Augusti - Lugo, Spain
- The Christie NHS Foundation Trust Christie Hospital - Manchester, United Kingdom
- San Raffaele Hospital - Milan, Italy
- Istituto Dei Tumori Di Milano - Milan, Italy
- European Institute of Oncology - Milan, Italy
- ASST Grande Ospedale Metropolitano Niguarda - Milan, Italy
- San Gerardo Hospital - Monza, Italy
- Hosp Regional Univ de Malaga - Málaga, Spain
- Fondazione G Pascale Istituto Nazionale Tumori IRCCS - Naples, Italy
- Landeskrankenhaus Hochzirl Natters - Natters, Austria
- MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH - Neuss, Germany
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara - Novara, Italy
- ASL Gallura - Ospedale Giovanni Paolo II - Olbia, Italy
- Fakultni nemocnice Olomouc - Olomouc, Czechia
- Aou San Luigi Gonzaga - Orbassano, Italy
- Complexo Hosp. Univ. de Ourense - Ourense, Spain
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Palermo, Italy
- A.O.R Villa Sofia Cervello - Palermo, Italy
- Hosp. Univ. Son Espases - Palma de Mallorca, Spain
Showing 60 of 80 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →