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NCT07230691

A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

380

Start Date

2025-12-03

Completion Date

2030-12-17

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Carcinoma, Non-Small-Cell Lung

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)

Locations (45)

Klinikum Klagenfurt am Worthersee

Klagenfurt, Austria

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Thomayerova nemocnice

Prague, Czechia

MVZ am Klinikum Aschaffenburg Onkologie

Aschaffenburg, Germany

Evangelisches Klinikum Bethel

Bielefeld, Germany

Augusta Kliniken Bochum Hattingen

Bochum, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Haematologie u Onkologie Koeln MV Zentrum

Cologne, Germany

Facharztzentrum Eppendorf

Hamburg, Germany

Onkologie am Raschplatz

Hanover, Germany

Klinikum Region Hannover Klinikum Siloah

Hanover, Germany

Lungenklinik Hemer

Hemer, Germany

Klinikum Konstanz

Konstanz, Germany

MVZ Onkologie Groschek Keller

Stolberg, Germany

Bundeswehrkrankenhaus Ulm

Ulm, Germany

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Assuta MC

Tel Aviv, Israel

Ospedale San Giuseppe Moscati di Avellino

Avellino, Italy

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, Italy

Istituto di Candiolo, IRCCS

Candiolo, Italy

Azienda Ospedaliera Pugliese Ciaccio Catanzaro

Catanzaro, Italy

Azienda Ospedaliera ''Vito Fazzi''

Lecce, Italy

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

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, Italy

ASL Gallura - Ospedale Giovanni Paolo II

Olbia, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

A.O.R Villa Sofia Cervello

Palermo, Italy

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy

Ospedali Riuniti Di Ancona

Torrette-Ancona, Italy

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. Lucus Augusti

Lugo, Spain

Hospital Universitario Virgen Rocio

Seville, Spain

Hosp. Clinico Univ. de Valladolid

Valladolid, Spain

Eastbourne District General Hospital

Eastbourne, United Kingdom

New Cross Hospital

Heath Town, United Kingdom

Royal Marsden Hospital

London, United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom

Clinical Research Directory

A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

Summary

Key Details

Conditions

Eligibility Criteria

Locations (45)