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NCT07230691Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
380 (estimated)
First submitted
14 Nov 2025
Start date
3 Dec 2025
Primary completion date
19 Nov 2030
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT07230691

What you commit to

  • Study type: Observational
  • Planned participants: 380
  • From 3 Dec 2025 to the primary completion date, 19 Nov 2030
  • 90 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (90)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Graz
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GrazAustriaRecruiting
Klinikum Klagenfurt am Worthersee
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KlagenfurtAustriaRecruiting
Landeskrankenhaus Hochzirl Natters
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NattersAustriaRecruiting
UZ Brussel
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BrusselsBelgiumRecruiting
UZ Antwerpen
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EdegemBelgiumRecruiting
JESSA Ziekenhuis
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HasseltBelgiumRecruiting
AZ Groeninge
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KortrijkBelgiumRecruiting
Chu Helora Hospital La Louviere Site Jolimont
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La LouvièreBelgiumRecruiting
CHU de Liège
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LiègeBelgiumRecruiting
Vitaz
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Sint-NiklaasBelgiumRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Fakultni nemocnice Olomouc
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OlomoucCzechiaRecruiting
Fakultni Thomayerova nemocnice
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PragueCzechiaRecruiting
MVZ am Klinikum Aschaffenburg Onkologie
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AschaffenburgGermanyRecruiting
Evangelisches Klinikum Bethel
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BielefeldGermanyRecruiting
Augusta Kliniken Bochum Hattingen
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BochumGermanyRecruiting
Gesundheit Nord - Klinikverbund Bremen
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BremenGermanyRecruiting
Klinikum Chemnitz gGmbH
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ChemnitzGermanyRecruiting
Haematologie u Onkologie Koeln MV Zentrum
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CologneGermanyRecruiting
Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
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CologneGermanyRecruiting
Florence Nightingale Krankenhaus
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DüsseldorfGermanyRecruiting
Universitaetsklinikum - Essen
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EssenGermanyRecruiting
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
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EssenGermanyRecruiting
Facharztzentrum Eppendorf
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HamburgGermanyRecruiting
Onkologie am Raschplatz
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HanoverGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Klinikum Region Hannover Klinikum Siloah
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HanoverGermanyRecruiting
Lungenklinik Hemer
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HemerGermanyRecruiting
Klinikum Konstanz
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KonstanzGermanyRecruiting
LA Regio Kliniken Klinik Landshut Mitte
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LandshutGermanyRecruiting
MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
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NeussGermanyRecruiting
Knappschaft Kliniken MVZ Nord GmbH
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RecklinghausenGermanyRecruiting
Hospital Bethanien Solingen
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SolingenGermanyRecruiting
MVZ Onkologie Groschek Keller
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StolbergGermanyRecruiting
Bundeswehrkrankenhaus Ulm
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UlmGermanyRecruiting
Hosp Univ A Coruna
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A CoruñaSpainRecruiting
Hosp. Univ. de Burgos
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BurgosSpainRecruiting
Hosp Reina Sofia
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CórdobaSpainRecruiting
Hosp. de Jerez de La Frontera
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Jerez de la FronteraSpainRecruiting
Hosp. Univ. Lucus Augusti
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LugoSpainRecruiting
Hosp Regional Univ de Malaga
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MálagaSpainRecruiting
Complexo Hosp. Univ. de Ourense
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OurenseSpainRecruiting
Hosp. Univ. Son Espases
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Palma de MallorcaSpainRecruiting
Hosp. Clinico Univ. de Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Virgen Rocio
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SevilleSpainRecruiting
Hosp. Clinico Univ. de Valladolid
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ValladolidSpainRecruiting
Hosp. Alvaro Cunqueiro
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VigoSpainRecruiting
Royal United Hospital
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BathUnited KingdomRecruiting
Velindre Hospital
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CardiffUnited KingdomRecruiting
Eastbourne District General Hospital
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EastbourneUnited KingdomRecruiting
Royal Surrey County Hospital NHS Trust
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GuildfordUnited KingdomRecruiting
New Cross Hospital
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Heath TownUnited KingdomRecruiting
Royal Marsden Hospital
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust - Christie Hospital
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ManchesterUnited KingdomRecruiting
Royal Marsden Hospital (Sutton)
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SuttonUnited KingdomRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Assuta MC
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Tel AvivIsraelRecruiting
Ospedale San Giuseppe Moscati di Avellino
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AvellinoItalyRecruiting
CRO IRCCS Istituto Nazionale Tumori
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AvianoItalyRecruiting
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
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BariItalyRecruiting
ASST Papa Giovanni XXIII Bergamo
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BergamoItalyRecruiting
ASST Spedali Civili Brescia
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BresciaItalyRecruiting
Istituto di Candiolo, IRCCS
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CandioloItalyRecruiting
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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CataniaItalyRecruiting
Azienda Ospedaliera Pugliese Ciaccio Catanzaro
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CatanzaroItalyRecruiting
Ospedale Policlinico San Martino IRCCS
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GenovaItalyRecruiting
Azienda Ospedaliera ''Vito Fazzi''
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LecceItalyRecruiting
San Raffaele Hospital
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MilanItalyRecruiting
European Institute of Oncology
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MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Istituto Dei Tumori Di Milano
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MilanItalyRecruiting
San Gerardo Hospital
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MonzaItalyRecruiting
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
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NaplesItalyRecruiting
Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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NovaraItalyRecruiting
ASL Gallura - Ospedale Giovanni Paolo II
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OlbiaItalyRecruiting
Aou San Luigi Gonzaga
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OrbassanoItalyRecruiting
A.O.R Villa Sofia Cervello
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PalermoItalyRecruiting
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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PalermoItalyRecruiting
Azienda Ospedaliero Universitaria di Parma
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ParmaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
U.O.C. Ematologia Ospedale S. Maria delle Croci
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RavennaItalyRecruiting
Campus Bio Medico di Roma
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RomaItalyRecruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
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RomaItalyRecruiting
Istituto Nazionale Tumori Regina Elena
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria di Sassari
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SassariItalyRecruiting
Ospedali Riuniti Di Ancona
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Torrette-AnconaItalyRecruiting
Azienda Sanitaria Territoriale Pesaro Urbino
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UrbinoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.