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Lung cancer drug amivantamab under Real-World microscope

NCT ID NCT07230691

Knowledge-focused Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study is observing 380 people with a common type of advanced lung cancer caused by EGFR mutations who are receiving amivantamab as part of their routine care. Researchers will track how long patients stay on treatment and how well it controls the cancer in everyday medical practice. The goal is to understand real-world outcomes, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amivantamab
What this could lead to
If successful, this study could provide real-world evidence on how well amivantamab works for advanced EGFR-mutated lung cancer outside of clinical trials.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and real-world variability. It does not test a new treatment or guarantee improved outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include participants with advanced NSCLC.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    85 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.R Villa Sofia Cervello

    RECRUITING

    Palermo, 90146, Italy

  • ASL Gallura - Ospedale Giovanni Paolo II

    RECRUITING

    Olbia, 07026, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Papa Giovanni XXIII Bergamo

    RECRUITING

    Bergamo, 24127, Italy

  • ASST Spedali Civili Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Aou San Luigi Gonzaga

    RECRUITING

    Orbassano, 10043, Italy

  • Assuta MC

    RECRUITING

    Tel Aviv, 6971028, Israel

  • Augusta Kliniken Bochum Hattingen

    RECRUITING

    Bochum, 44791, Germany

  • Az Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • Azienda Ospedaliera ''Vito Fazzi''

    RECRUITING

    Lecce, 73100, Italy

  • Azienda Ospedaliera Pugliese Ciaccio Catanzaro

    RECRUITING

    Catanzaro, 88100, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    RECRUITING

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliero Universitaria di Sassari

    RECRUITING

    Sassari, 07100, Italy

  • Azienda Ospedaliero-Universitaria Di Parma

    RECRUITING

    Parma, 43126, Italy

  • Azienda Sanitaria Territoriale Pesaro Urbino

    RECRUITING

    Urbino, 61121, Italy

  • Bundeswehrkrankenhaus Ulm

    RECRUITING

    Ulm, 89081, Germany

  • CHU de Liege

    RECRUITING

    Liège, 4000, Belgium

  • CRO IRCCS Istituto Nazionale Tumori

    RECRUITING

    Aviano, 33081, Italy

  • Campus Bio Medico di Roma

    RECRUITING

    Roma, 128, Italy

  • Chu Helora Hospital La Louviere Site Jolimont

    RECRUITING

    La Louvière, 7100, Belgium

  • Complexo Hosp. Univ. de Ourense

    RECRUITING

    Ourense, 32005, Spain

  • Eastbourne District General Hospital

    RECRUITING

    Eastbourne, BN21 2UD, United Kingdom

  • European Institute of Oncology

    RECRUITING

    Milan, 20141, Italy

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, 33611, Germany

  • Facharztzentrum Eppendorf

    RECRUITING

    Hamburg, 20249, Germany

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 140 59, Czechia

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Olomouc

    RECRUITING

    Olomouc, 77900, Czechia

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    RECRUITING

    Naples, 80131, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Haematologie u Onkologie Koeln MV Zentrum

    RECRUITING

    Cologne, 50677, Germany

  • Hosp Regional Univ de Malaga

    RECRUITING

    Málaga, 29011, Spain

  • Hosp Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hosp. Clinico Univ. de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hosp. Clinico Univ. de Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hosp. Univ. Lucus Augusti

    RECRUITING

    Lugo, 27003, Spain

  • Hosp. Univ. Son Espases

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Hosp. de Jerez de La Frontera

    RECRUITING

    Jerez de la Frontera, 11407, Spain

  • Hospital Bethanien Solingen

    RECRUITING

    Solingen, 42699, Germany

  • Hospital Universitario Virgen Rocio

    RECRUITING

    Seville, 41013, Spain

  • Istituto Dei Tumori Di Milano

    RECRUITING

    Milan, 20133, Italy

  • Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Rome, 00144, Italy

  • Istituto di Candiolo, IRCCS

    RECRUITING

    Candiolo, 10060, Italy

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung

    RECRUITING

    Essen, 45136, Germany

  • Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

    RECRUITING

    Cologne, 51109, Germany

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, 09113, Germany

  • Klinikum Klagenfurt am Worthersee

    RECRUITING

    Klagenfurt, 9020, Austria

  • Klinikum Konstanz

    RECRUITING

    Konstanz, 78464, Germany

  • Klinikum Region Hannover Klinikum Siloah

    RECRUITING

    Hanover, 30449, Germany

  • Knappschaft Kliniken MVZ Nord GmbH

    RECRUITING

    Recklinghausen, 45659, Germany

  • LA Regio Kliniken Klinik Landshut Mitte

    RECRUITING

    Landshut, 84034, Germany

  • Landeskrankenhaus Hochzirl Natters

    RECRUITING

    Natters, 6161, Austria

  • Lungenklinik Hemer

    RECRUITING

    Hemer, 58675, Germany

  • MVZ Onkologie Groschek Keller

    RECRUITING

    Stolberg, 52222, Germany

  • MVZ am Klinikum Aschaffenburg Onkologie

    RECRUITING

    Aschaffenburg, 63739, Germany

  • MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH

    RECRUITING

    Neuss, 41462, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • New Cross Hospital

    RECRUITING

    Heath Town, WV10 0QP, United Kingdom

  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

    RECRUITING

    Bari, 70124, Italy

  • Onkologie am Raschplatz

    RECRUITING

    Hanover, 30161, Germany

  • Ospedale Policlinico San Martino IRCCS

    RECRUITING

    Genova, 16132, Italy

  • Ospedale San Giuseppe Moscati di Avellino

    RECRUITING

    Avellino, 83100, Italy

  • Ospedali Riuniti Di Ancona

    RECRUITING

    Torrette-Ancona, 60126, Italy

  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

    RECRUITING

    Catania, 95123, Italy

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital (Sutton)

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Surrey County Hospital NHS Trust

    RECRUITING

    Guildford, GU2 7XX, United Kingdom

  • Royal United Hospital

    RECRUITING

    Bath, BA1 3NG, United Kingdom

  • San Gerardo Hospital

    RECRUITING

    Monza, 20900, Italy

  • San Raffaele Hospital

    RECRUITING

    Milan, 20132, Italy

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262000, Israel

  • The Christie NHS Foundation Trust Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • U.O.C. Ematologia Ospedale S. Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • UZ Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universita degli Studi della Campania Luigi Vanvitelli

    RECRUITING

    Naples, 80131, Italy

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • University Hospital Graz

    RECRUITING

    Graz, 8036, Austria

  • Velindre Hospital

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Vitaz

    RECRUITING

    Sint-Niklaas, 9100, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.