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

NCT07230691 | Recruiting

• 1 other identifier: 61186372NSC4014
• Study Type: observational
• Target: 380
• Locations: 8 countries
• Sites: 80

Brief 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Real-World Time to Treatment Discontinuation (rwTTD)

  rwTTD is defined as the time from the date of initiation of the amivantamab-containing regimen to discontinuation of the full amivantamab containing regimen for any reason, including disease progression, treatment toxicity or death.

  Up to approximately 60 Months

Secondary Outcomes (10)

• Real-World Progression-Free Survival (rwPFS)

  Up to approximately 60 Months

• Real-World Time to Next Treatment (rwTTNT)

  Up to approximately 60 Months

• Real-World Overall Survival (rwOS)

  Up to approximately 60 Months

• Real-World Time to Subsequent Treatment Discontinuation (rwTTD2)

  Up to approximately 60 Months

• Number of Participants with Adverse Events (AEs) by Severity

  Up to approximately 60 Months

Study Arms (2)

Cohort B: Amivantamab with carboplatin and pemetrexed

Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, who received at least 1 dose of amivantamab in combination with carboplatin and pemetrexed, as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.

Cohort C: Amivantamab and lazertinib

Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (first-line therapy) who received at least 1 dose of amivantamab in combination with lazertinib as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants with advanced NSCLC.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (80)

University Hospital Graz

Graz, 8036, Austria

RECRUITING

Klinikum Klagenfurt am Worthersee

Klagenfurt, 9020, Austria

RECRUITING

Landeskrankenhaus Hochzirl Natters

Natters, 6161, Austria

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Az Groeninge

Kortrijk, 8500, Belgium

RECRUITING

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, 7100, Belgium

RECRUITING

CHU de Liege

Liège, 4000, Belgium

RECRUITING

Vitaz

Sint-Niklaas, 9100, Belgium

RECRUITING

Fakultni nemocnice Brno

Brno, 625 00, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice Olomouc

Olomouc, 77900, Czechia

RECRUITING

Fakultni Thomayerova nemocnice

Prague, 140 59, Czechia

RECRUITING

MVZ am Klinikum Aschaffenburg Onkologie

Aschaffenburg, 63739, Germany

RECRUITING

Evangelisches Klinikum Bethel

Bielefeld, 33611, Germany

RECRUITING

Augusta Kliniken Bochum Hattingen

Bochum, 44791, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

RECRUITING

Haematologie u Onkologie Koeln MV Zentrum

Cologne, 50677, Germany

RECRUITING

Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

Cologne, 51109, Germany

RECRUITING

Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung

Essen, 45136, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Facharztzentrum Eppendorf

Hamburg, 20249, Germany

RECRUITING

Onkologie am Raschplatz

Hanover, 30161, Germany

RECRUITING

Klinikum Region Hannover Klinikum Siloah

Hanover, 30449, Germany

RECRUITING

Lungenklinik Hemer

Hemer, 58675, Germany

RECRUITING

Klinikum Konstanz

Konstanz, 78464, Germany

RECRUITING

LA Regio Kliniken Klinik Landshut Mitte

Landshut, 84034, Germany

RECRUITING

MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH

Neuss, 41462, Germany

RECRUITING

Knappschaft Kliniken MVZ Nord GmbH

Recklinghausen, 45659, Germany

RECRUITING

Hospital Bethanien Solingen

Solingen, 42699, Germany

RECRUITING

MVZ Onkologie Groschek Keller

Stolberg, 52222, Germany

RECRUITING

Bundeswehrkrankenhaus Ulm

Ulm, 89081, Germany

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

Assuta MC

Tel Aviv, 6971028, Israel

RECRUITING

Ospedale San Giuseppe Moscati di Avellino

Avellino, 83100, Italy

RECRUITING

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, 70124, Italy

RECRUITING

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127, Italy

RECRUITING

ASST Spedali Civili Brescia

Brescia, 25123, Italy

RECRUITING

Istituto di Candiolo, IRCCS

Candiolo, 10060, Italy

RECRUITING

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, 95123, Italy

RECRUITING

Azienda Ospedaliera Pugliese Ciaccio Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

RECRUITING

Azienda Ospedaliera ''Vito Fazzi''

Lecce, 73100, Italy

RECRUITING

San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Istituto Dei Tumori Di Milano

Milan, 20133, Italy

RECRUITING

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

San Gerardo Hospital

Monza, 20900, Italy

RECRUITING

Fondazione G Pascale Istituto Nazionale Tumori IRCCS

Naples, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, 28100, Italy

RECRUITING

ASL Gallura - Ospedale Giovanni Paolo II

Olbia, 07026, Italy

RECRUITING

Aou San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

RECRUITING

A.O.R Villa Sofia Cervello

Palermo, 90146, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Di Parma

Parma, 43126, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Campus Bio Medico di Roma

Roma, 128, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena

Rome, 00144, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Sassari

Sassari, 07100, Italy

RECRUITING

Ospedali Riuniti Di Ancona

Torrette-Ancona, 60126, Italy

RECRUITING

Azienda Sanitaria Territoriale Pesaro Urbino

Urbino, 61121, Italy

RECRUITING

Hosp Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

RECRUITING

Hosp. Univ. Lucus Augusti

Lugo, 27003, Spain

RECRUITING

Hosp Regional Univ de Malaga

Málaga, 29011, Spain

RECRUITING

Complexo Hosp. Univ. de Ourense

Ourense, 32005, Spain

RECRUITING

Hosp. Univ. Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Universitario Virgen Rocio

Seville, 41013, Spain

RECRUITING

Hosp. Clinico Univ. de Valladolid

Valladolid, 47003, Spain

RECRUITING

Royal United Hospital

Bath, BA1 3NG, United Kingdom

RECRUITING

Velindre Hospital

Cardiff, CF14 2TL, United Kingdom

RECRUITING

Eastbourne District General Hospital

Eastbourne, BN21 2UD, United Kingdom

RECRUITING

Royal Surrey County Hospital NHS Trust

Guildford, GU2 7XX, United Kingdom

RECRUITING

New Cross Hospital

Heath Town, WV10 0QP, United Kingdom

RECRUITING

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 19, 2030
• Study Completion (Estimated): December 17, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CZ (4); BE (7); IL (3); IT (27); AU (3); ES (9); DE (19); GB (8)