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Carcinoma, Non-Small-Cell LungLEPIDOPTERANCT07230691

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

An observational study of Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 90 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
How many people
380 participants
Where
90 sitesin 8 countries
Study dates
3 Dec 2025to 17 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include participants with advanced NSCLC.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

90 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

90 sites in 8 countries

Italy31 sites, 31 recruiting

  • Ospedale San Giuseppe Moscati di Avellino

    Avellino, 83100

    Recruiting

  • CRO IRCCS Istituto Nazionale Tumori

    Aviano, 33081

    Recruiting

  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Recruiting

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, 25123

    Recruiting

  • Istituto di Candiolo, IRCCS

    Candiolo, 10060

    Recruiting

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

    Catania, 95123

    Recruiting

  • Azienda Ospedaliera Pugliese Ciaccio Catanzaro

    Catanzaro, 88100

    Recruiting

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

    Recruiting

  • Azienda Ospedaliera ''Vito Fazzi''

    Lecce, 73100

    Recruiting

  • San Raffaele Hospital

    Milan, 20132

    Recruiting

  • Istituto Dei Tumori Di Milano

    Milan, 20133

    Recruiting

  • European Institute of Oncology

    Milan, 20141

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • San Gerardo Hospital

    Monza, 20900

    Recruiting

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80131

    Recruiting

  • Universita degli Studi della Campania Luigi Vanvitelli

    Naples, 80131

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    Novara, 28100

    Recruiting

  • ASL Gallura - Ospedale Giovanni Paolo II

    Olbia, 07026

    Recruiting

  • Aou San Luigi Gonzaga

    Orbassano, 10043

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

    Recruiting

  • A.O.R Villa Sofia Cervello

    Palermo, 90146

    Recruiting

  • Azienda Ospedaliero-Universitaria Di Parma

    Parma, 43126

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

    Recruiting

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

    Ravenna, 48121

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Campus Bio Medico di Roma

    Roma, 128

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144

    Recruiting

  • Azienda Ospedaliero Universitaria di Sassari

    Sassari, 07100

    Recruiting

  • Ospedali Riuniti Di Ancona

    Torrette-Ancona, 60126

    Recruiting

  • Azienda Sanitaria Territoriale Pesaro Urbino

    Urbino, 61121

    Recruiting

Other trials in Italy

Germany22 sites, 22 recruiting

  • MVZ am Klinikum Aschaffenburg Onkologie

    Aschaffenburg, 63739

    Recruiting

  • Evangelisches Klinikum Bethel

    Bielefeld, 33611

    Recruiting

  • Augusta Kliniken Bochum Hattingen

    Bochum, 44791

    Recruiting

  • Gesundheit Nord - Klinikverbund Bremen

    Bremen, 28325

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

    Recruiting

  • Haematologie u Onkologie Koeln MV Zentrum

    Cologne, 50677

    Recruiting

  • Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

    Cologne, 51109

    Recruiting

  • Florence Nightingale Krankenhaus

    Düsseldorf, 40489

    Recruiting

  • Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung

    Essen, 45136

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Facharztzentrum Eppendorf

    Hamburg, 20249

    Recruiting

  • Onkologie am Raschplatz

    Hanover, 30161

    Recruiting

  • Klinikum Region Hannover Klinikum Siloah

    Hanover, 30449

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Lungenklinik Hemer

    Hemer, 58675

    Recruiting

  • Klinikum Konstanz

    Konstanz, 78464

    Recruiting

  • LA Regio Kliniken Klinik Landshut Mitte

    Landshut, 84034

    Recruiting

  • MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH

    Neuss, 41462

    Recruiting

  • Knappschaft Kliniken MVZ Nord GmbH

    Recklinghausen, 45659

    Recruiting

  • Hospital Bethanien Solingen

    Solingen, 42699

    Recruiting

  • MVZ Onkologie Groschek Keller

    Stolberg, 52222

    Recruiting

  • Bundeswehrkrankenhaus Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

Spain12 sites, 12 recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006

    Recruiting

  • Hosp. Univ. de Burgos

    Burgos, 09006

    Recruiting

  • Hosp Reina Sofia

    Córdoba, 14004

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

    Recruiting

  • Hosp Regional Univ de Malaga

    Málaga, 29011

    Recruiting

  • Complexo Hosp. Univ. de Ourense

    Ourense, 32005

    Recruiting

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hospital Universitario Virgen Rocio

    Seville, 41013

    Recruiting

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003

    Recruiting

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312

    Recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

  • Royal United Hospital

    Bath, BA1 3NG

    Recruiting

  • Velindre Hospital

    Cardiff, CF14 2TL

    Recruiting

  • Eastbourne District General Hospital

    Eastbourne, BN21 2UD

    Recruiting

  • Royal Surrey County Hospital NHS Trust

    Guildford, GU2 7XX

    Recruiting

  • New Cross Hospital

    Heath Town, WV10 0QP

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

    Recruiting

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Belgium7 sites, 7 recruiting

  • UZ Brussel

    Brussels, 1090

    Recruiting

  • UZ Antwerpen

    Edegem, 2650

    Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500

    Recruiting

  • Az Groeninge

    Kortrijk, 8500

    Recruiting

  • Chu Helora Hospital La Louviere Site Jolimont

    La Louvière, 7100

    Recruiting

  • CHU de Liege

    Liège, 4000

    Recruiting

  • Vitaz

    Sint-Niklaas, 9100

    Recruiting

Other trials in Belgium

Czechia4 sites, 4 recruiting

  • Fakultni nemocnice Brno

    Brno, 625 00

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 77900

    Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

    Recruiting

Other trials in Czechia

Austria3 sites, 3 recruiting

  • University Hospital Graz

    Graz, 8036

    Recruiting

  • Klinikum Klagenfurt am Worthersee

    Klagenfurt, 9020

    Recruiting

  • Landeskrankenhaus Hochzirl Natters

    Natters, 6161

    Recruiting

Other trials in Austria

Israel3 sites, 3 recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262000

    Recruiting

  • Assuta MC

    Tel Aviv, 6971028

    Recruiting

Other trials in Israel

About this study

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

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).

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07230691
Study groupRoleWhat they receive
Cohort B: Amivantamab with carboplatin and pemetrexedParticipants 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 lazertinibParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 60 Months

Secondary outcomes (10)

  1. Real-World Progression-Free Survival (rwPFS)

    rwPFS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of investigator-determined disease progression (radiological or clinical) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 60 Months

  2. Real-World Time to Next Treatment (rwTTNT)

    rwTTNT is defined as the time from initiation of the amivantamab-containing regimen to start of a subsequent systemic treatment following discontinuation of the full amivantamab-containing regimen or death, whichever occurs first.

    Measured: Up to approximately 60 Months

  3. Real-World Overall Survival (rwOS)

    rwOS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of death from any cause or reason.

    Measured: Up to approximately 60 Months

  4. Real-World Time to Subsequent Treatment Discontinuation (rwTTD2)

    rwTTD2 is defined as the time from initiation of the amivantamab-containing regimen to the discontinuation of the first subsequent therapy for any reason, including disease progression, treatment toxicity or death.

    Measured: Up to approximately 60 Months

  5. Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to approximately 60 Months

  6. Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy

    Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported.

    Measured: Up to approximately 60 Months

  7. Number of Participants Using Concomitant Medications

    Participants using concomitant medications including those to manage specific AEs related to the amivantamab-containing regimen, namely infusion related reactions (IRRs), venous thromboembolism (VTEs), and dermatologic AEs including paronychia, will be reported.

    Measured: Up to approximately 60 Months

  8. Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score

    The SKINDEX-16 measures how a participant's skin condition impacts their health-related quality of life. There are 16 questions on a 7-point scale, ranging from 0 (never bothered) to 6 (always bothered). The questionnaire is divided into 3 domains: symptoms (items 1 to 4), emotions (items 5 to 11), and functionality (items 12 to 16). An overall score is the average of the 3 domain scores. All domain scores will be linearly transformed to be in the range from 0 to 100. A score of 0 indicates that the skin condition has no impact on QoL, while a score of 100 indicates the worst possible impact.

    Measured: Up to approximately 60 Months

  9. Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Items-30 Scale Score

    The EORTC QLQ-C30 is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.

    Measured: Up to approximately 60 Months

  10. Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen

    Three questions regarding reactive and prophylactic management of AEs related to the amivantamab-containing regimen will be reported. These questions cover the type of prophylactic/reactive concomitant medication recommended by the treating physician, frequency of use, and the degree of impact on daily life due to use of the respective medication.

    Measured: Up to approximately 60 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start3 Dec 2025
  3. Primary completion19 Nov 2030 (estimated)
  4. Study completion17 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230691
Sponsor's protocol ID
61186372NSC4014
Other IDs
61186372NSC4014
Acronym
LEPIDOPTERA
Status last verified
Nov 2026
First submitted
14 Nov 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 90 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Italy, Germany, Spain, United Kingdom, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-World Time to Treatment Discontinuation (rwTTD) (time frame: Up to approximately 60 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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