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

August 27, 2026 updated by: Janssen Research & Development, LLC

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • University Hospital Graz
      • Klagenfurt, Austria, 9020
        • Recruiting
        • Klinikum Klagenfurt Am Worthersee
      • Natters, Austria, 6161
        • Recruiting
        • Landeskrankenhaus Hochzirl Natters
  • Belgium
      • Brussels, Belgium, 1090
        • Recruiting
        • UZ Brussel
      • Edegem, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis
      • Kortrijk, Belgium, 8500
        • Recruiting
        • AZ Groeninge
      • La Louvière, Belgium, 7100
        • Recruiting
        • Chu Helora Hospital La Louvière Site Jolimont
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liege
      • Sint-Niklaas, Belgium, 9100
        • Recruiting
        • Vitaz
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 77900
        • Recruiting
        • Fakultni Nemocnice Olomouc
      • Prague, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova nemocnice
  • Germany
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • MVZ am Klinikum Aschaffenburg Onkologie
      • Bielefeld, Germany, 33611
        • Recruiting
        • Evangelisches Klinikum Bethel
      • Bochum, Germany, 44791
        • Recruiting
        • Augusta Kliniken Bochum Hattingen
      • Chemnitz, Germany, 09113
        • Recruiting
        • Klinikum Chemnitz gGmbH
      • Cologne, Germany, 50677
        • Recruiting
        • Haematologie u Onkologie Koeln MV Zentrum
      • Cologne, Germany, 51109
        • Recruiting
        • Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen
      • Essen, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
      • Hamburg, Germany, 20249
        • Recruiting
        • Facharztzentrum Eppendorf
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Hanover, Germany, 30161
        • Recruiting
        • Onkologie am Raschplatz
      • Hanover, Germany, 30449
        • Recruiting
        • Klinikum Region Hannover Klinikum Siloah
      • Hemer, Germany, 58675
        • Recruiting
        • Lungenklinik Hemer
      • Konstanz, Germany, 78464
        • Recruiting
        • Klinikum Konstanz
      • Landshut, Germany, 84034
        • Recruiting
        • LA Regio Kliniken Klinik Landshut Mitte
      • Neuss, Germany, 41462
        • Recruiting
        • MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
      • Recklinghausen, Germany, 45659
        • Recruiting
        • Knappschaft Kliniken MVZ Nord GmbH
      • Solingen, Germany, 42699
        • Recruiting
        • Hospital Bethanien Solingen
      • Stolberg, Germany, 52222
        • Recruiting
        • MVZ Onkologie Groschek Keller
      • Ulm, Germany, 89081
        • Recruiting
        • Bundeswehrkrankenhaus Ulm
  • Israel
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • Sheba medical center
      • Tel Aviv, Israel, 6971028
        • Recruiting
        • Assuta MC
  • Italy
      • Avellino, Italy, 83100
        • Recruiting
        • Ospedale San Giuseppe Moscati di Avellino
      • Aviano, Italy, 33081
        • Recruiting
        • CRO IRCCS Istituto Nazionale Tumori
      • Bari, Italy, 70124
        • Recruiting
        • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
      • Bergamo, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII Bergamo
      • Brescia, Italy, 25123
        • Recruiting
        • ASST Spedali Civili Brescia
      • Candiolo, Italy, 10060
        • Recruiting
        • Istituto di Candiolo, IRCCS
      • Catania, Italy, 95123
        • Recruiting
        • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
      • Catanzaro, Italy, 88100
        • Recruiting
        • Azienda Ospedaliera Pugliese Ciaccio Catanzaro
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS
      • Lecce, Italy, 73100
        • Recruiting
        • Azienda Ospedaliera ''Vito Fazzi''
      • Milan, Italy, 20141
        • Recruiting
        • European Institute of Oncology
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 20132
        • Recruiting
        • San Raffaele Hospital
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Dei Tumori Di Milano
      • Monza, Italy, 20900
        • Recruiting
        • San Gerardo Hospital
      • Naples, Italy, 80131
        • Recruiting
        • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
      • Naples, Italy, 80131
        • Recruiting
        • Università degli Studi della Campania Luigi Vanvitelli
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
      • Olbia, Italy, 07026
        • Recruiting
        • ASL Gallura - Ospedale Giovanni Paolo II
      • Orbassano, Italy, 10043
        • Recruiting
        • AOU San Luigi Gonzaga
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Palermo, Italy, 90146
        • Recruiting
        • A.O.R Villa Sofia Cervello
      • Parma, Italy, 43126
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Parma
      • Pisa, Italy, 56124
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Ravenna, Italy, 48121
        • Recruiting
        • U.O.C. Ematologia Ospedale S. Maria delle Croci
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • Roma, Italy, 128
        • Recruiting
        • Campus Bio Medico di Roma
      • Rome, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
      • Sassari, Italy, 07100
        • Recruiting
        • Azienda Ospedaliero Universitaria di Sassari
      • Torrette-Ancona, Italy, 60126
        • Recruiting
        • Ospedali Riuniti di Ancona
      • Urbino, Italy, 61121
        • Recruiting
        • Azienda Sanitaria Territoriale Pesaro Urbino
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hosp Reina Sofia
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • Hosp. de Jerez de La Frontera
      • Lugo, Spain, 27003
        • Recruiting
        • Hosp. Univ. Lucus Augusti
      • Málaga, Spain, 29011
        • Recruiting
        • Hosp Regional Univ de Malaga
      • Ourense, Spain, 32005
        • Recruiting
        • Complexo Hosp. Univ. de Ourense
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • Hosp. Univ. Son Espases
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hosp. Clinico Univ. de Santiago
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Rocio
      • Valladolid, Spain, 47003
        • Recruiting
        • Hosp. Clinico Univ. de Valladolid
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • Royal United Hospital
      • Cardiff, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Hospital
      • Eastbourne, United Kingdom, BN21 2UD
        • Recruiting
        • Eastbourne District General Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital NHS Trust
      • Heath Town, United Kingdom, WV10 0QP
        • Recruiting
        • New Cross Hospital
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust Christie Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants with advanced NSCLC.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-World Time to Treatment Discontinuation (rwTTD)
Time Frame: Up to approximately 60 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-World Progression-Free Survival (rwPFS)
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Real-World Time to Next Treatment (rwTTNT)
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Real-World Overall Survival (rwOS)
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Real-World Time to Subsequent Treatment Discontinuation (rwTTD2)
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Number of Participants with Adverse Events (AEs) by Severity
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy
Time Frame: Up to approximately 60 Months
Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported.
Up to approximately 60 Months
Number of Participants Using Concomitant Medications
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
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
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months
Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen
Time Frame: Up to approximately 60 Months
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.
Up to approximately 60 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

November 19, 2030

Study Completion (Estimated)

December 17, 2030

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61186372NSC4014 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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