이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

실제 임상 환경에서 EGFR 변이 진행성 비소세포폐암(NSCLC) 환자의 임상 결과에 관한 연구 (LEPIDOPTERA)

2026년 11월 2일 업데이트: Janssen Research & Development, LLC

승인된 아미반타맙 함유 요법을 표준 임상 관행에 따라 치료받은 EGFR 변이 진행성 비소세포폐암(NSCLC) 환자의 임상 결과에 대한 전향적, 다국가, 관찰 연구

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).

연구 개요

상태

모병

정황

암종, 비소세포폐

연구 유형

관찰

등록 (추정된)

380

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Study Contact
전화번호: 844-434-4210
이메일: Participate-In-This-Study1@its.jnj.com

연구 장소

독일
- - Aschaffenburg, 독일, 63739
    - 모병
    - MVZ am Klinikum Aschaffenburg Onkologie
  - Bielefeld, 독일, 33611
    - 모병
    - Evangelisches Klinikum Bethel
  - Bochum, 독일, 44791
    - 모병
    - Augusta Kliniken Bochum Hattingen
  - Bremen, 독일, 28325
    - 모병
    - Gesundheit Nord - Klinikverbund Bremen
  - Chemnitz, 독일, 09113
    - 모병
    - Klinikum Chemnitz gGmbH
  - Cologne, 독일, 50677
    - 모병
    - Haematologie u Onkologie Koeln MV Zentrum
  - Cologne, 독일, 51109
    - 모병
    - Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
  - Düsseldorf, 독일, 40489
    - 모병
    - Florence Nightingale Krankenhaus
  - Essen, 독일, 45147
    - 모병
    - Universitaetsklinikum Essen
  - Essen, 독일, 45136
    - 모병
    - Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
  - Hamburg, 독일, 20249
    - 모병
    - Facharztzentrum Eppendorf
  - Hanover, 독일, 30625
    - 모병
    - Medizinische Hochschule Hannover
  - Hanover, 독일, 30161
    - 모병
    - Onkologie am Raschplatz
  - Hanover, 독일, 30449
    - 모병
    - Klinikum Region Hannover Klinikum Siloah
  - Hemer, 독일, 58675
    - 모병
    - Lungenklinik Hemer
  - Konstanz, 독일, 78464
    - 모병
    - Klinikum Konstanz
  - Landshut, 독일, 84034
    - 모병
    - LA Regio Kliniken Klinik Landshut Mitte
  - Neuss, 독일, 41462
    - 모병
    - MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
  - Recklinghausen, 독일, 45659
    - 모병
    - Knappschaft Kliniken MVZ Nord GmbH
  - Solingen, 독일, 42699
    - 모병
    - Hospital Bethanien Solingen
  - Stolberg, 독일, 52222
    - 모병
    - MVZ Onkologie Groschek Keller
  - Ulm, 독일, 89081
    - 모병
    - Bundeswehrkrankenhaus Ulm
벨기에
- - Brussels, 벨기에, 1090
    - 모병
    - UZ Brussel
  - Edegem, 벨기에, 2650
    - 모병
    - UZ Antwerpen
  - Hasselt, 벨기에, 3500
    - 모병
    - Jessa Ziekenhuis
  - Kortrijk, 벨기에, 8500
    - 모병
    - Az Groeninge
  - La Louvière, 벨기에, 7100
    - 모병
    - Chu Helora Hospital La Louviere Site Jolimont
  - Liège, 벨기에, 4000
    - 모병
    - CHU de Liege
  - Sint-Niklaas, 벨기에, 9100
    - 모병
    - Vitaz
스페인
- - A Coruña, 스페인, 15006
    - 모병
    - Hosp Univ A Coruna
  - Burgos, 스페인, 09006
    - 모병
    - Hosp. Univ. de Burgos
  - Córdoba, 스페인, 14004
    - 모병
    - Hosp Reina Sofia
  - Jerez de la Frontera, 스페인, 11407
    - 모병
    - Hosp. de Jerez de La Frontera
  - Lugo, 스페인, 27003
    - 모병
    - Hosp. Univ. Lucus Augusti
  - Málaga, 스페인, 29011
    - 모병
    - Hosp Regional Univ de Malaga
  - Ourense, 스페인, 32005
    - 모병
    - Complexo Hosp. Univ. de Ourense
  - Palma de Mallorca, 스페인, 07120
    - 모병
    - Hosp. Univ. Son Espases
  - Santiago de Compostela, 스페인, 15706
    - 모병
    - Hosp. Clinico Univ. de Santiago
  - Seville, 스페인, 41013
    - 모병
    - Hospital Universitario Virgen Rocio
  - Valladolid, 스페인, 47003
    - 모병
    - Hosp. Clinico Univ. de Valladolid
  - Vigo, 스페인, 36312
    - 모병
    - Hosp. Alvaro Cunqueiro
영국
- - Bath, 영국, BA1 3NG
    - 모병
    - Royal United Hospital
  - Cardiff, 영국, CF14 2TL
    - 모병
    - Velindre Hospital
  - Eastbourne, 영국, BN21 2UD
    - 모병
    - Eastbourne District General Hospital
  - Guildford, 영국, GU2 7XX
    - 모병
    - Royal Surrey County Hospital NHS Trust
  - Heath Town, 영국, WV10 0QP
    - 모병
    - New Cross Hospital
  - London, 영국, SW3 6JJ
    - 모병
    - Royal Marsden Hospital
  - Manchester, 영국, M20 4BX
    - 모병
    - The Christie NHS Foundation Trust Christie Hospital
  - Sutton, 영국, SM2 5PT
    - 모병
    - Royal Marsden Hospital (Sutton)
오스트리아
- - Graz, 오스트리아, 8036
    - 모병
    - University Hospital Graz
  - Klagenfurt, 오스트리아, 9020
    - 모병
    - Klinikum Klagenfurt am Worthersee
  - Natters, 오스트리아, 6161
    - 모병
    - Landeskrankenhaus Hochzirl Natters
이스라엘
- - Petah Tikva, 이스라엘, 4941492
    - 모병
    - Rabin Medical Center
  - Ramat Gan, 이스라엘, 5262000
    - 모병
    - Sheba Medical Center
  - Tel Aviv, 이스라엘, 6971028
    - 모병
    - Assuta MC
이탈리아
- - Avellino, 이탈리아, 83100
    - 모병
    - Ospedale San Giuseppe Moscati di Avellino
  - Aviano, 이탈리아, 33081
    - 모병
    - CRO IRCCS Istituto Nazionale Tumori
  - Bari, 이탈리아, 70124
    - 모병
    - Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
  - Bergamo, 이탈리아, 24127
    - 모병
    - ASST Papa Giovanni XXIII Bergamo
  - Brescia, 이탈리아, 25123
    - 모병
    - ASST Spedali Civili Brescia
  - Candiolo, 이탈리아, 10060
    - 모병
    - Istituto di Candiolo, IRCCS
  - Catania, 이탈리아, 95123
    - 모병
    - PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  - Catanzaro, 이탈리아, 88100
    - 모병
    - Azienda Ospedaliera Pugliese Ciaccio Catanzaro
  - Genova, 이탈리아, 16132
    - 모병
    - Ospedale Policlinico San Martino IRCCS
  - Lecce, 이탈리아, 73100
    - 모병
    - Azienda Ospedaliera ''Vito Fazzi''
  - Milan, 이탈리아, 20162
    - 모병
    - ASST Grande Ospedale Metropolitano Niguarda
  - Milan, 이탈리아, 20132
    - 모병
    - San Raffaele Hospital
  - Milan, 이탈리아, 20133
    - 모병
    - Istituto Dei Tumori Di Milano
  - Milan, 이탈리아, 20141
    - 모병
    - European Institute of Oncology
  - Monza, 이탈리아, 20900
    - 모병
    - San Gerardo Hospital
  - Naples, 이탈리아, 80131
    - 모병
    - Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  - Naples, 이탈리아, 80131
    - 모병
    - Universita degli Studi della Campania Luigi Vanvitelli
  - Novara, 이탈리아, 28100
    - 모병
    - Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
  - Olbia, 이탈리아, 07026
    - 모병
    - ASL Gallura - Ospedale Giovanni Paolo II
  - Orbassano, 이탈리아, 10043
    - 모병
    - Aou San Luigi Gonzaga
  - Palermo, 이탈리아, 90127
    - 모병
    - Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  - Palermo, 이탈리아, 90146
    - 모병
    - A.O.R Villa Sofia Cervello
  - Parma, 이탈리아, 43126
    - 모병
    - Azienda Ospedaliero-Universitaria Di Parma
  - Pisa, 이탈리아, 56124
    - 모병
    - Azienda Ospedaliero Universitaria Pisana
  - Ravenna, 이탈리아, 48121
    - 모병
    - U.O.C. Ematologia Ospedale S. Maria delle Croci
  - Roma, 이탈리아, 00168
    - 모병
    - Fondazione Policlinico Universitario A Gemelli IRCCS
  - Roma, 이탈리아, 128
    - 모병
    - Campus Bio Medico di Roma
  - Rome, 이탈리아, 00144
    - 모병
    - Istituto Nazionale Tumori Regina Elena
  - Sassari, 이탈리아, 07100
    - 모병
    - Azienda Ospedaliero Universitaria di Sassari
  - Torrette-Ancona, 이탈리아, 60126
    - 모병
    - Ospedali Riuniti Di Ancona
  - Urbino, 이탈리아, 61121
    - 모병
    - Azienda Sanitaria Territoriale Pesaro Urbino
체코
- - Brno, 체코, 625 00
    - 모병
    - Fakultni nemocnice Brno
  - Hradec Králové, 체코, 500 05
    - 모병
    - Fakultni nemocnice Hradec Kralove
  - Olomouc, 체코, 77900
    - 모병
    - Fakultni nemocnice Olomouc
  - Prague, 체코, 140 59
    - 모병
    - Fakultni Thomayerova nemocnice

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

The study population will include participants with advanced NSCLC.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Real-World Time to Treatment Discontinuation (rwTTD) 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Real-World Progression-Free Survival (rwPFS) 기간: 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) 기간: 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) 기간: 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) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

수사관

연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 3일

기본 완료 (추정된)

2030년 11월 19일

연구 완료 (추정된)

2030년 12월 17일

연구 등록 날짜

최초 제출

2025년 11월 14일

QC 기준을 충족하는 최초 제출

2025년 11월 14일

처음 게시됨 (실제)

2025년 11월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

61186372NSC4014
61186372NSC4014 (기타 식별자: Janssen Research & Development, LLC)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .