A Real World Study of Participants With Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) (LuCaRTE)
2026년 6월 26일 업데이트: Janssen-Cilag Farmaceutica Ltda.
Characterization of the Population, Treatment Patterns and Outcomes of Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) - Multicenter Retrospective Cohort Study
This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation.
NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene.
The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
관찰
등록 (추정된)
250
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
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Adult participants (aged greater than or equal to [>=] 18 years) with a histologically or cytologically confirmed diagnosis of NSCLC, unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation.
설명
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022
- Diagnosed and treated at one of the participating study centers within the defined study period
Exclusion criteria:
- Participants who received any systemic cancer treatment outside the participating treatment centers
- Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma
- Participants enrolled in clinical trials during the study period.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLC
Participants with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC), unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation will be included in this cohort.
The existing secondary data from electronic health records (EHR) of these participants from approximately five selected Portuguese healthcare sites will be processed.
Each participant will be followed up from index date (date on which participant is included in study) up to 31 March 2026 or at censoring, No intervention will be provided as a part of this study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sociodemographic Characteristics: Age
기간: Baseline
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Age in years of the participants will be reported.
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Baseline
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Sociodemographic Characteristics: Sex
기간: Baseline
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Sex (male, female) of the participants will be reported.
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Baseline
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Sociodemographic Characteristics: Weight
기간: Baseline
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Weight (in kilograms [kg]) of the participants will be reported.
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Baseline
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Sociodemographic Characteristics: Smoking Status
기간: Baseline
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Participants smoking status that is current or former smoker will be reported.
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Baseline
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Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status
기간: Baseline
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ECOG performance status of the participants will be reported.
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Baseline
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Sociodemographic Characteristics: Disease Histopathology
기간: Baseline
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Number of participants based on disease histopathology will be reported.
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Baseline
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Sociodemographic Characteristics: Type of Mutation
기간: Baseline
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Number of participants based on type of mutation will be reported.
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Baseline
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Sociodemographic Characteristics: Disease Stage
기간: Baseline
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Number of participants based on the stage of disease will be reported.
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Baseline
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Sociodemographic Characteristics: Cancer Metastasis
기간: Baseline
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Number of participants based on cancer metastasis will be reported.
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Baseline
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EGFR Mutation Prevalence
기간: Up to approximately 7 years 9 months
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Number of participants with EGFR mutations will be reported.
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Up to approximately 7 years 9 months
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Percentage of Participants by Type of Mutation of EGFR
기간: Up to approximately 7 years 9 months
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Percentage of participants by type of mutation of EGFR will be reported.
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Up to approximately 7 years 9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of EGFR Mutations
기간: Up to approximately 7 years 9 months
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Frequency of EGFR mutations will be reported.
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Up to approximately 7 years 9 months
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Number of Participants by Treatment Options
기간: Up to approximately 7 years 9 months
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Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported.
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Up to approximately 7 years 9 months
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Real-World Overall Survival (RW-OS)
기간: Up to approximately 7 years 9 months
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RW-OS is defined as time elapsed between index date and date of death from any cause.
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Up to approximately 7 years 9 months
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Real-World Progression-Free Survival (RW-PFS)
기간: Up to approximately 7 years 9 months
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RW-PFS is defined as the time elapsed between the start of a new line of treatment to the date of documented disease progression or death from any cause, whichever occurs first.
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Up to approximately 7 years 9 months
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RW-PFS from First Line of Treatment (RW-PFS 2)
기간: Up to approximately 7 years 9 months
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RW-PFS 2 is defined as the time elapsed between the start of a first line of treatment to the date of documented second disease progression or death from any cause, whichever occurs first.
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Up to approximately 7 years 9 months
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Real-World Time on Treatment (RW-TOT)
기간: Up to approximately 7 years 9 months
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RW-TOT is defined as the time elapsed between the start date of a line of treatment to the date of treatment discontinuation for any reason.
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Up to approximately 7 years 9 months
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Real-World Time to Next Treatment (RW-TTNT)
기간: Up to approximately 7 years 9 months
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RW-TTNT is defined as the time elapsed between the start of a given line of treatment to the initiation of the subsequent line of systemic therapy.
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Up to approximately 7 years 9 months
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Real-World Overall Response Rate (RW-ORR)
기간: Up to approximately 7 years 9 months
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RW-ORR is defined as the percentage of participants whose cancer show partial response or complete response of all target lesions following a specific line of treatment.
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Up to approximately 7 years 9 months
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Number of Appointments
기간: Up to approximately 7 years 9 months
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Number of appointments related to NSCLC by line of treatment such as oncology, pulmonology, primary care, radio-oncology, thoracic surgery, nursing, psychology, nutrition, physiotherapy will be reported.
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Up to approximately 7 years 9 months
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Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures
기간: Up to approximately 7 years 9 months
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Number of participants receiving complementary diagnostic and therapeutic procedures and type of complementary diagnostic and therapeutic procedures received (for example, imaging, laboratory tests, biopsies, radiotherapy sessions, surgery, medication) will be reported.
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Up to approximately 7 years 9 months
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Number Participants with Emergency Room Visits Related to NSCLC
기간: Up to approximately 7 years 9 months
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Number of participants with emergency room visits related to NSCLC will be reported.
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Up to approximately 7 years 9 months
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Percentage of Participants Hospitalized
기간: Up to approximately 7 years 9 months
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Percentage of participants with at least one hospitalization will be reported.
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Up to approximately 7 years 9 months
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Number of Hospitalizations
기간: Up to approximately 7 years 9 months
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Total number of hospitalizations for the participants will be reported.
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Up to approximately 7 years 9 months
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Median Length of Stay
기간: Up to approximately 7 years 9 months
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Median length of stay in days per hospitalization will be reported.
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Up to approximately 7 years 9 months
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Net Costing
기간: Up to approximately 7 years 9 months
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The net cost of different treatment practices per participants will be reported.
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Up to approximately 7 years 9 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen-Cilag Farmaceutica, Lda. Clinical Trial, Janssen-Cilag Farmaceutica, Lda.
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 (추정된)
2026년 7월 30일
기본 완료 (추정된)
2026년 8월 30일
연구 완료 (추정된)
2026년 9월 30일
연구 등록 날짜
최초 제출
2026년 6월 26일
QC 기준을 충족하는 최초 제출
2026년 6월 26일
처음 게시됨 (실제)
2026년 7월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 26일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 61186372NSC4016 (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 www.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 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. .
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