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Gefitinib Long-term Survivor Study

2022년 3월 9일 업데이트: AstraZeneca

A Study of Clinical and Genomic Analysis on Long-term Survivors of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Patients With Gefitinib Treatment in China

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients

연구 개요

상태

종료됨

정황

EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

연구 유형

관찰

등록 (실제)

연락처 및 위치

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

연구 장소

중국
- Beijing
  - Beijing, Beijing, 중국
    - Research Site
- Fujian
  - Fuzhou, Fujian, 중국
    - Research Site
- Guangdong
  - Guangzhou, Guangdong, 중국
    - Research Site
- He Nan
  - Zhengzhou, He Nan, 중국
    - Research Site
- Hebei
  - Shijiazhuang, Hebei, 중국
    - Research Site
- Hubei
  - Wuhan, Hubei, 중국
    - Research Site
- Jiangsu
  - Nanjing, Jiangsu, 중국
    - Research Site
- Jilin
  - Changchun, Jilin, 중국
    - Research Site
- Liaoning
  - Shenyang, Liaoning, 중국
    - Research Site
- Shaanxi
  - XI An, Shaanxi, 중국
    - Research Site
- Shanghai
  - Shanghai, Shanghai, 중국
    - Research Site
- Shanxi
  - Taiyuan, Shanxi, 중국
    - Research Site
- Sichuan
  - Chengdu, Sichuan, 중국
    - Research Site
- Zhejiang
  - Hangzhou, Zhejiang, 중국
    - Research Site

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

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

설명

Inclusion Criteria:

For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:

Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
EGFR mutation positive
Patients who continuously received gefitinib for at least 3 years without evidence of PD
Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:

Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
EGFR mutation positive
Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

Exclusion Criteria:

For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.

For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled

1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Long-term survivors group (case) EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
Rapid PD group (control) EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	기간
Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors 기간: at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start	at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

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)

2016년 10월 31일

기본 완료 (실제)

2017년 7월 4일

연구 완료 (실제)

2017년 7월 4일

연구 등록 날짜

최초 제출

2016년 9월 12일

QC 기준을 충족하는 최초 제출

2016년 10월 11일

처음 게시됨 (추정)

2016년 10월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 9일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

EGFR mutation; non-small-cell lung cancer;

추가 관련 MeSH 약관

기타 연구 ID 번호

D7913R00020

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. .

EGFR Mutation Positive Advanced Non-small-cell Lung Cancer에 대한 임상 시험

Taichung Veterans General Hospital

완전한

EGFR 변이 진행성 비소세포폐암에서 EGFR-TKIs와 연관된 암 치료 관련 심장 기능 장애

심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제

대만
Fondazione del Piemonte per l'Oncologia

모병

생물학적, 유전적 및 체질적 요인과 비침습적 모니터링을 통한 개인별 암 위험 평가 연구 (PRO-ACTIVE)

유방암 | 난소 암 | 대장암 | 흑색종(피부암) | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung)

이탈리아

결과 측정	기간
Sex 기간: at time of Gefitinib treatment initiation,up to 10 years before study start	at time of Gefitinib treatment initiation,up to 10 years before study start
Age 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Pre-existing comorbidities at initiation of gefitinib therapy 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Cancer type and date of first ever cancer diagnosis 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Histological subtype 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
EGFR mutation status 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Smoking status 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
ECOG performance status at time of Gefitinib treatment initiation 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Starting dose 기간: at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons 기간: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib 기간: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Therapeutic agent name post-gefitinib discontinuation 기간: from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year	from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
Documented tumour response (complete or partial response or stable disease, according to RECIST) as determined by the treating physician by clinical judgment and/or imaging after first ever initiation of gefitinib 기간: from Gefitinib treatment initiation to study completion, up to 12 years	from Gefitinib treatment initiation to study completion, up to 12 years
Progression Free Survival (PFS) 기간: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
Overval survival (OS) 기간: from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years