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A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)

2015년 11월 3일 업데이트: AstraZeneca

A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study

This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

연구 개요

상태

완전한

정황

Locally Advanced or Metastatic EGFR Mutated NSCLC.

상세 설명

This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

연구 유형

관찰

등록 (예상)

200

연락처 및 위치

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연구 장소

대만
- - Chiayi, 대만
  - Kaohsiung, 대만
  - Taichung, 대만
  - Taipei, 대만
  - Taipei, 대만
    - Research Site
  - Tao Yuan, 대만

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

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study

설명

Inclusion Criteria:

Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
Female or male aged ≧20 years
Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:

1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration 기간: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.	From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

2차 결과 측정

결과 측정	측정값 설명	기간
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 기간: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of progression-free survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. PFS is defined as the time interval (in weeks) from the start date of a given treatment to the date of disease progression or death, respectively, which one is observed first. Subjects who did not progress or die without a reported progression will be censored on the date of their last tumor assessment.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 기간: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of overall survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. OS is defined as the time interval (in weeks) from the beginning of treatment until the date when death or lost to follow up is observed. For those subjects who have not died or lost to follow-up, survival duration will be censored at the last date the subject was known to be alive.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 기간: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome about response rate and the proportion of response rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. The best response during treatment sequences is determined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 기간: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of disease control rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. Disease Control Rate is defined as patients who are respond to treatment (including CR-complete respond, PR-partial respond or SD- Stable Disease).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy. 기간: Between the initial EGFR-TKI therapy and first time chemotherapy.	Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.	Between the initial EGFR-TKI therapy and first time chemotherapy.
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment). 기간: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics. 기간: EGFR-TKI initial and re-administration	Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics (including demographics, histology, disease stage, sites of metastasis, ECOG PS) or EGFR TKI treatment characteristics (including EGFR mutation pattern, response to initial EGFR TKI or not, length of duration between first and second EGFR-TKI treatment)	EGFR-TKI initial and re-administration
overall survival (OS), plasma CEA level and chemotherapy regimens ever used. 기간: between first time chemotherapy and EGFR-TKI re-administration	Explore overall survival (OS), plasma CEA level and chemotherapy regimens ever used between first time chemotherapy and EGFR-TKI re-administration (including the types and number of chemotherapy regimens, and treatment duration) for those patients who have the above data available.	between first time chemotherapy and EGFR-TKI re-administration
image peer review to evaluate tumour size retrospectively in different sequences of treatment 기간: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.	If the images are available, conduct image peer review to evaluate tumour size retrospectively in different sequences of treatment: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment. Peer review time point includes baseline, best response and progression of last image while stopping treatment at each treatment mentioned above.	(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review 기간: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.	Evaluate the reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review and compare the difference of reason(s) for the treatment change between initiatial evaluation and after peer review.	Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

수사관

수석 연구원: Te-Chun Hsia, China Medical University Hospital
수석 연구원: Yuh-Min Chen, Taipei Veterans General Hospital, Taiwan
수석 연구원: Gee-Chen Chang, Veterans General Hospital -Taichung
수석 연구원: Chong-Jen Yu, National Taiwan University Hospital
수석 연구원: Cheng-Ta Yang, Chang Gung Memorial Hospital
수석 연구원: Meng-Chih Lin, Chang-Gung Memorial Hospital Kaohsiung
수석 연구원: Ying-Huang Tsai, Chang-Gung Memorial Hospital ChiaYi

간행물 및 유용한 링크

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유용한 링크

CSR_Synopsis_NIS-OTW-XXX-2013_1

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

2013년 12월 1일

기본 완료 (실제)

2014년 8월 1일

연구 완료 (실제)

2014년 8월 1일

연구 등록 날짜

최초 제출

2013년 9월 30일

QC 기준을 충족하는 최초 제출