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Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

2019년 6월 27일 업데이트: Boehringer Ingelheim

An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

542

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 대만
      • Kaohsiung, 대만, 824
        • E-Da Hospital
      • Tainan, 대만, 704
        • NCKUH
      • Taipei, 대만, 11490
        • Tri-Service General Hospital
      • Taoyuan County, 대만, 333
        • Chang-Gung Memorial Hospital, Linkou
  • 싱가포르
      • Singapore, 싱가포르, 169610
        • National Cancer Centre
  • 인도
      • Bangalore, 인도, 560052
        • Vikram Hospital
      • Bengaluru, 인도, 560027
        • HCG Hospital
      • Calicut, 인도, 673002
        • P VS Hospital Pvt Ltd
      • Chennai, 인도, 600031
        • V S Hospital
      • Delhi, 인도, 110092
        • Max Super Speciality Hospital, Delhi
      • Hyderabad, 인도, 500004
        • Global Hospitals
      • Hyderabad, 인도, 500034
        • Basavatarakam Indo - American Cancer Hospital & Research Ins
      • Jaipur, 인도, 302004
        • SEAROC Cancer Centre
      • Kolkata,West Bengal, 인도, 700053
        • B. P. Poddar Hospital & Medial Research Ltd
      • Madurai, 인도, 625 020
        • Asirvatham Multispeciality Hospital
      • Maharashtra, 인도, 422 004
        • Curie Manavata Cancer Centre
      • Maharashtra, 인도, 422005
        • Shatabdi Superspeciality Hospital
      • Mumbai, 인도, 400010
        • Prince Aly Khan Hospital
      • Pune, 인도, 411001
        • Ruby Hall Clinic
  • 중국
      • Beijing, 중국, 100071
        • 307 Hospital of PLA
      • Beijing, 중국, 100142
        • Beijing Cancer Hospital
      • Beijing, 중국, 100853
        • Chinese PLA General Hospital
      • Changchun, 중국
        • Jilin Province Cancer Hospital
      • Guangzhou, 중국, 510080
        • Guangdong Provincial People's Hospital
      • Hangzhou, 중국, 310022
        • Zhejiang Cancer Hospital
      • Linyi, 중국, 276002
        • Lin Yi Tumor Hospital
      • Nanjing, 중국, 210000
        • Jiangsu Cancer Hospital
      • Shanghai, 중국, 200030
        • Shanghai Chest Hospital
      • Shanghai, 중국, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, 중국, 200433
        • Shanghai Pulmonary Hospital
      • Tianjin, 중국, 300060
        • Tianjin Medical University Cancer Institute and Hospital
  • 홍콩
      • Hong Kong, 홍콩
        • Queen Mary Hospital
      • Shatin, 홍콩
        • Prince of Wales Hospital

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

설명

Inclusion criteria:

  • locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
  • presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
  • male or female patients age 18 years or older (For India only, male or female patients age >=18 years and <=75 years)

  • adequate organ function, defined as all of the following:

    1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
    2. Platelet count >75,000/mm3
    3. Serum creatinine < 1.5 times of the upper limit of normal
    4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
    5. Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.

Exclusion criteria:

  • prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
  • use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)

  • radiotherapy within 4 weeks prior to drug administration except as follows:

    1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
    2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
  • known hypersensitivity to afatinib or any of its excipients
  • history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
  • Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.

  • childbearing potential (see Section 4.2.3) who:

    1. are nursing or
    2. are pregnant or
    3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
  • history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
  • previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
  • requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
  • known pre-existing interstitial lung disease
  • presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
  • Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
  • meningeal carcinomatosis
  • symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication)

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Afatinib
Patient will receive afatinib once daily
의약품: Afatinib
Patient will receive afatinib once daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Serious Adverse Events (SAEs)
기간: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with serious adverse events (SAEs).
From first drug administration up to 28 days after last drug administration, up to 1624 days.

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Symptomatic Progression (TTSP)
기간: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
기간: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with drug-related (afatinib-related) adverse events.
From first drug administration up to 28 days after last drug administration, up to 1624 days.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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)

2013년 9월 30일

기본 완료 (실제)

2018년 7월 6일

연구 완료 (실제)

2018년 7월 6일

연구 등록 날짜

최초 제출

2013년 9월 25일

QC 기준을 충족하는 최초 제출

2013년 9월 26일

처음 게시됨 (추정)

2013년 10월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 6월 27일

마지막으로 확인됨

2019년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1200.66

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