GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
2019년 12월 19일 업데이트: Boehringer Ingelheim
An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.
This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations.
Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.
연구 개요
상세 설명
Study Design:
연구 유형
관찰
등록 (실제)
161
연락처 및 위치
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연구 장소
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Multiple Locations, 독일
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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
확률 샘플
연구 인구
NSCLC-EGFR mutation positive
설명
Inclusion criteria:
- EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
- Age >= 18 years
- No diagnostic or therapeutic measures beyond routine clinical practice are required
- Patients for whom the treating physician has decided to initiate treatment with GIOTRIF
- Written informed consent prior inclusion
Exclusion criteria:
- Contraindication for Afatinib according to the Summary of Product characteristics
- Participation in another clinical study until 30 days after end of treatment
- Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
- Previous treatment with an EGFR-tyrosine kinase inhibitor
- Patients not willing or not able to fill in quality of life questionnaires
- Patients with missing or impaired legal capacity
- Pregnancy
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 |
개입 / 치료 |
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아파티닙
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50, 40, 30 or 20 mg
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression Free Survival (PFS) Rate After 12 Months
기간: After 12 months
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The rate (probability) of being progression free after 12 months.
PFS is defined as the time from first administration of the trial drug until objective tumor progression or death.
The rate is the Kaplan-Meier estimated percent probability.
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After 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective Response Rate (ORR)
기간: From the initial dose of study drug until end of the treatment period, up to 48 months.
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Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response.
Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.
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From the initial dose of study drug until end of the treatment period, up to 48 months.
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Disease Control Rate (DCR)
기간: From the initial dose of study drug until end of the treatment period, up to 48 months.
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Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response.
CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate
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From the initial dose of study drug until end of the treatment period, up to 48 months.
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Progression Free Survival (PFS)
기간: From first administration of the trial drug until objective tumour progression or death, up to 48 months.
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PFS was measured from start of therapy until progression or death, whichever came first.
Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician.
One day was added to the corresponding date.
Patients without documented progression and not known to have died were censored at their date of last examination and one day was added.
Median was derived by Kaplan Meier methods.
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From first administration of the trial drug until objective tumour progression or death, up to 48 months.
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Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
기간: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
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Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
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From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
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Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
기간: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
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Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia.
Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.
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From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
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Treatment Duration
기간: From the initial dose of study drug until end of the treatment period, up to 48 months.
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Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.
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From the initial dose of study drug until end of the treatment period, up to 48 months.
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Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
기간: Up to 48 months
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Symptom control was evaluated for cough, dyspnea and pain.
Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured.
Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable.
Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30.
Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.
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Up to 48 months
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Percentage of Participants With Treatment Modification
기간: From the initial dose of study drug until end of the treatment period, up to 48 months.
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Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.
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From the initial dose of study drug until end of the treatment period, up to 48 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
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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)
2014년 3월 5일
기본 완료 (실제)
2018년 12월 31일
연구 완료 (실제)
2018년 12월 31일
연구 등록 날짜
최초 제출
2014년 1월 27일
QC 기준을 충족하는 최초 제출
2014년 1월 27일
처음 게시됨 (추정)
2014년 1월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 19일
마지막으로 확인됨
2019년 12월 1일
추가 정보
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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