GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
2019年12月19日 更新者：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.
調査の概要
詳細な説明
Study Design:
研究の種類
観察的
入学 (実際)
161
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Multiple Locations、ドイツ
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
NSCLC-EGFR mutation positive
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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アファチニブ
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50, 40, 30 or 20 mg
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Progression Free Survival (PFS) Rate After 12 Months
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective Response Rate (ORR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年3月5日
一次修了 (実際)
2018年12月31日
研究の完了 (実際)
2018年12月31日
試験登録日
最初に提出
2014年1月27日
QC基準を満たした最初の提出物
2014年1月27日
最初の投稿 (見積もり)
2014年1月28日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月9日
QC基準を満たした最後の更新が送信されました
2019年12月19日
最終確認日
2019年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
がん、非小細胞肺の臨床試験
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