A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
2015年7月23日 更新者：Hoffmann-La Roche
A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy.
Patients must be current smokers and not intending to stop smoking during the study.
Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses.
Treatment will continue until disease progression.
調査の概要
研究の種類
介入
入学 (実際)
315
段階
- フェーズ 3
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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Cairo、エジプト、11796
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Cairo、エジプト
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Amsterdam、オランダ、1007 MB
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Breda、オランダ、4818 CK
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Nieuwegein、オランダ、3435 CM
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Zwolle、オランダ、8011 JW
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Baden、スイス、5404
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Basel、スイス、4031
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Bern、スイス、3011
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Fribourg、スイス、1708
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Barcelona、スペイン、08035
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Barcelona、スペイン、08041
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Madrid、スペイン、28040
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Madrid、スペイン、28041
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Malaga、スペイン、29010
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Sevilla、スペイン、41013
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Valencia、スペイン、46009
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Barcelona
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Sabadell, Barcelona、Barcelona、スペイン、08208
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Hillerod、デンマーク、3400
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København、デンマーク、2100
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Naestved、デンマーク、4700
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Roskilde、デンマーク、4000
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Berlin、ドイツ、13125
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Berlin、ドイツ、14165
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Essen、ドイツ、45122
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Gauting、ドイツ、82131
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Grosshansdorf、ドイツ、22927
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Hannover、ドイツ、30625
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Hannover、ドイツ、30659
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Immenhausen、ドイツ、34376
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Lostau、ドイツ、39291
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München、ドイツ、81925
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Nürnberg、ドイツ、90419
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Rheine、ドイツ、48431
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Villingen-Schwenningen、ドイツ、78052
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Wuerselen、ドイツ、52146
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Wuppertal、ドイツ、42283
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Caen、フランス、14076
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Limoges、フランス、87042
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Marseille、フランス、13915
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Paris、フランス、75014
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Paris、フランス、75908
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Paris、フランス、75674
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Pontoise、フランス、95300
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Ankara、七面鳥、06200
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Ankara、七面鳥、06000
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Eskisehir、七面鳥、26480
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Gaziantep、七面鳥、27310
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Izmir、七面鳥、35340
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Izmir、七面鳥、35110
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Konya、七面鳥、42050
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Beijing、中国、100071
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Changchun、中国、130012
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Chengdu、中国、610041
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Fuzhou、中国、350014
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Guangzhou、中国、510030
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Nanjing、中国、210009
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Nanning、中国、530021
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Shanghai、中国、200433
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Shanghai、中国、200030
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Shenyang、中国、110001
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Tianjin、中国、300060
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Wuhan、中国、430030
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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
説明
Inclusion Criteria:
- Adult patients aged ≥18 years
- inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥12 weeks
- Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria:
- Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
- Radiotherapy within 28 days prior to enrollment
- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
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Single daily oral dose
他の名前：
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実験的：Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
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Single daily oral dose
他の名前：
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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)
時間枠：Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
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PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
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Progression-Free Survival (PFS) at the End of Study
時間枠：Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 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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Overall Survival (OS)
時間枠：Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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OS defined as the time from randomization to the date of death due to any cause.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Overall Response Rate (ORR)
時間枠：Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response).
Patients with no tumor assessment after the start of study treatment were to be considered as non-responders.
The percentage of participants in each best response category is presented.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Disease Control Rate (DCR)
時間枠：Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans.
Disease control rates were measured according to RECIST version 1.1 criteria.
A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks.
Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease.
The percentage of participants with Disease Control is presented.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Time to Progression (TTP)
時間枠：Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression.
Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
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Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
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Number of Participants With Adverse Events (AEs) at the End of the Study
時間枠：Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death. |
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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Overall Survival (OS) at the End of Study
時間枠：Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
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OS defined as the time from randomization to the date of death due to any cause.
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Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 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
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
2010年10月1日
一次修了 (実際)
2013年10月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2010年8月16日
QC基準を満たした最初の提出物
2010年8月16日
最初の投稿 (見積もり)
2010年8月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年8月19日
QC基準を満たした最後の更新が送信されました
2015年7月23日
最終確認日
2015年7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。