A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
2015年3月24日 更新者：Hoffmann-La Roche
A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression.
Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
調査の概要
研究の種類
介入
入学 (実際)
51
段階
- フェーズ 4
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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Bangalore、インド、560027
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Chennai、インド、600035
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Delhi、インド、110085
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Hyderabad、インド、500 034
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Jaipur、インド、302 017
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Kolkata、インド、700026
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Nasik、インド、422005
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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 ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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
Participants received erlotinib 150 mg orally once a day for 48 weeks.
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Erlotinib was supplied as tablets.
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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Percentage of Participants With Progression-free Survival at Week 52
時間枠：From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
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A participant had progression-free survival if they did not have disease progression and were alive.
Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 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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Progression-free Survival (PFS)
時間枠：From the date of enrolment until the end of the study (up to 2 years, 6 months).
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PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline.
TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall Survival
時間枠：From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
時間枠：From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A CR was defined as the disappearance of all target lesions.
A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
All other lesions (or sites of disease) should be identified as non-target lesions.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With Disease Control
時間枠：From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD).
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started.
For non-TLs, SD was defined as the persistence of 1 or more lesions.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
A SLD for all TLs will be calculated and reported as the Baseline SLD.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 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
2011年3月1日
一次修了 (実際)
2013年9月1日
研究の完了 (実際)
2013年9月1日
試験登録日
最初に提出
2010年10月28日
QC基準を満たした最初の提出物
2010年10月28日
最初の投稿 (見積もり)
2010年10月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年3月30日
QC基準を満たした最後の更新が送信されました
2015年3月24日
最終確認日
2015年3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。