Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation (INNOVATE)
Intercalated Combination of Chemotherapy and Erlotinib in 1st Line Setting for Patients Advanced Stage Non-small-cell Lung Cancer With Low Abundant Activating EGFR Mutation(INNOVATE)
調査の概要
詳細な説明
Primary therapy stage:
Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.
Maintenance therapy stage:
Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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-
Guangdong
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Guangzhou、Guangdong、中国、510080
- Guangdong General Hospital & Guangdong Academy of Medical Sciences
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods.
Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients must have measurable disease according to the RECIST (version 1.1) criteria.
- Life expectancy of at least 12 weeks.
- Age ≥ 18 years.
- Written (signed) informed Consent to participate in the study.
- Adequate organ function as defined by the following criteria:
Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.
Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.
Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
- For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria:Patients with prior chemotherapy or systemic anti-cancer therapy including target therapy targeting HER family members (such as erlotinib, gefitinib, cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- Nursing or lactating women.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Unwilling to write informed consent to participate in the study.
- Patients who is unwilling to accept the follow-up.
研究計画
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：なし
- 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 |
|---|---|
|
実験的：chemotherapy and erlotinib
Intercalated combination of chemotherapy and erlotinib in 1st line setting for patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation
|
Primary therapy stage: Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle. Maintenance therapy stage: Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.
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 |
|---|---|---|
|
Progression free survival defined by imagery methods
時間枠：8 weeks
|
From start of anti-cancer therapy untill progression or death
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8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Toxicities related to anti-cancer therapy
時間枠：8 weeks
|
From start of anti-cancer therapy till progression of death
|
8 weeks
|
協力者と研究者
捜査官
- スタディチェア：Yi-Long Wu、Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences
- 主任研究者：Zhen Wang, PhD、Guangdong General Hospital & Guangdong Academy of Medical Sciences
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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