Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC
A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
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:
- Age：18~70 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
- Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
- EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
- No indications for radiation therapy
- Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
- Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI
Exclusion Criteria:
- Small Cell Lung Cancer
- central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
- Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
- have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
- with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
- get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
- Have suffered from hemorrhagic disease or coagulation dysfunction
- diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
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：非ランダム化
- 介入モデル：階乗代入
- 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：Non-squamous cell lung cancer
Anlotinib combined with pemetrexed and carboplatin, phase I Anlotinib combined with pemetrexed and carboplatin, phase II |
Non-squamous cell lung cancer, Anlotinib Plus PC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin
他の名前：
Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
他の名前：
|
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実験的：Squamous cell lung cancer
Anlotinib combined with paclitaxel and carboplatin, phase I Anlotinib combined with paclitaxel and carboplatin, phase II |
Squamous cell lung cancer, Anlotinib plus TC This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin
他の名前：
Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
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 |
|---|---|---|
|
Progress free survival (PFS)
時間枠：From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months
|
progression free survival
|
From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：each 21 days up to the toxicity or PD (up to 24 months)
|
Objective Response Rate
|
each 21 days up to the toxicity or PD (up to 24 months)
|
|
Disease Control Rate (DCR)
時間枠：each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Disease Control Rate
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
|
Overall Survival (OS)
時間枠：From enrollment until death (up to 36 months)
|
Overall survival
|
From enrollment until death (up to 36 months)
|
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)
時間枠：Time Frame: each 21 days up to the toxicity or PD (up to 36 months)
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
|
Time Frame: each 21 days up to the toxicity or PD (up to 36 months)
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NCC201807006
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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