Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment (Aurora003)
A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1: Aged 18-75 years, without gender restriction.
2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.
3: Has received at least two lines of prior systemic antitumor therapy.
4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 100×10⁹/L; hemoglobin (Hb) ≥ 90 g/L. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
7: Expected survival time ≥ 3 months.
8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.
Exclusion Criteria:
1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).
3: Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).
4: Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).
5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).
6: Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment.
7: History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies.
8: Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.
9: Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).
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：lomustine combined with anlotinib
Oral lomustine 60 mg/m² once daily on day 1 every 6 weeks, combined with oral anlotinib.
The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks.
|
Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks
Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle
|
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 |
|---|---|---|
|
Objective Response Rate
時間枠：Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
|
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
有害事象 (AE)
時間枠：インフォームドコンセントの署名から研究完了および安全性追跡調査まで、最大約24ヶ月間評価されます
|
すべての新規または悪化した好ましくない医学的事象を記録し、CTCAE 5.0に従ってグレードと発生率を計算する
|
インフォームドコンセントの署名から研究完了および安全性追跡調査まで、最大約24ヶ月間評価されます
|
|
疾患制御率 (DCR)
時間枠：期間: ベースライン時、および治療2サイクルごと（各サイクルは21日間）、疾患の進行、死亡、または研究からの撤退のいずれかが最初に発生するまで、最大約24ヶ月間評価
|
RECIST 1.1に基づき、全登録対象集団における完全奏効（CR）、部分奏効（PR）、または安定疾患（SD）を達成した被験者の割合
|
期間: ベースライン時、および治療2サイクルごと（各サイクルは21日間）、疾患の進行、死亡、または研究からの撤退のいずれかが最初に発生するまで、最大約24ヶ月間評価
|
|
progression free survival
時間枠：Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
Time from first treatment to disease progression or death from any cause, whichever occurs first
|
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
|
Quality of Life Score（QOL Score）
時間枠：At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment.
The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale.
Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100.
Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.
|
At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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