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
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate
기간: 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
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Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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부작용 (AE)
기간: 정보에 입각한 동의서 서명부터 연구 완료 및 안전성 추적 관찰까지, 최대 약 24개월 동안 평가
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모든 신규 또는 악화된 불리한 의학적 사건을 기록하고, CTCAE 5.0에 따라 등급을 매기고 발생률을 계산합니다.
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정보에 입각한 동의서 서명부터 연구 완료 및 안전성 추적 관찰까지, 최대 약 24개월 동안 평가
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질병 통제율 (DCR)
기간: 시간 범위: 기준선 및 2주기 치료 후마다(각 주기는 21일), 질병 진행, 사망 또는 연구 중단 중 먼저 발생하는 시점까지, 최대 약 24개월 동안 평가
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RECIST 1.1에 따르면, 총 등록 인구에서 CR, PR 또는 안정 질환(SD)을 달성한 피험자의 비율
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시간 범위: 기준선 및 2주기 치료 후마다(각 주기는 21일), 질병 진행, 사망 또는 연구 중단 중 먼저 발생하는 시점까지, 최대 약 24개월 동안 평가
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progression free survival
기간: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
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Time from first treatment to disease progression or death from any cause, whichever occurs first
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Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
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Quality of Life Score（QOL Score）
기간: At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
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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.
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At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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