ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 406
- 主要终点
- Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.
详细描述
This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after receiving chemoradiotherapy (CRT).
This study consists of an experimental arm and a control arm. The experimental arm will be administered HS-20093, and the control arm will only receive active surveillance. Efficacy and safety were assessed in both arms by follow-up analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed Informed Consent Form.
- •Males or females ≥18 years old.
- •Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.
- •ECOG performance status of 0-
- •Patients who have received CRT and have not progressed.
- •Minimum life expectancy > 12 weeks.
- •Males or Females should be using adequate contraceptive measures throughout the study.
- •Females must not be pregnant at screening or have evidence of non-childbearing potential.
排除标准
- •Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
- •Patients with extensive-stage SCLC.
- •Disease progression during CRT or before randomization.
- •Received or are receiving the following treatments:
- •For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide
- •Received any other anti-cancer treatment.
- •Previous or current treatment with B7-H3 target therapy.
- •Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.
- •Major surgery within 4 weeks prior to the first dose of study drug.
- •Interstitial lung disease (ILD)/non-infectious pneumonitis.
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ functions.
- •Severe, uncontrolled or active cardiovascular disorders.
- •Severe or uncontrolled diabetes.
- •Serious or poorly controlled hypertension.
- •Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.
- •Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
- •Serious infection within 4 weeks prior to randomization.
- •Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- •Having serious neurological or mental disorders.
- •History of hypersensitivity to any component of HS-200093 or its similar drugs.
- •Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
研究组 & 干预措施
HS-20093
Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will be administrated HS-20093 intravenously at a dose of 8.0 mg/kg, Q3W continuously until disease progression or until other criteria for discontinuation of treatment are met.
干预措施: HS-20093 (Drug)
结局指标
主要结局
Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)
时间窗: Approximately 6 years
To assess the efficacy of HS-20093 vs active surveillance in terms of PFS. PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1.
Overall survival (OS)
时间窗: Approximately 6 years
To assess the efficacy of HS-20093 vs active surveillance in terms of OS. Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
次要结局
- DCR According to RECIST v1.1 by IRC(From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.)
- PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC(Approximately 6 years.)
- ORR According to RECIST v1.1 by IRC(From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.)
- DoR by IRC(From the date of CR, PR until the date of disease progression or death, approximately 6 years.)
- PFS According to RECIST v1.1 by investigators (INVs)(Approximately 6 years.)
- PFS12 or PFS18 According to RECIST v1.1 by INVs(Approximately 6 years.)
- ORR According to RECIST v1.1 by INVs(From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.)
- DCR According to RECIST v1.1 by INVs(From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.)
- DoR According to RECIST v1.1 by INVs(From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 6 years.)
- Proportion of patients alive at 24 months (OS24) or 36 months (OS36)(Approximately 6 years.)
- Incidence and severity of treatment-emergent adverse events(From the date of first dose until 90 days after the final dose. A cycle is 21 days.)