NCT06498479招募中3 期
ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Hansoh BioMedical R&D Company9 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2024年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 460
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).
详细描述
This is a phase 3, randomized, open-label, multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen. Subjects will be randomized by a ratio of 1:1 to receive HS-20093 or topotecan until disease progression.
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of HS-20093. The exploratory objectives are to characterize the pharmacokinetics of HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression and soluble B7-H3 expression.
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
- •Male or female subjects ≥18 years of age.
- •Histologically or cytologically confirmed SCLC.
- •Subjects who progressed on or after first-line platinum-based regimens.
- •Has at least 1 measurable lesion as defined per RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Minimum life expectancy of more than 12 weeks.
- •Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- •Men or women should be using adequate contraceptive measures throughout the study.
- •Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
排除标准
- •Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
- •Chemotherapy-free interval ≤30 days.
- •Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
- •Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
- •Has inadequate washout period before randomization as specified in the protocol.
- •Untreated or symptomatic brain metastases with exceptions defined in the protocol.
- •Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
- •History of other malignancy with exceptions defined in the protocol.
- •Inadequate bone marrow reserve or organ dysfunction.
- •Evidence of cardiovascular risks.
- •Severe, uncontrolled or active cardiovascular diseases.
- •Severe or uncontrolled diabetes.
- •Severe or uncontrolled high blood pressure.
- •Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.
- •Severe arterial or venous thromboembolic events within 3 months prior to randomization.
- •Severe infections within 4 weeks before randomization.
- •Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.
- •The presence of active infectious diseases before randomization.
- •Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
- •History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.
- •History of severe neuropathy or mental disorders.
- •Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.
- •Vaccination or hypersensitivity of any level within 4 weeks before randomization.
- •History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
- •Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.
研究组 & 干预措施
HS-20093
Experimental
Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol.
干预措施: HS-20093 (Drug)
Topotecan
Active Comparator
Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol.
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall survival
时间窗: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years
Overall survival is defined as the time interval from randomization to death due to any cause.
次要结局
- Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.)
- Duration of Response Assessed by Blinded Independent Central Review and Investigator(From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.)
- Progression-free Survival Assessed by Blinded Independent Central Review and Investigator(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.)
- Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.)
- Incidence and Grade of Participants With Treatment-emergent Adverse Events(From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.)
研究者
研究点 (9)
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相关资讯
B7-H3 ADC Ris-Rez Cuts Death Risk 54% in Relapsed Small-Cell Lung Cancer- The Phase III ARTEMIS-008 trial showed risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small-cell lung cancer.
- Median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median follow-up of 12.2 months.
- Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, mostly hematologic toxicities.
- GSK, which holds ex-China rights to the B7-H3-directed antibody-drug conjugate, is advancing a global development program including the Phase III EMBOLD SCLC-301 trial.yesterdayRis-Rez Cuts Death Risk 54% Versus Topotecan in Relapsed SCLC, First Phase III OS Win for a B7-H3 ADC- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer.
- In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up.
- Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%.
- Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.4 days ago