ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат HS-20093
  HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.
• Препарат Topotecan
  Topotecan will be administered per drug label.

Первичные конечные точки

• Overall survival [Срок оценки: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.]

Критерии участия

Критерии включения

• 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 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Beijing Cancer Hospital — Пекин
• Harbin Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• Jilin Cancer Hospital — Changchun
• Shengjing Hospital of China Medical University — Шэньян
• Shandong Cancer Hospital — Цзинань
• Shanghai Pulmonary Hospital — Шанхай
• The First Affiliate Hospital of GUANGZHOU Medical University — Гуанчжоу
• … и ещё 1 центр

Идентификаторы

NCT: NCT06498479 · HS-20093-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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