A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат HS-20093
  Subjects in experimental arm will be given HS-20093 intravenously at a dose of 8.0 mg/kg every 3 weeks, until disease progression or until other criteria for treatment discontinuation are met.

Первичные конечные точки

• Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC) [Срок оценки: Approximately 6 years]
• Overall survival (OS) [Срок оценки: Approximately 6 years]

Вторичные конечные точки (11)

• PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC [Срок оценки: Approximately 6 years.]
• ORR According to RECIST v1.1 by IRC [Срок оценки: From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.]
• DCR According to RECIST v1.1 by IRC [Срок оценки: From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.]
• DoR by IRC [Срок оценки: 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) [Срок оценки: Approximately 6 years.]
• PFS12 or PFS18 According to RECIST v1.1 by INVs [Срок оценки: Approximately 6 years.]
• ORR According to RECIST v1.1 by INVs [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Approximately 6 years.]
• Incidence and severity of treatment-emergent adverse events [Срок оценки: From the date of first dose until 90 days after the final dose. A cycle is 21 days.]

Критерии участия

Критерии включения

• 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 0-1.
• 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.

Критерии исключения

• 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.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06526624 · HS-20093-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗