A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）

Официальное название

A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.

Вмешательства

• Препарат SCTB41
  SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle
• Препарат docetaxel
  docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

Первичные конечные точки

• Frequency of adverse events (AEs) [Срок оценки: 24 months]

Вторичные конечные точки (4)

• Objective response rate (ORR) [Срок оценки: Up to 2 years]
• Disease control rate (DCR) [Срок оценки: Up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Overall survival (OS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form (ICF);
• ECOG 0-1;
• Survival duration more than 3 months;
• Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;
• Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC;
• At least one measurable non-brain lesion according to RECIST v1.1;
• Adequate major organ function.

Критерии исключения

• Histologically or cytologically confirmed presence of small cell carcinoma components;
• Prior treatment with docetaxel;
• Symptomatic central nervous system (CNS) metastases;
• Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
• Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;
• History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;
• Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;
• Bleeding tendency, high risk of bleeding, or coagulation disorders;
• Diagnosis of another malignancy;
• Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;
• Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;
• Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;
• Pregnant or breastfeeding women;
• Any other condition that the investigator considers inappropriate for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & T — Ухань

Идентификаторы

NCT: NCT07609251 · SCTB41-A302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗