Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Официальное название

A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation

Обзор

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

Подробное описание

This is a single-arm, open, single-center, prospective and exploratory clinical study. We planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

Вмешательства

• Препарат Surufatinib
  250 mg, po, qd, q3w
• Препарат Tislelizumab
  200mg, iv, q3w

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: approximately 1 years]

Вторичные конечные точки (2)

• Objective response rate (ORR) [Срок оценки: approximately 1 years]
• Disease Control Rate (DCR) [Срок оценки: approximately 1 years]

Критерии участия

Критерии включения

• Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));
• Have at least one measurable lesion according to RECIST v1.1;
• ECOG performance status: 0-1;
• Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;
• Urine protein < ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;
• Expected survival time > 3 months;

Критерии исключения

• Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);
• Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
• Have uncontrolled hypertension, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
• Patients with active ulcer, intestinal perforation and intestinal obstruction;
• With active bleeding or bleeding tendency;
• Severe history of cardiovascular and cerebrovascular diseases;
• Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06414915 · HMPL-012-SPRING-NEN110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗