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Идёт набор NCT04316364

A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

Фаза III С лечением Non-Small-Cell Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin, SHR-1316、Chemotherapeutic, Placebo、Chemotherapeutic.
Кому может быть актуально
Состояния в реестре: Non-Small-Cell Lung Cancer. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

Обзор

This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.

Вмешательства

  • Препарат SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
    Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
  • Препарат SHR-1316、Chemotherapeutic
    Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
  • Препарат Placebo、Chemotherapeutic
    Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert

Первичные конечные точки

  • Major pathological response rate (MPR) [Срок оценки: At time of surgery]
  • Event free survival (EFS) [Срок оценки: Approximately 66 months]
Вторичные конечные точки (4)
  • Overall survival (OS) [Срок оценки: Approximately 96 months]
  • Pathology complete response (pCR) [Срок оценки: At time of surgery]
  • Objective response rate (ORR) [Срок оценки: prior to surgery]
  • Disease-Free Survival (DFS) [Срок оценки: Approximately 66 months]

Критерии участия

Критерии включения

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
  • Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
  • Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
  • Measurable disease as defined by RECIST v1.1
  • Adequate organ function
  • Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment

Критерии исключения

  • Any previous systematic anti-cancer therapy for lung cancer
  • With active, known or suspected autoimmune disease of autoimmune disease
  • Malignancies other than NSCLC within 5 years prior to randomization
  • Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
  • Significant history of cardiovascular and cerebrovascular disease
  • Significant haemorrhagic disease
  • Has an arteriovenous thrombotic events
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known active Hepatitis B or Hepatitis C
  • Allergic to monoclonal antibodies or other protein drugs
  • Allergic to the intervention regimens
  • Pregnant or lactating women
  • Has known psychiatric or substance abuse disorders
  • Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 7 центров
  • Beijing Cancer Hospital — Пекин
  • Guangdong Provincial People's Hospital — Гуанчжоу
  • Henan Cancer Hospital — Чжэнчжоу
  • JiangSu Cancer Hospital — Нанкин
  • Zhongshan Hospital, Fudan University — Шанхай
  • West China Hospital,Sichuan University — Чэнду
  • ZheJiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT04316364 · SHR-1316-III-303

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗