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Набор скоро начнётся NCT06591910

Induction Therapy With Serplulimab Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer

— Наблюдательное Unresectable Stage III 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: Chemoimmunotherapy, Surgery, Radiation.
Кому может быть актуально
Состояния в реестре: Unresectable Stage III Non-small-cell Lung Cancer. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

Induction Therapy With Serplulimab Combined With Chemotherapy Followed by Local Therapy for Unresectable Stage III Non-small Cell Lung Cancer

Обзор

For unresectable stage III (8th TNM) non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether induction chemoimmunotherapy followed by surgery or radiotherapy can provide good survival for this population. This prospective observational study aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery/radiotherapy.

Вмешательства

  • Препарат Chemoimmunotherapy
    Induction Serplulimab combined with chemotherapy
  • Процедура Surgery
    After induction chemoimmunotherapy, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
  • Лучевая терапия Radiation
    After induction chemoimmunotherapy, patients with tumors still unresectable will receive radiotherapy or other therapy.

Первичные конечные точки

  • Event-free survival (EFS) [Срок оценки: Up to 60 months]
Вторичные конечные точки (7)
  • Objective response rate (ORR) [Срок оценки: Up to 6 months]
  • Major pathologic response (MPR) [Срок оценки: Up to 6 months]
  • Disease-free survival (DFS) [Срок оценки: up to 60 months]
  • Overall survival (OS) [Срок оценки: up to 60 months]
  • R0 rate [Срок оценки: Up to 6 months]
  • Severe adverse event (SAE) rate [Срок оценки: up to 6 months]
  • Health related quality of life (HRQol) [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

  • The patient shall sign the Informed Consent Form.
  • Aged 18 ≥ years.
  • Histological or cytological diagnosis of unresectable NSCLC by needle biopsy, and stage III (8th TNM) confirmed by imageological examinations (CT, PET-CT or EBUS).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  • Life expectancy is at least 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1.
  • Patients with good function of other main organs (liver, kidney, blood system, etc.)
  • Patients with normal lung function can tolerate surgery;
  • Without systematic metastasis (including M1a, M1b and M1c);
  • Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  • Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).

Критерии исключения

  • Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
  • Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
  • With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  • Participants who are allergic to the test drug or any auxiliary materials;
  • Participants with Interstitial lung disease currently;
  • Participants with active hepatitis B, hepatitis C or HIV;
  • Pregnant or lactating women;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
  • Participated in another therapeutic clinical study;
  • Other factors that researchers think it is not suitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06591910 · LungMate-Unresectable

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗