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Идёт набор NCT06241807

Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC

Фаза II С лечением IMMUNOTHERAPY Neoadjuvant Therapy Resectable Lung Non-Small Cell Carcinoma Biomarkers / Blood

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: Camrelizumab Plus Chemotherapy.
Кому может быть актуально
Состояния в реестре: IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma, Biomarkers / Blood. Базовые параметры: 18 лет — 75 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 Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer

Обзор

This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.

Вмешательства

  • Препарат Camrelizumab Plus Chemotherapy
    Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum \[cisplatin, 75 mg/m2; carboplatin, area under the curve, 5\])

Первичные конечные точки

  • Major Pathological Response Rate [Срок оценки: From date of surgery to 14 days later]
  • Pathologic complete response rate [Срок оценки: From date of surgery to 14 days later]
Вторичные конечные точки (2)
  • Adverse events [Срок оценки: 24 weeks]
  • Disease-free survival [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • Age 18-75
  • Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
  • Absence of EGFR, ALK, and ROS1 gene mutations
  • Eastern Cooperative Oncology Group (ECOG) status 0-1
  • Signed written informed consent prior to the implementation of any trial-related rocedures
  • Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \> 5 x ULN, Bilirubin \> 1.5 х ULN

Критерии исключения

  • Patients diagnosed with any other malignant tumor
  • Have received prior therapy with chemotherapy or immune checkpoint inhibitor
  • Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
  • Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
  • Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
  • A history of interstitial lung disease or non-infectious pneumonia
  • Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
  • Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
  • Patients who have received allogeneic stem cell or solid organ transplantation
  • Women during pregnancy or lactation

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
  • Shandong Cancer Hospital and Institute — Цзинань

Публикации

  • Cai G, Song P, Wang Z, Zhao J, Wang K, Li M, Wang X, Zhu J, Xu J, Huang B, Han X, Zhou H, Xie C, Fu S, Jia H, Teng F, Wang S, Sun H, Li W, Yu J, Meng X. Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. J Immunother Cancer. 2026 Jun 19;14(6):e015604. doi: 10.1136/jitc-2026-01560 PMID 42320986
  • Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10. PMID 40348946

Идентификаторы

NCT: NCT06241807 · SDZL-MX-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗