Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC

Официальное название

Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC: A Single Arm, Phase II Clinical Study

Обзор

This study aims to explore the efficacy and safety of radiotherapy combined with immunotherapy in the neoadjuvant treatment of resectable NSCLC.

Вмешательства

• Препарат Tislelizumab
  200mg, iv, Q3W, 3-4 cycle
• Лучевая терапия 3D-CRT/IMRT
  40Gy in 20 fractions

Первичные конечные точки

• pCR rate [Срок оценки: 18 months]

Вторичные конечные точки (2)

• MPR Rate [Срок оценки: 18 months]
• 1-year EFS Rate [Срок оценки: Baseline up to 1 years]

Критерии участия

Критерии включения

• Fully understand the study and voluntarily sign the informed consent form (ICF);
• Aged 18-70 years, regardless of gender;
• Previously untreated, histologically confirmed resectable stage IB-IIIA NSCLC (AJCC 9th edition staging);
• At least one measurable lesion per RECIST v1.1 criteria;
• Willing to provide PD-L1 immunohistochemistry slides and corresponding pathology reports for biomarker evaluation;
• Presence of lesions suitable for radiotherapy as assessed by the study team;
• ECOG performance status of 0-1;
• Adequate organ function;
• Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
• Sufficient pulmonary function to tolerate planned lung resection surgery, as assessed by a surgeon;
• Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Both female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.

Критерии исключения

• Presence of locally advanced unresectable or metastatic disease;
• NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
• Participants with known EGFR mutations or ALK translocations (non-squamous NSCLC subjects must have confirmed EGFR/ALK mutation status);
• Prior systemic anticancer therapy for early-stage NSCLC, including investigational drugs; Contraindications to radiotherapy or inability to undergo radiotherapy;
• History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease requiring steroid treatment;
• Known active tuberculosis (TB) history; Known active infection requiring systemic therapy; Any known or suspected autoimmune disease or immunodeficiency;
• Active hepatitis B infection; Administration of live vaccines within 30 days before the first dose;
• Grade ≥2 peripheral neuropathy;
• Prior treatment with PD-1/PD-L1 inhibitors or drugs targeting other T-cell receptors (e.g., CTLA-4, OX-40, etc.);
• History of severe hypersensitivity to monoclonal antibodies;
• Severe or uncontrolled underlying medical conditions;
• Any condition that, in the investigator's judgment, may confound study results, interfere with the subject's participation, or compromise the subject's best interest in the study.

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

• Jiangsu Northern People Hospital — Yangzhou

Идентификаторы

NCT: NCT07050056 · 2025ky220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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