MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC

Официальное название

Minimal Residual Disease (MRD)-Guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB Non-small Cell Lung Cancer (NSCLC): a Randomized Controlled Phase II Study (Seagull)

Обзор

Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC

Подробное описание

In the phase II trial, the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy will be compared with that of standard adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC.

Вмешательства

• Препарат adjuvant tislelizumab and chemotherapy for MRD+ patients
  MRD+ patients receive adjuvant tislelizumab and chemotherapy while MRD- patients just is recommended receive adjuvant chemotherapy untill be detected MRD+ adjuvant tislelizumab and chemotherapy (cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion)
• Препарат adjuvant tislelizumab and chemotherapy for MRD+ patients
  patients receive adjuvant tislelizumab and chemotherapy regardless of MRD status
• Препарат adjuvant chemotherapy for MRD- patients
  MRD- patients just be recommended receive adjuvant chemotherapy untill be detected cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion, limited to ≤4 cycles

Первичные конечные точки

• 2-year PFS rate [Срок оценки: up to 36 months after enrollment or study close]

Вторичные конечные точки (1)

• Percentage of patients changed from MRD+ to MRD- after treatment with tislelizumab for 6 months，12 months [Срок оценки: At the end of Cycle 8(each cycle is 21 days)、Cycle 16 (each cycle is 21 days)]

Критерии участия

Критерии включения

• Patient with age ≥ 18 years old, gender is not limited.
• Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.
• Receiving complete resection
• Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.
• ECOG score of 0 or 1.
• Females of childbearing age should take appropriate contraceptive measures from screening to 3 months after discontinuation of study treatment and should not breastfeed. The pregnancy test was negative before starting dosing.
• Male patients should use barrier contraception from screening to 3 months after discontinuation of study treatment.
• The subjects themselves participated voluntarily and signed the informed consent in writing.

Критерии исключения

• The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, other immunotherapy or systemic immune modulators (including but not limited to interferon, IL-2 and TNF etc).
• Histopathology with small cell or large cell endocrine tumor component.
• Harboring EGFR sensitizing mutation or ALK gene translocation
• History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for >5 years after the last treatment.
• At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy.
• Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, active bleeding, active infection including hepatitis B, C, HIV, etc., which the investigator considers unsuitable to participate in the study or affect the trial program compliance.
• History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease
• Insufficient bone marrow reserve or organ function.
• History of hypersensitivity reactions to any active or inactive ingredient of tislelizumab or to drugs that are chemically similar to tislelizumab or in the same class of tislelizumab.
• Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study.
• Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Zhengzhou University, — Чжэнчжоу

Идентификаторы

NCT: NCT05286957 · L2021-Y471

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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