Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

Официальное название

A Prospective Phase II Study to Explore the Efficacy and Safety of Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant Treatment, Followed by Adjuvant Tislelizumab Therapy in Resectable Stage II-IIIB Non-small Cell Lung Cancer

Обзор

This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.

Вмешательства

• Препарат Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy
  Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles. The following platinum-based doublet chemotherapy regimens are allowed in this trial: * Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC) * Cisplatin/carboplatin +
• Процедура Surgery
  After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.
• Препарат Adjuvant tislelizumab
  Patients receiving adjuvant therapy must meet the following criteria: * ECOG performance status score of 0 or 1 * Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant

Первичные конечные точки

• Pathological Complete Response (pCR) Rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]

Вторичные конечные точки (7)

• Overall Response Rate (ORR) [Срок оценки: Up to Study Week 15 (before surgery)]
• Radiological downstaging rate [Срок оценки: Up to Study Week 15 (before surgery)]
• Major Pathological Response (mPR) Rate [Срок оценки: Up to approximately 8 weeks following completion of neoadjuvant treatment]
• Event Free Survival (EFS) [Срок оценки: Up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years]
• Number of participants experiencing treatment-emergent adverse events (TEAEs) [Срок оценки: Up to approximately 2 years]
• Change From Baseline in Neoadjuvant and Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Baseline, during the neoadjuvant phase (Cycle 3), during the adjuvant phase (Cycles 1, 3, 5, and 7), and during safety follow-up visits (up to 2 years)]

Критерии участия

Критерии включения

• Aged ≥18 years at informed consent signing.
• ECOG performance status of 0 or 1.
• Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
• Tumor size ≤5 cm.
• Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
• Adequate cardiopulmonary function for radical surgical resection.
• Eligible for cryoablation and platinum-based doublet chemotherapy.
• Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.

Критерии исключения

• Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
• LCNEC diagnosis.
• Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.

For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.

• Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
• History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
• Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
• Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
• Active autoimmune disease or history of recurrent autoimmune disease.
• Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
• Severe infections requiring systemic treatment within the past 4 weeks.
• Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.

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

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06939127 · CONCEPT study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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