PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC

Официальное название

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study

Обзор

This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.

Вмешательства

• Препарат Tislelizumab
  administered via Intravenous (IV) injection
• Препарат Carboplatin injection
  administered via IV injection
• Препарат Cisplatin injection
  administered via IV injection
• Препарат Etoposide injection
  administered via IV injection

Первичные конечные точки

• Pathologic Complete Response (pCR) Rate [Срок оценки: Up to 3 months following completion of neoadjuvant treatment]

Вторичные конечные точки (5)

• Major Pathologic Response (MPR) Rate [Срок оценки: Up to 3 months following completion of neoadjuvant treatment]
• Event-Free Survival (EFS) [Срок оценки: up to 5 years]
• Overall Survival (OS) [Срок оценки: up to 5 years]
• Objective response rate (ORR) [Срок оценки: Up to 1 months following completion of neoadjuvant treatment]
• Safety: frequency of severe adverse events [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
• They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
• The age range was 18 to 75 years, with no gender restriction.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
• Life expectancy was estimated to be at least 3 months.
• No previous anti-tumor treatment specifically for SCLC was administered.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.
• Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:

• Hematological parameters: ANC ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L.
• Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine clearance ≥50 mL/min.
• Liver function: ALT/AST ≤2.5 times the upper limit, total serum bilirubin ≤2 times the upper limit.
• Coagulation: INR should be ≤ 1.5 times the upper limit.
• Patients of childbearing potential must agree to use contraception.
• Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.

Критерии исключения

• Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
• Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
• Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
• Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
• Patients known to have HIV.
• Patients with active hepatitis B or hepatitis C.
• Patients with active autoimmune diseases or a history of autoimmune diseases that may recur.
• Patients with diseases requiring systemic corticosteroid treatment or other immunosuppressive therapy.
• Patients deemed by the investigator to have concomitant diseases that pose a serious risk to patient safety or could affect the patient's ability to complete the study.
• Patients who have undergone major surgery within 4 weeks prior to treatment initiation, or those with significant trauma or fractures, or those with unhealed wounds at the time of treatment.
• Patients with severe cardiac diseases, such as NYHA class III or higher congestive heart failure, CCS class III or higher angina, a history of myocardial infarction in the past 6 months, or arrhythmias requiring medication.
• Patients with comorbidities that make them unsuitable for surgery.
• Patients who have had an allergic reaction to the study drug or excipients in the medication.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06375109 · BJXK-2023-KY-53 · NeoSCLC-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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