Oral Paclitaxel as Neoadjuvant Therapy in Elderly NSCLC: A Phase II Trial

Официальное название

A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer

Обзор

This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.

Вмешательства

• Препарат Paclitaxel Oral Solution
  Oral Paclitaxel Solution: 200 mg/m² administered on a 21-day cycle, with oral doses given on Day 1 and Day 8 of each cycle, taken twice daily (morning and evening). Immunotherapy: Anti-PD-1 or anti-PD-L1 monoclonal antibodies will be administered in combination. The specific agent will be selected by the investigator in accordance with the Standard of Care (SOC), and the dosing regimen will be implemented in line with the drug's official prescribing information.

Первичные конечные точки

• Pathological Complete Response (pCR) [Срок оценки: up to 30 months]

Вторичные конечные точки (1)

• Adverse Reaction Incidence Rate [Срок оценки: up to 30 months]

Критерии участия

Eligibility Criteria

Критерии включения

• Age 70-85 years, any gender
• ECOG performance status 0-1
• Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC)
• No distant metastasis, deemed resectable with curative intent
• Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology
• Adequate function of major organs, defined as:
• Bone marrow: ANC ≥1.5×10⁹/L, platelet ≥100×10⁹/L, hemoglobin ≥9 g/dL
• Liver function: total bilirubin ≤1.5×ULN; ALT, AST ≤2.5×ULN
• Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; urine protein < +; if +, 24-h urine protein < 500 mg
• Normal blood glucose or well-controlled diabetes
• Pulmonary function: baseline FEV1 ≥2 L; if FEV1 < 2 L, postoperative predicted FEV1 > 800 mL confirmed by surgical evaluation
• Cardiac function: no myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency within the past 1 year
• Patients and families are fully informed and voluntarily provide written informed consent

Критерии исключения

• Previous lobectomy, radiotherapy, or systemic antitumor therapy
• Synchronous other malignancy with <5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)
• History of active autoimmune disease or requirement for systemic immunosuppressive therapy
• Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B/C with active replication, or syphilis
• Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment
• Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease
• Uncontrolled massive pleural effusion or pericardial effusion
• Major surgery, severe trauma, or other investigational drug therapy within 4 weeks
• Recent vaccination with antitumor vaccines or live vaccines
• Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07599163 · Lungmate-046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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