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

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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