Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC

Korábbi kezelés

• Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy.
• Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment.
• Recent receipt of an anticancer vaccine or live vaccine.

Más betegség

• Another concurrent malignancy or a history of another malignancy cured less than 5 years before enrollment, except adequately treated cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin.
• Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment.
• Active infection requiring systemic treatment, active tuberculosis, human immunodeficiency virus infection, active hepatitis B or hepatitis C, active syphilis, or another active transmissible infection specified by the protocol.
• Severe cardiac, hepatic, renal, or metabolic disease that precludes surgery or study treatment.
• History of interstitial lung disease or drug-induced pneumonitis, or imaging evidence of active interstitial lung disease.
• Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study or may interfere with interpretation of the study results.

Egyéb

• Uncontrolled large pleural effusion or pericardial effusion.

• Age 70 years or older, regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed non-small cell lung cancer, clinical stage IIA-IIIB according to the 8th edition of the AJCC staging system.
• No evidence of distant metastasis and considered suitable for radical lung cancer surgery.
• The primary lung lesion is suitable for stereotactic body radiotherapy.
• No sensitizing driver alterations in EGFR, ALK, ROS1, or other tested actionable genes.
• Adequate major organ function, including all of the following:
• Absolute neutrophil count at least 1.5 × 10\^9/L, platelet count at least 100 × 10\^9/L, and hemoglobin at least 9 g/dL.
• Total bilirubin no more than 1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase no more than 2.5 × the upper limit of normal.
• Serum creatinine no more than 1.5 × the upper limit of normal or creatinine clearance at least 60 mL/min.
• Urine protein less than 1+; if urine protein is 1+, 24-hour urine protein must be less than 500 mg.
• Blood glucose within the normal range or stable glycemic control in participants with diabetes.
• Baseline forced expiratory volume in 1 second (FEV1) at least 2 L; if FEV1 is less than 2 L, the predicted postoperative FEV1 must be greater than 800 mL as assessed by a thoracic surgeon.
• No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency.
• The participant has been fully informed and voluntarily provides written informed consent.