Tests microwave ablation with two drugs in advanced lung cancer

Who can take part

• Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment
• Male or female patients aged ≥18 years who have provided written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator
• Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy
• Adequate organ and bone marrow function, defined as follows:; Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L White blood cell count ≥3.0 × 10⁹/L; Hepatic function:; Total bilirubin <1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and/or bone metastases: ALP ≤5.0 × ULN; Renal function:; Serum creatinine ≤1.5 × ULN Urine protein <2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required; Coagulation function:; International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN
• Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%
• Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements

Who cannot take part

• Concurrent participation in another interventional clinical trial for cancer treatment
• History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation
• Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period
• Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and/or history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode)
• Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer
• Known or suspected hypersensitivity to tislelizumab and/or any of its excipients
• Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study
• Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:; Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) >470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval >250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum/plasma potassium < LLN; magnesium < LLN; calcium < LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes
• Participants meeting any of the following criteria will be excluded from the study:
• Presence of symptomatic brain metastases at the start of treatment
• Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures)
• Pregnant or breastfeeding women
• Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment