Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy

Inclusion Criteria: 1. Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures； 2. Age ≥18 years and ≤75 years at the time of signing the ICF； 3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer； 4. At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection； 5. Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment； 6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections； 7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy； 8. Life expectancy ≥ 3 months； 9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators. Exclusion Criteria: 1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection; 2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc; 3. Have severe bleeding, clotting disorders, infections, dehydration, etc; 4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc; 5. History of severe emphysema and pulmonary alveoli; 6. History of drug allergy or contraindication to toluene sulfonamide; 7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.