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 genenegative non-small cell lung cancer；

4. At least one measurable target lesion assessed by the investigator according to therequirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesionsproposed for percutaneous PTS local injection；

5. Localized injectable lesions located in a more confined area of the outer lungbands, less than or equal to 5 cm in diameter; these may be primary lesions that arenot amenable to surgical resection or localized recurrent lesions after surgicalresection and radiotherapy treatment；

6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTSintratumoral injections；

7. Patients with localized lesions present and persistently stable (SD evaluated aftertwo courses of treatment) after standard treatment with first-linechemoimmunotherapy；

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 thestudy period;

8. The investigators determined that the patients had other conditions that made themunsuitable for enrollment.