The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.
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；
Age ≥18 years and ≤75 years at the time of signing the ICF；
Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
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；
Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
Have severe bleeding, clotting disorders, infections, dehydration, etc;
Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
Zhou Chengzhi
Lead sponsor
Guangzhou Institute of Respiratory Disease
Sponsor institution