Injection of toluenesulfonamide for advanced lung cancer treatment

A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer

This study is testing if injections of a new treatment called toluenesulfonamide can help people with advanced lung cancer feel better and live longer, either on its own or alongside standard chemotherapy and immunotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Institute of Respiratory Disease (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06607796 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of intratumoral injections of toluenesulfonamide (PTS) in patients with stage IV driver gene-negative non-small cell lung cancer (NSCLC). Participants may receive PTS alone or in combination with first-line chemoimmunotherapy. The study aims to determine how well this treatment works and its safety profile compared to standard treatments. Patients will be monitored for measurable target lesions and overall health status throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed stage IV driver gene-negative NSCLC and specific measurable lesions suitable for injection.

Not a fit: Patients with stage IV lung cancer that does not meet the inclusion criteria or those with lesions not suitable for intratumoral injection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who currently have limited treatment choices.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel intervention.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Chengzhi Zhou, doctor — The First Affiliated Hospital of Guangzhou Medical University,Guangzhou
• Study coordinator: Chengzhi Zhou, doctor

Conditions: Lung Cancer