Study of Safe Intrapleural Injection of TolueneSulfonamide for Patients With Malignant Pleural Effusion from Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying the safety and possible effectiveness of intrapleural injection of TolueneSulfonamide PTS in patients with malignant pleural effusion MPE, a condition often related to non-small cell lung cancer. This first-in-human study has two parts an initial safety and dose-exploration phase, followed by a randomized controlled trial to evaluate the treatments effectiveness. The study aims to better understand how PTS works in managing MPE and improving patient outcomes. In the first part, patients receive PTS through a catheter inserted in the pleural cavity, with treatments given three times a week for one week. Before each injection, fluid is drained from the pleural space, and after administration, patients change positions to help spread the drug evenly. In the second part, participants are randomly assigned to receive either PTS with catheter drainage or catheter drainage with a normal saline placebo, following the same treatment schedule. After treatment cycles, standard care and drainage continue. Participants will be closely monitored through clinical evaluations, symptom assessments, and imaging to measure changes in pleural effusion volume. Researchers will track the objective response rate at various time points up to 12 months after treatment. They will also assess survival, breathing difficulty scores, quality of life, and any significant side effects. The study duration includes treatment and follow-up periods lasting up to one year, allowing for thorough observation of treatment impact and safety.

First-in-Human Expanded Cohort Study of Intrapleural Administration of TolueneSulfonamide in Patients With Malignant Pleural Effusion