Phase 12 Study Evaluating Quaratusugene Ozeplasmid with Atezolizumab as Maintenance Therapy for Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer ES-SCLC who have not experienced tumor progression after initial chemotherapy and immunotherapy. This study includes two phases Phase 1, which focused on selecting the appropriate dose, and Phase 2, which is assessing safety and effectiveness at the recommended dose. In Phase 1, patients received quaratusugene ozeplasmid intravenously every 21 days at varying doses alongside atezolizumab, also given intravenously every 21 days, until disease progression or unacceptable side effects occurred. Phase 2 continues treatment at the determined recommended dose of quaratusugene ozeplasmid combined with atezolizumab, with some patients also receiving hyaluronidase-tqjs subcutaneously every 21 days. Participants will be monitored through regular assessments including evaluation of side effects using standardized criteria, pharmacokinetic studies, and survival tracking. The main outcomes include identifying the appropriate dose and measuring progression-free survival over 18 weeks. Safety and overall survival will also be followed for months after treatment initiation, with treatment continuing until disease progression or unacceptable toxicity. Total participation duration varies based on individual treatment response and study phase.

Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients