Phase 12 Study Evaluating Safety and Effectiveness of Intravenous Olvi-Vec with Platinum and Etoposide in Advanced Small Cell Lung Cancer Patients Who Have Relapsed After Platinum Treatment

What this Trial Is About

Researchers are evaluating Olvi-Vec, a genetically modified virus originally developed from acne virus, combined with platinum and etoposide chemotherapy in patients with advanced small cell lung cancer SCLC who have experienced disease progression or recurrence after platinum-based treatments. This open-label, phase 12 study aims to assess the safety, tolerability, and effectiveness of this combination in patients with late-stage SCLC who are platinum-refractory or platinum-recurrent. Olvi-Vec will be given intravenously for 3 consecutive days during the first treatment cycle. Starting from cycle 2, patients will receive platinum either cisplatin or carboplatin and etoposide on days 1, 2, and 3 every 21 days. Treatment will continue until disease progression or intolerable side effects. The study includes ongoing monitoring and evaluation during treatment cycles, following standard dosing according to drug labels. Participants will be monitored from enrollment until study completion or withdrawal, up to a maximum of 2 years. Researchers will evaluate safety from the first day through the end of the study. Other assessments include dose-limiting toxicities during the first treatment cycle, objective response rate, disease control rate, and progression-free survival over the study period. Safety and tolerability, as well as treatment responses, will be closely observed throughout the trial.

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC