Phase II Study of Tislelizumab With Chemotherapy and Thoracic Radiotherapy for First-Line Treatment of Extensive Stage Small Cell Lung Cancer

What this Trial Is About

The trial investigates the use of tislelizumab combined with chemotherapy followed by thoracic consolidation radiotherapy as a first-line treatment for patients newly diagnosed with extensive stage small cell lung cancer ES-SCLC. This prospective, single-arm phase II study aims to evaluate this treatment approach in 36 patients meeting specific inclusion criteria, focusing on tumor progression and survival outcomes. Participants will first receive induction therapy consisting of 4 to 6 cycles of tislelizumab combined with the EP chemotherapy regimen. Following this, an evaluation of treatment effectiveness will determine if patients have achieved remission. Those who do will then undergo consolidation chest radiotherapy alongside continued tislelizumab treatment. After completing consolidation therapy, patients will receive maintenance therapy with tislelizumab until disease progression, unacceptable side effects, or voluntary withdrawal, with treatment lasting up to 2 years. During the study, participants will undergo regular assessments including tumor evaluations based on RECIST version 1.1 criteria to monitor progression-free survival, response rates, disease control, remission duration, and overall survival for up to 24 months. Safety and tolerability will be monitored throughout treatment. The study requires participants to comply with scheduled visits and assessments to track treatment effects and disease status over time.

Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer