Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer

The phase III ASTRUM-005 study (NCT04063163) has demonstrated promising antitumor efficacy and well tolerability of first-line serplulimab combined with chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). However, due to the strict eligibility criteria of randomized controlled trials (RCTs), real-world data on patients with more complex and varied conditions are currently lacking. This highlights the urgent need for real-world evidence to better understand the practical effectiveness and safety of treatments. ASTRUM-005R is a multicenter real-world study conducted in China, designed to evaluate the efficacy and safety of the first-line treatment serplulimab-based immunochemotherapy for ES-SCLC in real-world clinical practice. Additionally, it aims to compare its findings with the data of the randomized controlled phase III ASTRUM-005 trial (descriptive), providing insights into optimal treatment strategies for this patient population.

NCT Number	NCT06748495
Lead Sponsor	Hunan Cancer Hospital
Conditions	Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Enrollment	600 participants
Start Date	2024-02-05
Primary Completion	2024-12-30 (estimated)
Study Completion	2025-06-06 (estimated)
Updated on ClinicalTrials.gov	2025-02-27