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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Histologically/cytologically confirmed small cell lung cancer with staging that confirming disease stage as extensive (according to the modified American Veterans Administration Lung Cancer Society \[VALG\] staging system);
2. No prior systemic therapy for the diagnosis of ES-SCLC;
3. Patients previously treated with chemoradiation for limited-stage SCLC: must be treatment with curative intent and have a treatment-free interval of at least 6 months between the last dose of chemotherapy/last course, end of thoracic radiotherapy or chemoradiation and confirmation of ES-SCLC;
4. At least two cycles of treatment with Serplulimab in combination with chemotherapy with one or more documented efficacy assessments ;
5. Local radiotherapy is allowed for patients indicated for radiotherapy, including but not limited to thoracic radiotherapy, brain radiotherapy.

Exclusion Criteria:

1. Incomplete clinical information, such as no disease course, pathological diagnosis, treatment and observation of outcome data;
2. Patients with SCLC and other malignancies.

• DERIVEDWu L, Hu C, Su W, Zhu H, Hong W, Su H, Yu Y, Luo T, Liu Z, Liu Z, Pu Q, Wang C, Min X, Guo H, Chen Y. Real-world serplulimab plus chemotherapy for extensive-stage small cell lung cancer in china: an external validation of ASTRUM-005 trial. BMC Med. 2026 Jul 15. doi: 10.1186/s12916-026-05055-9. Online ahead of print. PMID 42458439