Durvalumab Plus Chemotherapy Shows Real-World Activity in Extensive-Stage SCLC
Key Clinical Takeaways
- Design/Population: This prospective, single-arm phase 3b study enrolled 101 real-world patients with extensive-stage SCLC and ECOG performance status 0 to 2, permitting up to 30% with performance status 2. Patients received up to 6 cycles of durvalumab plus platinum-etoposide followed by durvalumab maintenance every 4 weeks.
- Key Outcomes: Grade ≥3 adverse events occurred in 76.2% of patients, with more than half considered treatment related; immune-mediated adverse events were reported in 37.6% of patients and were largely grade 1 to 2. Median overall survival was 9.6 months, with 12-month and 24-month survival rates of 40.7% and 25.4%, respectively.
- Clinical Relevance: These real-world findings support the feasibility and clinical relevance of durvalumab plus platinum-etoposide as first-line therapy for extensive-stage SCLC across a broader patient population than traditional trial settings. The manageable safety profile and observed survival outcomes reinforce its role in routine clinical practice.
Results from the phase 3b CANTABRICO trial demonstrate that first-line durvalumab plus platinum-etoposide shows acceptable safety and clinically meaningful survival benefit among patients with extensive-stage small cell lung cancer (ES-SCLC).
“Immunotherapy trials involving patients with [ES-SCLC] from real-world clinical practice are needed,” stated Dolores Isla, MD, University Hospital Lozano Blesa, Zaragoza, Spain, and coauthors. Here, “we aimed to evaluate the safety and effectiveness of durvalumab plus platinum-etoposide as a first-line treatment in a real-world population of patients with ES-SCLC.”
In this prospective, single-arm study, 101 patients with histologically or cytologically confirmed ES-SCLC and ECOG performance status 0 to 2 received up to 6 cycles of durvalumab plus platinum–etoposide followed by durvalumab maintenance every 4 weeks. Up to 30% of enrolled patients were permitted to have a performance status of 2. The primary end point was safety, and the key secondary end point was overall survival (OS).
At analysis, grade ≥3 adverse events occurred in 76.2% of patients, 57.4% of which were considered treatment related. Treatment-related immune-mediated adverse events were reported in 37.6% of patients, and 82.9% of the 82 documented immune-mediated events were grade 1 or 2. Median OS was 9.6 months, with 12-month and 24-month OS rates of 40.7% and 25.4%, respectively.
As Dr Isla et al concluded, “this phase 3b trial suggests that first-line treatment of patients with ES-SCLC with an initial regimen of up to [6] cycles of durvalumab plus platinum-etoposide followed by maintenance with durvalumab is feasible providing more options in daily clinical practice for the management of these patients depending on their characteristics.”
Source:
Isla D, Zugazagoitia J, Arriola E, et al. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. Published online: September 24, 2025. doi:10.1016/j.lungcan.2025.108763
