NCT05509699

Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

An Open-Label, Multi-Center Phase II Study of Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC.

Detailed description

This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized, controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after prior platinum-based chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy and safety. Approximately 40 patients are planned to be enrolled in the randomized and controlled Phase IIb study with 20 patients per group.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.
DRUG	Anti-PD-1/L1	Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-08-22
• Last updated: 2025-08-29

Locations

1 site across 1 country: China