drugset / Trial / NCT07388875

Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC

NCT07388875

Phase 2 Not yet recruiting 30 enrolled China Medical University, China
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). The study is designed for patients who have experienced disease progression or treatment failure after prior first-line therapy with a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. The primary hypothesis is that this combination therapy will improve the objective response rate compared to historical controls.

Timeline

Start
2026-02-24
Primary completion
2027-02-01
Completion
2027-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 8 mg Oral
Subject Sacituzumab Tirumotecan Other / unclassified 200 mg Intravenous