NCT07388875

Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC

A Single-arm, Phase II Study of Sacituzumab Tirumotecan Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer After Failure of PD-(L)1 Inhibitor Plus Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Small cell lung cancer (SCLC) is an aggressive malignancy with a poor prognosis. While chemotherapy combined with immunotherapy is the standard first-line treatment for extensive-stage SCLC (ES-SCLC), therapeutic options remain limited for patients who progress after this initial therapy. There is an urgent need to explore new treatment strategies to extend patient survival. Sacituzumab Tirumotecan (SKB264) is a humanized antibody-drug conjugate (ADC) targeting TROP2, which is often overexpressed in SCLC. It works by delivering a topoisomerase I inhibitor directly to tumor cells. Anlotinib is a multi-target tyrosine kinase inhibitor that suppresses tumor angiogenesis and proliferation. This study investigates the potential synergistic effect of combining SKB264 with Anlotinib. The rationale is that anti-angiogenic therapy (Anlotinib) may normalize tumor vasculature, thereby enhancing the delivery and efficacy of the ADC (SKB264) within the tumor microenvironment. Eligible participants will receive Sacituzumab Tirumotecan (200 mg intravenously on Day 1 of each 3-week cycle) combined with Anlotinib (8 mg orally once daily on Days 1-14 of each 3-week cycle). The study utilizes a Simon's two-stage minimax design to assess the Objective Response Rate (ORR) as the primary endpoint. Secondary objectives include evaluating Progression-Free Survival (PFS), Overall Survival (OS), and the safety profile of the combination.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan	Sacituzumab tirumotecan is an antibody-drug conjugate targeting Trop-2. It will be administered intravenously according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
DRUG	Anlotinib	Anlotinib is an oral small-molecule multi-target tyrosine kinase inhibitor. It will be administered orally according to the dosing regimen specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2026-02-05
• Last updated: 2026-02-05