NCT07501169

Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.

Detailed description

Extensive-stage small cell lung cancer (ES-SCLC) is among the most aggressive lung cancer subtypes, with rapid progression and poor prognosis. Despite first-line immunotherapy plus chemotherapy improving outcomes, most patients relapse within one year and face limited options. Topotecan, the standard second-line therapy, yields only 10-20% ORR and median PFS of \~3 months. Therefore, identifying novel therapeutic strategies with improved efficacy in ES-SCLC represent an urgent unmet medical need. Sacituzumab tirumotecan, a structurally optimized Trop-2-directed ADC, and anlotinib, a multi-target TKI inhibiting VEGFR, FGFR, and MET, offer complementary mechanisms of action. We hypothesize that their combination may synergistically overcome acquired resistance to chemotherapy and immunotherapy, providing a novel therapeutic strategy for previously treated ES-SCLC. Eligible participants will receive Sacituzumab Tirumotecan (4mg/Kg intravenously on Day 1, Q2W) plus Anlotinib (8 mg orally once daily on Days 1-14, Q3W). The primary objective is Objective Response Rate (ORR), and the secondary objectives including but not limited Progression-Free Survival (PFS), Overall Survival (OS) and Disease control response (DCR) .

Conditions

• Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan and Anlotinib	Treatment with Sacituzumab Tirumotecan (4mg/kg IV d1 Q2W) and Anlotinib (8mg po d1-14 Q3W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient). Drug reduction or dose regulation will be implemented according to the research plan.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-31
• Completion: 2028-12-31
• First posted: 2026-03-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: China