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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
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.
Objective Response Rate (ORR)
Objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Time frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months.
Progression-Free Survival (PFS)
The time from the first dose of study treatment to the first documented disease progression or death from any cause.
Time frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months
Overall Survival (OS)
The time from randomization (or first dose) to death from any cause.
Time frame: From first dose until death, assessed every 6 weeks (Year 1) then every 12 weeks, and every 3 months during survival follow-up, up to approximately 24 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
30