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Second-Line Sacituzumab Tirumotecan Plus Anlotinib for Advanced Driver Gene-Negative Non-Squamous NSCLC
Sponsor: Nanfang Hospital, Southern Medical University
Summary
The goal of this clinical trial is to evaluate whether sacituzumab govitecan (TROP2 antibody-drug conjugate) in combination with anlotinib (multi-target tyrosine kinase inhibitor) can improve treatment efficacy and safety in patients with driver gene-negative locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after failure of first-line immunotherapy combined with platinum-based chemotherapy. The main questions it aims to answer are: Can the combination of sacituzumab govitecan and anlotinib improve progression-free survival (PFS) compared to historical second-line chemotherapy outcomes? What is the objective response rate (ORR) and safety profile of this combination therapy in this patient population? Can baseline multi-omics biomarkers (metabolomics, proteomics, and ctDNA genomics) predict response or resistance to sacituzumab govitecan? If there is a comparison group: This is an exploratory single-arm study, and outcomes will be compared with historical controls of second-line chemotherapy in similar patient populations. Participants will: Receive sacituzumab govitecan combined with anlotinib according to the study treatment schedule Undergo routine imaging evaluations to assess tumor response Provide peripheral blood samples before treatment for metabolomic, proteomic, and ctDNA genomic analyses Be monitored regularly for treatment response and adverse events
Official title: A Multicenter Clinical Study Evaluating the Efficacy and Safety of Sacituzumab Tirumotecan Combined With Anlotinib as Second-Line Treatment for Patients With Driver Gene-Negative Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2025-08-13
Completion Date
2028-03-13
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
Sacituzumab Tirumotecan is administered via intravenous (IV) infusion at a dose of 4 mg/kg on Day 1 of each 14-day cycle (Q2W). The treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria are met.
Anlotinib
Anlotinib is administered orally (PO) at a dose of 10 mg once daily before breakfast on Days 1 through 14 of each 21-day cycle (Q3W). The treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-specified discontinuation criteria are met
Locations (1)
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China