Clinical Trial

Second-Line Sacituzumab Tirumotecan Plus Anlotinib for Advanced Driver Gene-Negative Non-Squamous NSCLC

Active, Not Recruiting Phase 2
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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
Trial Details
NCT Number NCT07703228
Lead Sponsor Nanfang Hospital, Southern Medical University
Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Shenzhen Hospital, Guangzhou University of Chinese Medicine, The Central Hospital of Huanggang, Department of Obstetrics and Gynecology, Affiliated Dongguan People's Hospital, Southern Medical University
Conditions NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC Stage IIIB~IV, Second-line Therapy, Metastases
Enrollment 38 participants
Start Date 2025-08-13
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-14