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

NCT07703228 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-07-14

No results posted yet for this study

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

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • NSCLC Stage IIIB~IV
  • Second-line Therapy
  • Metastases

Interventions

DRUG

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.

DRUG

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

Sponsors & Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    collaborator OTHER

  • Shenzhen Hospital, Guangzhou University of Chinese Medicine

    collaborator UNKNOWN

  • The Central Hospital of Huanggang

    collaborator OTHER

  • Department of Obstetrics and Gynecology, Affiliated Dongguan People's Hospital, Southern Medical University

    collaborator UNKNOWN

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-13
Primary Completion
2027-09-30
Completion
2028-03-13

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703228 on ClinicalTrials.gov