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Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases

NCT07343479 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-15

No results posted yet for this study

Summary

This is a prospective, open-label, multi-center, single-arm clinical trial

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • EGFR Gene Mutations
  • Brain Metastasis

Interventions

DRUG

sac-TMT plus EGFR-TKI

Eligible subjects will receive sac-TMT (4 mg/kg, twice weekly (Q2W)) + third-generation EGFR-TKI ± intracranial radiotherapy. The decision to initiate intracranial radiotherapy will be determined by the investigator based on the patient's clinical condition.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Yun Fan, Doctor · Zhejiang Cancer Hospital

  • Hui Li, Doctor · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-06-20
Completion
2029-12-20

Countries

  • China

Study Locations

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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 NCT07343479 on ClinicalTrials.gov