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Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

NCT07193160 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-09-25

No results posted yet for this study

Summary

This study is a multicenter, single-arm, phase II clincial trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (sac-TMT) and Furmonertinib in the treatment of EGFR-mutant advanced or metastatic NSCLC after failure of first-line Third-generation EGFR-TKI therapy.

Conditions

  • NSCLC (Non-small Cell Lung Cancer)

Interventions

DRUG

Sacituzumab Tirumotecan

fixed dosage 4mg/kg iv, D1, D15, each 4 weeks one cycle. Drug reduction will be implemented according to the research plan.

DRUG

Furmonertinib

160mg QD or 80mg QD, each 4 weeks one cycle, according to the safety run-in phase, until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terrminate treatment, or other treatment termination criteria specified in the protocol. Drug reduction will be implemented according to the research plan.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

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
2025-11-01
Primary Completion
2026-07-01
Completion
2027-05-30

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Drugs

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 NCT07193160 on ClinicalTrials.gov