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

Sponsor
Fudan University
Study ID
NCT07193160
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • NSCLC (Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
May 30, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sac-TMT + Furmonertinib

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]

Central Contacts

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