NCT07193160

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

A Multicenter, Single-arm, Phase II Clinical Study of 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Monotherapy with third-generation EGFR-TKIs has become the standard first-line treatment for advanced NSCLC with EGFR mutations. However, acquired resistance inevitably occurs. ADCs harness the precise targeting and selectivity of monoclonal antibodies while capitalizing on the potent cytotoxic effects of their payload, thereby minimizing off-target toxicity. Sacituzumab Tirumotecan (sac-TMT) is a novel TROP2-directed ADC, had shown encouraging antitumor efficacy in previously treated patients with EGFR mutated advanced NSCLC. Theoretically, combination with small molecule inhibitors (including EGFR-TKI) are one of the combinational strategies for TROP2-ADC with synergistic mechanism. This study aims to evaluate the efficacy and safety of furmonertinib plus Sacituzumab Tirumotecan in patients with EGFR mutated advanced NSCLC after failure of first-line third-generation EGFR-TKI therapy.

Conditions

• NSCLC (Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-07-01
• Completion: 2027-05-30
• First posted: 2025-09-25
• Last updated: 2025-09-25