NCT05847764

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.

Detailed description

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Conditions

• Non Small Cell Lung Cancer
• ERBB2 Mutation-Related Tumors
• RC48
• Disitamab Vedotin

Interventions

Type	Name	Description
DRUG	RC48+Tislelizumab+carboplatin	RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations
DRUG	RC48+Furmonertinib, 1L	RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations
DRUG	RC48+Furmonertinib, 2L+	RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-10-01
• Completion: 2025-05-01
• First posted: 2023-05-08
• Last updated: 2023-05-08

Locations

1 site across 1 country: China