NCT06185400

RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in 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 protein overexpression, using Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs, 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
• ERBB2 Gene Duplication
• Disitamab Vedotin

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC
DRUG	third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)	RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression
DRUG	pyrotinib	RC48+pyrotinib after EGFR-TKIs progression

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-07-01
• Completion: 2026-12-01
• First posted: 2023-12-29
• Last updated: 2023-12-29