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The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC — PROFILE  

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Prospective Clinical Research of Efficacy and Safety of LMV-12(HE003) Combined With Osimertini in the Treatment of Advanced Non-small Cell Lung Cancer That Has Previously Failed From EGFR Inhibitor Therapy

Clinical Trial Summary

This is an open-label, single-arm, dose-escalation, multicenter phase I/II clinical trial. The primary endpoints of this study were to evaluated the safety, tolerability, pharmacokinetic profile and preliminary efficacy of HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The secondary endpoints of this study were to evaluated the efficacy HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy.

Clinical Trial Description

This is an open-label, single-arm, dose-escalation, multicenter phase I/II clinical trial. The primary endpoints of this study were to evaluated the safety, tolerability, pharmacokinetic profile and preliminary efficacy of HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The secondary endpoints of this study were to evaluated the efficacy HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The study were devided in several cohorts following the different subgroups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06109558
Study type Interventional
Source Hunan Province Tumor Hospital
Contact Yongchang C Zhang, MD
Phone +8613873123436
Email zhangyongchang@csu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date December 31, 2023
Completion date July 30, 2027
View Details
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