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RECRUITING
NCT06109558
PHASE1/PHASE2

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

Sponsor: Hunan Province Tumor Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-12-31

Completion Date

2027-07-30

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

DRUG

LMV-12(HE003)

1 cycle was 28 days. LMV-12(HE003), 30mg or 60mg, continuously for 21 days, and the drug was discontinued for 7 days. Osimertinib, 80mg, continuously for 28 days.

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China