RecruitingPhase 1Phase 2NCT06109558

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

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


Sponsor

Hunan Province Tumor Hospital

Enrollment

120 participants

Start Date

Dec 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination therapy — LMV-12 plus osimertinib — in patients with advanced non-small cell lung cancer (NSCLC) whose tumors have specific genetic changes (MET amplification or RET fusion) and whose disease progressed after prior EGFR-targeting drugs. **You may be eligible if...** - You are 18 or older with advanced or metastatic NSCLC - Your cancer has a MET amplification or RET fusion (confirmed by testing) - Your cancer has stopped responding to first-, second-, or third-generation EGFR inhibitors - Your blood counts and organ function are within acceptable ranges - You are not pregnant or breastfeeding and agree to use contraception **You may NOT be eligible if...** - You have received recent medications that strongly interfere with the study drugs (CYP inhibitors/inducers) - You have had an organ transplant or bone marrow transplant - You have prior interstitial lung disease or radiation pneumonitis - You have active or significant hepatitis B, hepatitis C, or HIV - You have significant heart problems (severe arrhythmia, recent heart attack, heart failure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLMV-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

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NCT06109558


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