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The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06109558•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.

Detailed Description

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligible subjects selected for this study must meet all of the following criteria:
•1. Sign written informed consent before implementing any trial-related procedures;
•2. Age ≥18 years old;
•3. No limit on the gender;
•4. Histological or cytological confirmed advanced or metastatic non-small cell lung cancer, ineligible for radical surgery, relapse after failure of previous treatment with first-line (including first, second, and third generation)EGFR inhibitors.
•Cohort A：MET amplification,(by FISH, NGS or IHC) Cohort B：RET fusion.
•5. Laboratory tests for organ function levels must meet the following requirements:
•1. Absolute neutrophil count ≥ 1.5 × 109/L;
•2. Platelet count ≥ 100 × 109/L;
•3. Hemoglobin ≥ 9 g/dL;
+3 more criteria

Exclusion Criteria

•1. Subjects treated with CYP isozyme inducers or inhibitors (see Appendix 4 for details) within 3 weeks prior to enrollment;
•2. Pregnant or lactating women;
•3. History of immunodeficiency or other acquired, congenital immunodeficiency diseases;
•4. Patients with prior bone marrow transplantation or prior solid organ transplantation;
•5. Patients with a combination of gastrointestinal perforation, gastrointestinal fistula, or non-gastrointestinal fistula;
•6. Prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
•7. Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV-positive). Hepatitis B is eligible for this study at \<500 IU/mL (or 2500 cps/mL) by quantitative HBV-DNA testing, and hepatitis C (HCV) antibody-positive patients are eligible for this study only if the polymerase chain reaction shows HCV RNA negativity;
•8. Fulfillment of any of the following cardiac criteria: (i) Bazetts' mean corrected QT interval (QTc) derived from electrocardiogram (ECG) examination at rest \>470 msec (women) or \>450 msec (men) (in the case of the 1st abnormality, retested once within 48 h and calculated by averaging the results of the 2 times); and (ii) a wide variety of clinically significant rhythmic, conduction, and resting ECG morphologic Abnormalities, such as complete left bundle branch block, grade III conduction block, grade II conduction block, PR interval \>250 msec; (iii) Myocardial ischemia or myocardial infarction of grade I or higher, or congestive heart failure of grade ≥2 (New York Heart Association (NYHA) classification); (iv) Factors that may increase the risk of prolongation of QTc or the risk of arrhythmic events, such as coronary artery disease, heart failure hypokalemia, congenital long QT syndrome, family history of a first-degree relative with long QT syndrome or sudden unexplained death before the age of 40, and ongoing use of any medication known to prolong the QT interval;

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Key Dates

Start Date

December 31, 2023

Primary Completion Date

December 30, 2026

Completion Date

July 30, 2027

Last Updated

May 30, 2024

Enrollment

120

ESTIMATED participants

Conditions

Non Small Cell Lung CancerRET Gene MutationMET AmplificationEGF-R Positive Non-Small Cell Lung Cancer

Interventions

LMV-12(HE003)

DRUG

Contacts

Yongchang C Zhang, MD

CONTACT

+8613873123436 zhangyongchang@csu.edu.cn

Nong C Yang, MD

CONTACT

+8613873123436 yangnong0217@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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