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

NCT06109558 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-30

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer
  • RET Gene Mutation
  • MET Amplification
  • EGF-R Positive Non-Small Cell Lung Cancer

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.

Sponsors & Collaborators

  • Hunan Province Tumor Hospital

    lead OTHER

Principal Investigators

  • Nong Yang, MD · Hunan Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2026-12-30
Completion
2027-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109558 on ClinicalTrials.gov