Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06109558

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

Led by Hunan Province Tumor Hospital · Updated on 2024-05-30

120

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any trial procedures
  • Age 18 years or older
  • Any gender
  • Histological or cytological confirmation of advanced or metastatic non-small cell lung cancer not suitable for surgery
  • Relapse after failure of previous first-line (including first, second, and third generation) EGFR inhibitor treatments
  • MET amplification or RET fusion as determined by FISH, NGS, or IHC
  • Laboratory tests showing absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (or ≤ 5 times ULN if liver metastases present)
  • Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
  • For premenopausal women, negative pregnancy test within 7 days before treatment start and non-lactating
  • Use of adequate barrier contraception during treatment and for 3 months after completion
Not Eligible

You will not qualify if you...

  • Use of CYP isozyme inducers or inhibitors within 3 weeks before enrollment
  • Pregnant or breastfeeding women
  • History of immunodeficiency or acquired/congenital immunodeficiency diseases
  • Prior bone marrow or solid organ transplantation
  • Presence of gastrointestinal perforation, gastrointestinal fistula, or non-gastrointestinal fistula
  • Prior history or evidence of clinically active interstitial lung disease or radiation pneumonitis requiring steroids
  • Positive for hepatitis B (with HBV-DNA > 500 IU/mL), hepatitis C RNA, or HIV infection
  • Prolonged QTc interval or significant abnormal ECG findings
  • History of myocardial ischemia, infarction, or congestive heart failure of grade 2 or higher
  • Conditions that increase risk of QT prolongation or arrhythmic events such as coronary artery disease, hypokalemia, congenital long QT syndrome, or family history of sudden unexplained death
  • Current use of medications known to prolong QT interval

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

Loading map...

Research Team

Y

Yongchang C Zhang, MD

CONTACT

N

Nong C Yang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here