Actively Recruiting
Efficacy and Safety of LMV-12 (HE003) Combined With Osimertinib in Advanced Non-Small Cell Lung Cancer Previously Treated With EGFR Inhibitors
Led by Hunan Province Tumor Hospital · Updated on 2024-05-30
120
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of a drug called HE003 combined with osimertinib in patients with advanced solid tumors, specifically those who have not responded to previous standard therapies. This open-label, single-arm, dose-escalation, multicenter phase I/II clinical trial focuses mainly on advanced non-small cell lung cancer (NSCLC) patients with specific genetic alterations, such as MET amplification or RET fusion, who have failed prior EGFR inhibitor treatments. The study involves administering LMV-12 (HE003) in cycles of 28 days, with doses of 30 mg or 60 mg taken continuously for 21 days followed by a 7-day break. Osimertinib is given at 80 mg daily throughout each 28-day cycle. Participants are divided into cohorts based on genetic markers: one with MET amplification and another with RET fusion. The trial aims to assess the combined treatment's safety and efficacy over time, with multiple patient groups receiving the experimental therapy. Participants will be closely monitored through laboratory tests and clinical evaluations to assess organ function and treatment response. Researchers will track outcomes like overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events over a period of up to 36 months from the first dose. The study includes regular follow-ups to evaluate treatment effects and safety in this patient population with advanced NSCLC.
CONDITIONS
Brief Title
The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Age 18 years or older
- Any gender
- Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer not eligible for surgery
- Relapsed after failure of previous treatment with first-line EGFR inhibitors (including first, second, and third generation)
- Cohort A: MET amplification confirmed by FISH, NGS, or IHC
- Cohort B: RET fusion
- Laboratory values within specified limits: neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN (higher allowed if liver metastases present)
- Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
- Negative pregnancy test within 7 days before treatment for premenopausal women and use of adequate contraception during and 3 months after treatment
You will not qualify if you...
- Use of CYP isozyme inducers or inhibitors within 3 weeks prior to enrollment
- Pregnant or breastfeeding women
- History of immunodeficiency or congenital/acquired immunodeficiency diseases
- Prior bone marrow or solid organ transplantation
- Presence of gastrointestinal perforation or fistula
- History of interstitial lung disease or drug-induced lung disease requiring steroid therapy
- Active hepatitis B or C infection or HIV positive (with some exceptions for controlled hepatitis B and negative HCV RNA)
- Cardiac abnormalities including prolonged QT interval, conduction blocks, myocardial ischemia or infarction, congestive heart failure (NYHA class ≥2), or risk factors for arrhythmia
- Use of medications known to prolong QT interval or family history of long QT syndrome or sudden unexplained death before age 40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive LMV-12(HE003) combined with Osimertinib. LMV-12 is taken continuously for 21 days followed by 7 days off in each 28-day cycle, while Osimertinib is taken continuously for 28 days per cycle.
Visits occur with each treatment cycle as per protocol
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang C Zhang, MD
N
Nong C Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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