BridgeMD
Tests treatment safety and results for Non Small Cell Lung Cancer
Official title The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC
ClinicalTrials.gov ID: NCT06109558
What this study is testing
What is LMV-12(HE003)?
LMV-12(HE003) is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Osimertinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible people selected for this study must meet all of the following criteria:
- Sign written informed consent before implementing any trial-related procedures;
- Age ≥18 years old;
- No limit on the gender;
- Histological or cytological confirmed advanced or metastatic non-small cell lung cancer, ineligible for radical surgery, relapse after failure of...
You likely can't join if
- people treated with CYP isozyme inducers or inhibitors (see Appendix 4 for details) within 3 weeks prior to enrollment;
- Pregnant or lactating women;
- History of immunodeficiency or other acquired, congenital immunodeficiency diseases;
- Patients with prior bone marrow transplantation or prior solid organ transplantation;
- Patients with a combination of gastrointestinal perforation, gastrointestinal fistula, or non-gastrointestinal fistula;
- Prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence...
See the full eligibility criteria
- Eligible people selected for this study must meet all of the following criteria:
- Sign written informed consent before implementing any trial-related procedures;
- Age ≥18 years old;
- No limit on the gender;
- 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...
- Laboratory tests for organ function levels must meet the following requirements:
- Absolute neutrophil count ≥ 1.5 × 109/L;
- Platelet count ≥ 100 × 109/L;
- Hemoglobin ≥ 9 g/dL;
- Bilirubin ≤1.5 times ULN; e) AST and ALT ≤2.5 times ULN (total bilirubin ≤3 times the upper limit of normal and AST and ALT ≤5 times the upper limit of normal are permitted if hepatic metastases are present); f) Serum...
- For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, a serum pregnancy test must be negative, and they must be non-lactating; all enrolled...
- people treated with CYP isozyme inducers or inhibitors (see Appendix 4 for details) within 3 weeks prior to enrollment;
- Pregnant or lactating women;
- History of immunodeficiency or other acquired, congenital immunodeficiency diseases;
- Patients with prior bone marrow transplantation or prior solid organ transplantation;
- Patients with a combination of gastrointestinal perforation, gastrointestinal fistula, or non-gastrointestinal fistula;
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.