OncoMatch/Clinical Trials/NCT06109558
The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC
Is NCT06109558 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies LMV-12(HE003) for non small cell lung cancer.
Treatment: LMV-12(HE003) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET amplification
Required: RET fusion
Disease stage
Metastatic disease required
Prior therapy
Must have received: egfr tyrosine kinase inhibitor — first-line
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
Bilirubin ≤1.5 times ULN; AST and ALT ≤2.5 times ULN (total bilirubin ≤3 times ULN and AST and ALT ≤5 times ULN if hepatic metastases present)
Cardiac function
QTc ≤470 msec (women) or ≤450 msec (men); no significant arrhythmias, conduction abnormalities, or heart failure ≥ grade 2 (NYHA); no factors increasing risk of QTc prolongation
Laboratory tests for organ function levels must meet the following requirements: Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL; Bilirubin ≤1.5 times ULN; 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); Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula); 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)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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