OncoMatch/Clinical Trials/NCT05751018
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer
Is NCT05751018 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Pyrotinib for non-small cell lung cancer.
Treatment: Pyrotinib — This is a multicenter, single-arm phase II clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified non-small cell lung cancer. Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification
Required: HER2 (ERBB2) insertion mutation
Required: HER2 (ERBB2) point mutation
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: egfr tyrosine kinase inhibitor
Lab requirements
Blood counts
Neutrophil count (ANC) ≥ 1,500/mm3; Platelet count (PLT) ≥ 75,000/mm3; Hemoglobin (Hb) ≥ 8 g/dL
Kidney function
Serum creatinine (SCr) ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin (TBIL) ≤ 1.5x ULN; AST or ALT ≤ 2.5x ULN (≤ 5x ULN with liver metastases)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
bone marrow function, liver and kidney function...ANC ≥ 1,500/mm3; PLT ≥ 75,000/mm3; Hb ≥ 8 g/dL; SCr ≤ 1.5x ULN or CrCl ≥ 60 mL/min; TBIL ≤ 1.5x ULN; AST or ALT ≤ 2.5x ULN (≤ 5x ULN with liver metastases); LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05751018 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 insertion mutation is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 point mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify