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 (May 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
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.
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