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At present, the main characteristics of the enrolled population in the clinical study of HER2-mutated non-small cell lung cancer are the YVMA mutation type. There are no relevant clinical trials specifically targeting rare mutation types. Pyrotinib has been approved for the treatment of HER2-positive advanced breast cancer in China, and pyrotinib has shown good development prospects in the treatment of advanced non-small cell lung cancer. The purpose of this study is to observe the efficacy and safety of pyrotinib maleate in patients with HER2 rare mutation in advanced non-small cell lung cancer.
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Inclusion criteria
Before using the drug for the first time, it was confirmed by laboratory tests that the subject's bone marrow function, liver and kidney function met the following requirements:
Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), and subjects with liver metastases should be ≤ 5×ULN;
International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
Urine protein <2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;
Exclusion criteria
15 participants in 1 patient group
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Central trial contact
Xinyong Zhang, Master; Ying Hu, Doctor
Data sourced from clinicaltrials.gov
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