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This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation.
To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS).
A secondary aim is to obtain safety information.
To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Enrollment
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Volunteers
Inclusion criteria
ECOG performance status of 0 to 1.
Life expectancy of more than 3 months.
At least one measurable lesion exists.(RECIST 1.1).
Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009.
Failed prior therapies.(RECIST 1.1).
Confirmed HER2 mutation by Central Laboratory。
More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.
Required laboratory values including following parameters:
ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤2 x ULN or ALT and AST: ≤5x ULN for patients with liver metastasis; BUN and Cr: ≤1.5 x ULN; creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms for female and < 450 ms for male.
Signed informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
55 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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