Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji University

Criteria

Inclusion Criteria:

• Aged ≥18 and ≤80 years.

• ECOG performance status of 0 to 1.

• Life expectancy of more than 12 weeks.

• At least one measurable lesion exists.(RECIST 1.1)

• Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.

• Required laboratory values including following parameters:

ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin:

≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms

• Signed informed consent.

Exclusion Criteria:

• Subjects with third space fluid that can not be controled by drainage or other methods.

• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.

• Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy

• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.

• Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.

• Receiving any other antitumor therapy.

• Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).

• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.

• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.

• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.

• Known history of neurological or psychiatric disease, including epilepsy or dementia.