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

Tongji University

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Pyrotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02535507

FK1406

Details and patient eligibility

About

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.

Full description

This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.

To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.