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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535507
• Other study ID #: FK1406
• Status: Recruiting
• Phase: Phase 2
• First received: August 25, 2015
• Last updated: August 27, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2015
• Source: Tongji University
• Contact: Caicun Zhou, MD,PhD
• Phone: 86-65115006-3050
• Email: caicunzhoudr[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Pyrotinib
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed

Locations

Country	Name	City	State
China	Department of Oncology, Shanghai pulmonary hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival	evaluated in the 24th month since the treatment began	24 months	No
Other	Safety and Tolerability	Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0	24 months	No
Other	quality of life (measured by questionnaire)	Change from baseline in Pain on the 11 point short pain scale (SPS-11)	24 months	No
Primary	Objective Response Rate	To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib	tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months	No
Secondary	Progression Free Survival	PFS is evaluated in 24 months since the treatment began	24 months	No