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

• Sponsor: Tongji University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02535507
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Pyrotinib	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyrotinib treatment arm pyrotinib treatment arm	Drug: Pyrotinib; Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate [tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months]

   To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib

Secondary Outcome Measures

1. Progression Free Survival [24 months]

   PFS is evaluated in 24 months since the treatment began

Other Outcome Measures

1. overall survival [24 months]

   evaluated in the 24th month since the treatment began

2. Safety and Tolerability [24 months]

   Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

3. quality of life (measured by questionnaire) [24 months]

   Change from baseline in Pain on the 11 point short pain scale (SPS-11)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Shanghai pulmonary hospital	Shanghai		China	200433

Sponsors and Collaborators

• Tongji University

Investigators

• Principal Investigator: Caicun Zhou, MD,PhD, Shanghai Pulmonary Hospital, Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caicun Zhou, MD,PhD, Tongji University
• ClinicalTrials.gov Identifier: NCT02535507
• Other Study ID Numbers: FK1406
• First Posted: Aug 28, 2015
• Last Update Posted: Aug 28, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Caicun Zhou, MD,PhD, Tongji University: pyrotinib; HER2; Non-small Cell Lung Cancer; Phase II
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 28, 2015