Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring pyrotinib, HER2, Non-small Cell Lung Cancer, Phase II
Eligibility 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.
Sites / Locations
- Department of Oncology, Shanghai pulmonary hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pyrotinib treatment arm
Arm Description
pyrotinib treatment arm
Outcomes
Primary Outcome Measures
Objective Response Rate
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
Secondary Outcome Measures
Progression Free Survival
PFS is evaluated in 24 months since the treatment began
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02535507
Brief Title
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
pyrotinib, HER2, Non-small Cell Lung Cancer, Phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pyrotinib treatment arm
Arm Type
Experimental
Arm Description
pyrotinib treatment arm
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
Time Frame
tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
PFS is evaluated in 24 months since the treatment began
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
overall survival
Description
evaluated in the 24th month since the treatment began
Time Frame
24 months
Title
Safety and Tolerability
Description
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Time Frame
24 months
Title
quality of life (measured by questionnaire)
Description
Change from baseline in Pain on the 11 point short pain scale (SPS-11)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caicun Zhou, MD,PhD
Phone
86-65115006-3050
Email
caicunzhoudr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD,PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Shanghai pulmonary hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun zhou, MD, PhD
Phone
86-65115006-3050
Email
caicunzhoudr@126.com
First Name & Middle Initial & Last Name & Degree
shengxiang Ren, MD,PhD
Email
harry_ren@126.com
First Name & Middle Initial & Last Name & Degree
Shengxiang Ren, MD,PhD
First Name & Middle Initial & Last Name & Degree
Fengying Wu, MD,
First Name & Middle Initial & Last Name & Degree
Xiaoxia Chen, MD,PhD
First Name & Middle Initial & Last Name & Degree
Chunxia Su, MD,PhD
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30596880
Citation
Wang Y, Jiang T, Qin Z, Jiang J, Wang Q, Yang S, Rivard C, Gao G, Ng TL, Tu MM, Yu H, Ji H, Zhou C, Ren S, Zhang J, Bunn P, Doebele RC, Camidge DR, Hirsch FR. HER2 exon 20 insertions in non-small-cell lung cancer are sensitive to the irreversible pan-HER receptor tyrosine kinase inhibitor pyrotinib. Ann Oncol. 2019 Mar 1;30(3):447-455. doi: 10.1093/annonc/mdy542.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
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