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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

NCT ID

NCT02535507

First Posted

August 25, 2015

Last Updated

August 27, 2015

Sponsor

Tongji University

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

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

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

caicunzhoudr@126.com

First Name & Middle Initial & Last Name & Degree

shengxiang Ren, MD,PhD

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

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

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