A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

March 27, 2017 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

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

To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS).

A secondary aim is to obtain safety information.

To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Changsha, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Guangzhou, China
        • Not yet recruiting
        • HR-BLTN-II-NSCLC Investigational Site
      • Hangzhou, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Harbin, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Nanjing, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Suzhou, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
      • Wuhan, China
        • Not yet recruiting
        • HR-BLTN-II-NSCLC Investigational Site
      • Zhengzhou, China
        • Recruiting
        • HR-BLTN-II-NSCLC Investigational Site
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ECOG performance status of 0 to 1.
  2. Life expectancy of more than 3 months.
  3. At least one measurable lesion exists.(RECIST 1.1).
  4. Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009.
  5. Failed prior therapies.(RECIST 1.1).
  6. Confirmed HER2 mutation by Central Laboratory。
  7. More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.

  8. Required laboratory values including following parameters:

    ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤2 x ULN or ALT and AST: ≤5x ULN for patients with liver metastasis; BUN and Cr: ≤1.5 x ULN； creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms for female and < 450 ms for male.

  9. Signed informed consent

Exclusion Criteria:

  1. Previous therapy with other HER2 inhibitors.
  2. History of severe hypersensitivity reactions to the excipients of the trial drugs.
  3. Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
  4. Active brain metastases
  5. Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
  6. Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
  7. Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
  8. Uncontrolled hypertensin,diabetes.
  9. unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
  10. Active infection
  11. Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
  12. History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  13. 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.
  14. Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  15. Known history of neurological or psychiatric disease, including epilepsy or dementia.
  16. Treatment in another clinical trial within the past 4 weeks before start of therapy
  17. Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pyrotinib treatment
Drug: pyrotinib
Other Names:
  • BLTN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: up to 24 months
up to 24 months
Incidence and Intensity of Adverse Events
Time Frame: From signing informed consent document until 28 days after the last drug administration
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
From signing informed consent document until 28 days after the last drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 27, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (ESTIMATE)

July 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-BLTN-Ⅱ-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan havn't been decided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung

Clinical Trials on pyrotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe