Clinical Trials /

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

NCT02834936

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: HR-BLTN-Ⅱ-NSCLC
  • NCT ID: NCT02834936

Conditions

  • Non Small Cell Lung

Interventions

DrugSynonymsArms
pyrotinibBLTNpyrotinib treatment

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
pyrotinib treatmentExperimental
  • pyrotinib

Eligibility Criteria

        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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

Last Updated

March 27, 2017