Brief Summary

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Oct 2016

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

July 13, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

October 20, 2016

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

July 13, 2016

Last Update Submit

August 21, 2025

Conditions

Non Small Cell Lung

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Progression Free Survival (PFS)
up to 24 months
Incidence and Intensity of Adverse Events
From signing informed consent document until 28 days after the last drug administration

Study Arms (1)

pyrotinib treatment

EXPERIMENTAL

Drug: pyrotinib

Interventions

pyrotinibDRUG

Also known as: BLTN

pyrotinib treatment

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Previous therapy with other HER2 inhibitors.
History of severe hypersensitivity reactions to the excipients of the trial drugs.
Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
Active brain metastases
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
Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
Uncontrolled hypertensin,diabetes.
unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure\>NYHA II, serious cardiac arrhythmia
Active infection
Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
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.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jiangsu HengRui Medicine Co., Ltd.lead