Non-small Cell Lung Cancer
Conditions
Keywords
pyrotinib, HER2, Non-small Cell Lung Cancer, Phase II
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.
Interventions
DRUGPyrotinib
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed
Sponsors
Tongji University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months | To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 24 months | PFS is evaluated in 24 months since the treatment began |
Other
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 24 months | evaluated in the 24th month since the treatment began |
| Safety and Tolerability | 24 months | Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0 |
| quality of life (measured by questionnaire) | 24 months | Change from baseline in Pain on the 11 point short pain scale (SPS-11) |
Countries
China
Contacts
Primary ContactCaicun Zhou, MD,PhD
Outcome results
None listed