Non-small Cell Lung Cancer
Conditions
Interventions
Targeted Therapy:Pyrotinib and Apatinib
Sponsors
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 70 years; 2) Histologically or cytologically confirmed non-small cell lung cancer with stage IV disease; 3) HER2 exon 20 insertion mutations, primary HER2 missense mutations or primary HER2 amplification (HER2 copy number detected by NGS testing >= 3.62 or HER2 FISH+) confirmed by tumor tissue or plasma, pleural effusion, cerebrospinal fluid or other specimens; 4) Pretreated with first-line chemotherapy or ErbB-TKI targeted therapy and had experienced disease progression; 5) At least one radiographically measurable lesion exists; 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7) Life expectancy of more than 12 week; 8) Left ventricular ejection fraction (LVEF) >= 50 percent (%) by echocardiogram (ECHO); 9) Adequate hepatic, renal, and hematologic functions are required including following parameters; a. ANC>= 1.5 x 10^9/L (1,500/mm3) b. Platelet count: >= 100 x 10^9/L (100,000/mm3) c. Hemoglobin >= 80 g/L (8 g/dL) d. SCr= 60 mL/min e. Total bilirubin = 2+, 24-hour urine protein quantitation shows that protein must be <= 1g; 10) Provide written, informed consent to participate in the study and follow the study procedures.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrolled blood pressure on medication (>140/90 mmHg), uncontrolled or severe cardiovascular disease, such as refractory angina and congestive heart failure within 6 months of enrollment, history of myocardial infarction within 12 months of enrollment; subjects had any heart disease requiring medication or clinically significant ventricular arrhythmia, QT prolongation, history of cerebrovascular accident, symptomatic and requiring medically treated coronary heart disease; 2) Significant dysfunction of the digestive tract, may affect the intake, transport or absorption of oral drugs(such as unable to swallow, chronic diarrhea, bowel obstruction, et al); 3) Recent history of active bleeding, clinically significant bleeding, and patients with clear bleeding tendency, such as hemoptysis, gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + and above, et al; 4) Major surgery or severe traumatic injury, fracture, or poor healing wound within 4 weeks; 5) Uncontrollable important respiratory history such as bronchiectasis, chronic obstructive pulmonary disease, lung abscess, pulmonary embolism, et al; 6) Serious uncontrolled clinical infection (greater than Common Terminology Criteria for Adverse Event(CTCAE) 5.0 grade 2) and current known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) and syphilis; 7) Active brain metastasis or meningeal metastasis; 8) Concomitant with previously untreated tumors other than primary lung cancer; 9) Treatment in another clinical trial within the past 4 weeks before start of therapy; 10) Previous therapy with pyrotinib and/or apatinib; 11) Known hypersensitivity to any component of pyrotinib and/or apatinib; 12) Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; 13) Patients with severe concomitant diseaseor any of the other conditions of which researchers believe that the patient is not fit to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactWang Yan
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
Outcome results
None listed