Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Pyrotinib Combined with chemotherapy
Control group:Chemotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, no gender limit; 2. ECOG status score is 0-2; 3. Life expectancy is at least 12 weeks; 4. ?b-?stage NSCLC patients confirmed by histology or cytology; 5. Definition of HER2-mutant NSCLC: insertion mutation and point mutation of HER2 gene were confirmed by gene detection of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other samples; 6. Previous treatment: Patients with inoperable locally advanced or advanced stage who have not received systematic treatment, i.e. the18-75 years old, no gender limit; 7. There was at least one measurable lesion with a diameter of more than 10 mm in imaging examination; 8. Left ventricular ejection fraction (LVEF) >= 50% by echocardiography; 9. The organ function level must meet the following requirements: (1) Bone marrow: hemoglobin(Hb) >= 100g/L,absolute neutrophil count(ANC) >= 1.5 x 10^9/L, platelet(PLT) >= 7.5 x 10^9 /L (2) Blood-related biochemistry:TBIL <= 1.5 x ULN;ALT ? AST <= 2.5 x ULN, ALT?AST <= 5 x ULN in case of liver metastasis;Serum creatinine <= 1.5 x ULN; 10. Fully understand this research and voluntarily sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. There is effusion in the third space which can not be controlled by drainage or other methods, such as pleural effusion and ascites; 2. Uncontrollable important history of respiratory system, such as bronchiectasis, chronic obstructive pulmonary disease, pulmonary abscess, pulmonary embolism, etc; 3. Major surgical operation or severe traumatic injury, fracture, or wound with poor healing within 4 weeks; 4. Active severe clinical infection (NCI-CTCAE, version 5.0, > grade 2 infection standard) and hepatitis B, hepatitis C, syphilis and HIV infection; 5. Symptomatic brain metastasis or meningeal metastasis; 6. Combined with previously untreated tumors other than primary lung cancer; 7. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 8. There are many factors affecting the oral administration and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 9. Those who have been proved to be allergic to the drug components of this scheme; 10. Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are not willing to take effective contraceptive measures during the whole trial period; 11. The patient has a serious accompanying disease, or any other situation that the researcher thinks the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHu Yi
PLA General Hospital
Outcome results
None listed