Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Pyrotinib plus 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 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Histologically confirmed stage IIIB or IV non-small cell lung cancer; 3. HER2 insertion mutation, primary HER2 point mutation or primary HER2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens (including HER2 copy number amplification >=3.62 detected by NGS or positive FISH detection ); 4. No previous systemic anti-tumor therapy, and the patient refuses or unconditionally receives first-line chemotherapy, T-DXd and T-DM1 therapy; 5. There is at least one lesion that can be assessed by imaging; 6. ECOG score 0-2 points; 7. Expected survival period >= 3 months; 8. Cardiac ultrasound examination showed that left ventricular ejection fraction (LVEF) >= 50%; 9. The patient's bone marrow function, liver and kidney function have been confirmed by laboratory tests before the first medication to meet the following requirements: (1) Neutrophil count (ANC) >= 1,500/mm3 (1.5x10^9/L); (2) Platelet count (PLT) >= 100,000/mm3 (100x10^9/L); (3) Hemoglobin (Hb) >= 8 g/dL (80 g/L); (4) Serum creatinine (SCr) = 60 ml/min; (5) Total bilirubin (TBIL) =2+, the 24-hour urine protein quantification shows that protein must be <=1g. 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); uncontrolled or serious cardiovascular disease, such as within 6 months before screening Refractory angina, congestive heart failure; myocardial infarction within 12 months before screening; history of any clinically significant ventricular arrhythmia, prolongation of QT interval; history of cerebrovascular accident, symptomatic Drug-treated coronary heart disease; 2. Significant digestive tract dysfunction, which may affect the intake, transport or absorption of oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Patients with a history of bleeding, clinically significant bleeding symptoms, and a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + or above, vasculitis, etc.; 4. Received major surgery within 4 weeks or suffered severe traumatic injury, fracture, or wound with poor healing; 5. History of important respiratory system such as bronchiectasis, chronic obstructive pulmonary disease, lung abscess, pulmonary embolism, etc.; 6. Active serious clinical infection (>NCI-CTCAE, 3.0 version 2 infection criteria); 7. Symptomatic brain metastases or meningeal metastases; 8. Combined with previously untreated tumors other than primary lung cancer; 9. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 10. Received treatment with pyrotinib and/or apatinib; 11. Those who have serious adverse reactions and allergies to the drugs used in this group; 12. The patient has serious concomitant diseases, or any other conditions that the investigator considers the patient unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Disease Control Rate;Overall Survival;Adverse Events;Duration of Response; | — |
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
Outcome results
None listed