Non-small cell lung cancer
Conditions
Interventions
experimental group:Ametinib + pemetrexed + carboplatin
control group:Ametinib
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age is 18 to 75 years old; 2. ECOG performance status (PS) 0 to 1 grade; 3. The expected survival period is not less than 12 weeks; 4. Pathologically confirmed IIIB (not suitable for radiotherapy), stage IV non-squamous non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, the longest CT scan of tumor lesions >= 10mm, the shortest CT scan of lymph node lesions >= 15mm, Measurable lesions have not received local treatment such as radiotherapy and freezing); 5. According to any proven method, the patient's primary non-squamous non-small cell lung cancer exhibits EGFR activating mutations (exon 19 deletion or 21 exon L858R point mutation); 6. No previous chemotherapy or other targeted therapy; Note: The treatment used in the neoadjuvant treatment phase is not included in the treatment plan; if the recurrence is within 6 months after the end of the adjuvant treatment, the adjuvant treatment is defined as first-line treatment and cannot be included in the study; if the recurrence exceeds 6 months, the adjuvant treatment plan Not included in the treatment plan; 7. Patients who have previously received radiotherapy can be enrolled, but the radiotherapy area must be = 1.5*10^9/L; b) Hb >= 100g/L; c) PLT >= 100 * 10^9/L; (No blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors) 2) Biochemical examination should meet the following standards: a) TBIL = 50ml/min (Cockcroft-Gault formula); 9. Women of childbearing age must have taken reliable contraception or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the result was negative, and they are willing to use appropriate methods for contraception during the test and 8 weeks after the last test drug administration. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the test and 8 weeks after the last test drug administration; 10. The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous cell carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell lung cancer); 2. Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before enrollment and have stable symptoms can be enrolled, but need to be confirmed to have no cerebral hemorrhage symptoms by cranial MRI, CT or venography evaluation); 3. Imaging (CT or MRI) shows that the tumor is = 450ms, female >= 470ms); according to NYHA standards, grade III ~ IV cardiac insufficiency, or heart Color Doppler ultrasound examination showed that left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT)>ULN+4 seconds or APTT > 1.5ULN), have bleeding tendency or are undergoing thrombolysis or anticoagulation treatment; 9. The amount of hemoptysis reached two teaspoons or more per day before enrollment; 10. Significant clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhoidal hemorrhoids, hemorrhagic gastric ulcer, occult blood in the stool at baseline, or more, or suffering from vasculitis within 3 months before enrollment Wait; 11. Arterial/venous thrombotic events within 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 12. Known predispositions for inherited or acquired bleeding and thrombosis (such as hemophiliacs, coagulopathy, thrombocytopenia, hypersplenism, etc.); 13. Long-term unhealed wounds or fractures (pathological fractures caused by tumors are not counted); 14. Have undergone major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 15. There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 16. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment: 17. Urinary routines suggest that urine protein is >= ++, or that the 24-hour urine protein amount is >= 1.0g; 18. Serous effusion (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms and symptomatic treatment; Note: Asymptomatic serous cavity effusions can be included in the group. Symptomatic serous cavity effusions are actively treated symptomatically (cannot be treated with anticancer drugs for serous effusions). Patients who can be included in the group are judged by the investigator To allow group entry; 19. Active infection requires antimicrobial treatment (for example, antibacterial drugs and antiviral drugs are required, excluding chronic hepatitis B, hepatitis B, and antifungal drugs); 20. Those who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;TTPD;DoR;QoL; | — |
Countries
China
Contacts
Public ContactTan Liping
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed