Non-small cell lung cancer
Conditions
Interventions
Group 1:Anlotinib plus Icotinib
Group 2:placebo plus Icotinib
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily joined the study and signed informed consent; 2) Male or female patients between the ages of 18-75 years; 3) ECOG PS 0-1 points; 4) The expected survival period more than 3 months; 5) Pathologically confirmed IIIB (not suitable for radiotherapy), stage IV non-small cell lung cancer, with measurable lesions (according to RECIST 1.1, CT scan long diameter 10mm, lymph node lesion CT scan short diameter >= 15mm, The measurable lesions have not received local treatment such as radiotherapy or freezing); 6) According to any validated method, the patient has a EGFR activating mutation (exon 19 deletion or 21L858R point mutation) in primary non-small cell lung cancer; 7) Have not received chemotherapy or other targeted therapies in the past; Note: The treatment used in the neoadjuvant treatment phase is not included in the treatment plan; the recurrence within 6 months after the end of adjuvant therapy is defined as first-line treatment and cannot be included in the study; more than 6 months of recurrence, adjuvant treatment Not included in the treatment plan. 8) Patients who have previously received radiation therapy can be enrolled, but the radiotherapy area must be 100g/L; Absolute neutrophil count (ANC) >1.5×10^9/L; Platelets >100×10^9/L; (2) biochemical tests: Serum total bilirubin =5Oml/min (Cockcroft-Gault formula); 10) Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to treatment and the results are negative and willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1) squamous cell carcinoma (including adenosquamous carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer); 2) Symptomatic brain metastasis (patients with brain metastases who have completed treatment and have stable symptoms 21 days before enrollment may be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms); 3) Imaging (CT or MRI) shows that the tumor lesion is =450ms, women >=470ms); according to NYHA criteria, grade III to IV cardiac insufficiency, Or cardiac color Doppler ultrasound examination indicates that the left ventricular ejection fraction (LVEF) is 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 9) Daily hemoptysis up to two teaspoons or more before enrollment; 10) There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic acne, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or pulse Tube inflammation, etc. 11) Events of venous/venous thrombosis occurring within the first 12 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 12) known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.); 13) Long-term unhealed wounds or fractures (not associated with pathological fractures caused by tumors); 14) Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 15) factors that have a significant impact on oral drug absorption, 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) Urine routine indicates urinary protein >=++, or confirmed 24-hour urine protein >=1.0g; 18) serous effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and need to be treated symptomatically; Note: Asymptomatic serous effusion can be enrolled, symptomatic serous effusion after active symptomatic treatment (can not use anticancer drugs for the treatment of serosal effusion), patients who can be enrolled by the investigator , allowed to join. 19) Active infections require anti-microbial treatment (eg antibiotics, antiviral drugs, chronic hepatitis B anti-hepatitis B treatment, antifungal therapy); 20) Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 21) Participated in other clinical trials of anti-tumo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;AEs;Time to progression;Duration of Response;Quality of life; | — |
Countries
China
Contacts
Public ContactYu Qitao
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed