NSCLC
Conditions
Interventions
Experimental group:Almonertinib 110mg PO once daily plus apatinib 250mg PO once daily
Control group:Almonertinib 110mg PO once daily
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1 and has not deteriorated at least 2 weeks before the study drug treatment, and the expected survival period is not less than 12 weeks; 3. Histology or cytology confirmed locally advanced or metastatic stage IIIB-IV NSCLC (including relapsed or newly diagnosed advanced patients after previous surgical treatment; according to AJCC eighth edition lung cancer staging standards); 4. After the diagnosis of stage IIIB-IV NSCLC, he has not received any systemic treatment. For patients who have received local treatment, if the lesion within the scope of the local treatment is a non-target lesion, the patient can participate in the study; 5. Patients who have previously received preoperative neoadjuvant chemotherapy, postoperative adjuvant chemotherapy, and concurrent radiotherapy and chemotherapy must meet the conditions of having completed the treatment for more than 6 months (including 6 months); 6. Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including but not limited to exon 19 deletion, exon 21L858R, exon 19 insertion, L861Q, etc. including exons) by local laboratory tests approved by the investigator. 19 deletion or exon 21L858R, both exist alone or coexist with other EGFR mutations); 7. According to the RECIST 1.1 standard, the subject must have a measurable target lesion that has been examined by PET-CT or CT or MRI. Tumor imaging evaluation was performed within 28 days before the first medication; 8. Patients with asymptomatic brain metastases or brain lesions in stable condition after radiotherapy and have completed radiotherapy for more than 28 days (including 28 days) can be included in the group; 9. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy: (1) Postmenopausal is defined as amenorrhea at least 12 months after the age is over 50 years and all exogenous hormone replacement therapy is stopped; (2) For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered postmenopausal; (3) Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral fallopian tube ligation. 10. Male subjects should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment; 11. The subjects themselves participated voluntarily and signed an informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any of the following treatments: (1) Have used any EGFR tyrosine kinase inhibitor in the past; (2) Have used any VEGF receptor tyrosine kinase inhibitor or other anti-angiogenesis drugs in the past; (3) Within 4 weeks before the first administration of the study drug, the subject has undergone major surgery (such as craniotomy, thoracotomy, or laparotomy, etc., as determined by the investigator. Please refer to Appendix H for implementation on November 1, 2018 Level 3 and Level 4 surgery specified in the "Administrative Measures for the Clinical Application of Medical Technology"); (4) Within 7 days before the first administration of the study drug, have used strong CYP3A4 inhibitors, inducers or CYP substrates (CYP2C8, CYP2D6, etc.). 2. Combined with other malignant tumors, except skin basal cell carcinoma and carcinoma in situ; 3. At the beginning of the study treatment, there are unresolved residual toxicity from the previous treatment that is greater than CTCAE level 1, except for hair loss and level 2 neurotoxicity caused by previous chemotherapy; 4. Suspected of active pulmonary tuberculosis infection or acquired immunodeficiency syndrome antibody (Anti-HIV) positive, anti-Treponema pallidum antibody (TP-Ab) positive, hepatitis B surface antigen (HBV-Ag) positive and HBV DNA copy number> detection unit The upper limit of normal and other serious active fungal, bacterial and/or viral infections, etc; 5. Severe gastrointestinal dysfunction, which may affect the intake, transport or absorption of drugs, such as inability to take orally drugs, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, uncured recurrent diarrhea, atrophic gastritis , Uncured gastric diseases, Crohn's disease, ulcerative colitis, etc. that require long-term use of proton pump inhibitors; 6. Hepatic encephalopathy, hepatorenal syndrome or cirrhosis; 7. Abnormal coagulation function (APTT > 1.5 x ULN or INR > 1.5), receiving thrombolysis, anticoagulation or antiplatelet therapy, bleeding tendency or active bleeding (such as hemoptysis, gastrointestinal bleeding, etc.); Arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism, occurred 6 months before the start of the study; 8. Those who have high blood pressure and cannot fall into the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure > 90 mmHg); 9. There are wounds or fractures that have not healed for a long time; 10. Urine routine test indicates urine protein >=++, or 24-hour urine protein quantitative > 1.0 g; 11. Have 3-4 grade cardiac insufficiency (NYHA standard) or meet any of the following cardiac examination results: (1) The average value of QT interval (QTcF) corrected by Fridericia's formula obtained from 3 ECG examinations at rest> 470 msec; (2) Resting ECG suggests conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block and PR interval> 250 msec, etc.); (3) There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval; (4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall survival;Objective response rate;Disease control rate;Duration of relief;Intracranial objective response rate;Patient quality of life;Safety; | — |
Countries
China
Contacts
Public ContactHu Yi
Chinese PLA General Hospital
Outcome results
None listed