Non-small cell lung cancer with brain metastasis
Conditions
Interventions
Control group:Chemotherapy phase: chemotherapy + camrelizumab (4-6 cycles of treatment), cranial radiotherapy (started before the end of 4 cycles of chemotherapy)
Maintenance phase: camrelizumab until disease progression or uncontrolled toxicity, immune maintenance for up to 2 years.
Experimental group:Chemotherapy phase: chemotherapy + camrelizumab + low-dose bevacizumab (4-6 cycles), cranial radiotherapy (started before the end of 4 cycles of chemotherapy)
Maintenance phase: camrelizumab + low-dose bevacizumab until disease progression or uncontrolled toxicity, immunization and bevacizumab for up to 2 years.
Sponsors
Chongqing university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with histologically or cytologically confirmed non-small cell lung cancer with radiologically diagnosed brain metastases; 2.There is at least one objectively measurable lesion in the brain. 3.Extracranial lesions confirmed by CT or MRI, with at least one lesion measurable according to RECIST 1.1 criteria; 4.Without known EGFR mutation, ALK fusion positive, ROS1 mutation positive, or other gene mutation suitable for targeted therapy(such as BRAF V600E,MET 14 Exon Skipping mutation, RET fusion positive),but subjects refuse to receive targeted therapy,or non- adenocarcinoma subjects without gene test; 5.Age 18-75 years old, male or female; 6.No previous chemotherapy or more than 3 weeks (21 days) since the end of the last chemotherapy; 7.Subjects who did not receive any treatment for brain metastases; 8.ECOG) 0 ~ 2 ; Life expectancy >=3 months; 9.Patients who participated in the study voluntarily, fully understood the content of the study, signed informed consent, and were willing to accept follow-up; 10.Patients who can cooperate with treatment, and follow-up; 11.The function of major organs was determined by the investigator to be consistent with the treatment of the center.
Exclusion criteria
Exclusion criteria: 1.Patients with meningeal or spinal cord metastases; 2.Patients with active intracranial hemorrhage; 3.Central type of squamous cell carcinoma with a high risk of bleeding or cavity lesions adjacent to large blood vessels (including but not limited to central type of lung cancer with invasion of large blood vessels or direct invasion of bronchus); 4.PD-L1>=50%; 5.Systemic corticosteroids (>=10 mg/ day, prednisone, or equivalent of other corticosteroids) or immunosuppressant therapy were required for 7 consecutive days within 14 days prior to the first administration of the study; Except for inhaled or topical use of hormones, or physiological replacement dose of hormone therapy due to adrenal insufficiency; Allow short-term (150 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy, and active bleeding, pulmonary hemorrhage, moderate to large hemoptysis or bloody ascites; 14.History of concurrent gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis, and other gastrointestinal disorders that may cause gastrointestinal bleeding or perforation. 15.Patients with a history of grade 4 venous embolism (including pulmonary embolism); 16.Severe uncontrolled recurrent infections include abdominal infections, or other serious uncontrolled concomitant diseases (such as uncontrolled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.); 17.less than 28 days after received major surgery. 18.Known history of psychotropic substance abuse or drug abuse. 19.Patients of reproductive age (including men) who refuse to use contraception; 20.Those who were assessed may be at unnecessary risk after treatment with the study protocol;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunotherapy-based combination of bevacizumab regimen for progression-free survival (PFS) in patients with nsNSCLC brain metastases.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Intracranial progression-free survival (iPFS);Extracranial progression-free survival (ePFS); | — |
Countries
China
Contacts
Public ContactDingyi Yang
Affiliated Cancer Hospital of Chongqing University
Outcome results
None listed