NSCLC
Conditions
Interventions
Experimental group:Adebrelimab:1200mg,IV,D1,Q3W
Famitinib Malate:20mg,PO,QD,Q3W
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 years and above, male and female; 2) Patients with histologically or pathologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 =50% and brain metastases on imaging.There is no restriction on the testing organization for the PD-L1 test, and the test results provided by medical institutions or third-party institutions that comply with the requirements of the state and have relevant certificates are recognized. 3) ECOG score of 0-2. 4) Life expectancy of at least 3 years; 4) Have a life expectancy of at least 3 months; 5) no prior systemic therapy for NSCLC (but may have received brain radiotherapy, received adjuvant therapy ending = 6 months ago, and = 2 prior doses of bevacizumab) 6) At least one measurable lesion based on the criteria for the evaluation of the efficacy of solid tumors (RECIST 1.1). The longest diameter measured by spiral CT is =10 mm, and at least one intracranial lesion is =5 mm in diameter. (Measurable lesions are not required for postoperative recurrence with brain metastases). 7) Normal function of major organs, i.e., meeting the following criteria (without symptomatic treatment within 7 days): a) Routine blood tests: Hemoglobin (Hb) =80g/L; Platelet (PLT) =80×109/L; Neutrophil count (ANC) =1.5×109/L; White blood cell count (WBC) =3.0×109/L; b) Biochemical tests: Albuminous aminotransferase (ALT) and albuminous aminotransferase (AST) = 2.5 × ULN; ALT AST = 5 ULN in those with liver metastases; Those with liver metastases or bone metastases: ALP = 5 ULN; serum total bilirubin (TBIL) = 1.5 x ULN (= 3 x ULN in subjects with Gilbert's syndrome); albumin (ALB) = 25 g/L; renal function: serum creatinine = 1.5 x ULN or creatinine clearancerate (creatinine clearancerate , CrCl) =50mL/minute (using the Cockcroft/Gault formula); c) Coagulation: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5 x ULN; d) Other: lipase = 1.5 x ULN. if lipase > 1.5 x ULN No clinical or imaging confirmation of pancreatitis may be enrolled; 8) Participants with impaired decision-making ability whose neurological or psychological condition does not preclude them from safely participating in the study (e.g., neurological dysfunction due to metastatic brain lesions may be enrolled in this study); 9) Non-surgically sterilized female subject patients of childbearing potential of childbearing potential must have a negative serum or urine HCG test within 72 h prior to enrollment in the study for the first dose of study medication, are required to use a medically approved contraceptive (e.g., IUD, birth control pills, or condoms) for the duration of the study treatment period and for 90 days following the end of the study treatment period and must be not breastfeeding; in the case of males, agreement should be given to use a medically approved contraceptive (e.g., IUD, birth control pills, or condoms) during the trial and 90 days following the last dose of study medication. and for 90 days after the last dose of trial drug is given, to use a highly effective method of contraception. 10) Female participants must agree not to breastfeed during the study or for 180 days after the last dose of study treatment. 11) Participants must agree not to donate blood during the study or for 90 days after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1) Subject has developed extensively active meningeal metastases, midbrain metastases, pontine metastases, medullary metastases, or spinal cord metastases; 2) Spinal cord compression not definitively treated by surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without evidence that the disease has been clinically stable for at least 1 week prior to randomization to subgroups; 3) Uncontrolled or symptomatic hypercalcemia; 4) Consecutive use of immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor medications, according to a dose of no more than 10 mg/day of prednisolone or equivalent pharmacologic dose of any other corticosteroid with a discontinuation of = 5 half-lives) within 7 days prior to the first dose of adebenosumab. Excludes nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids; 5) Patient has a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., occlusive capillary bronchiolitis), drug-induced pneumonia, radiation pneumonitis requiring steroids, or active pneumonitis with clinical symptoms; or other moderate to severe lung disease that severely affects lung function (history of radiation pneumonitis (fibrosis) in the field of radiation is permitted); 6) Active tuberculosis (TB) or history of active TB infection within 48 weeks prior to screening, regardless of whether they have received treatment; 7) have received or are scheduled to receive prophylactic or live attenuated vaccine within 4 weeks prior to the first dose; 8) have a history of allogeneic bone marrow transplantation or solid organ transplantation 9) the presence of severe cardiovascular disease: grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms in men and =470 ms in women); grade III-IV cardiac insufficiency (according to the New York Heart Association NYHA classification), or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) <50%; 10) Presence of any active autoimmune disease or history of autoimmune disease (e.g., other conditions deemed inappropriate for enrollment by the investigator) shall not be included; exceptions are: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy; and patients with type 1 diabetes mellitus who are glycemic-controlled after treatment with insulin-delivered regimens; 11) Major surgery or severe traumatic injury, fracture, or ulcer within 4 weeks prior to planned enrollment, or scheduled to undergo major surgery during the study period; 12) Serious infection such as severe sepsis or infectious shock within 14 days prior to planned enrollment, including but not limited to hospitalization for complications such as infection, bacteremia, or severe pneumonia; 13) Clinically significant hemoptysis of fresh blood or hemoptysis greater than one-half teaspoon (2.5 ml) or more per day within 4 weeks prior to planned enrollment; or clinically significant hemorrhagic symptoms or a definite bleeding tendency, such as gastrointestinal hemorrhage, hemorrhagic gastric ulcers, fecal occult blood of +++ or more at baseline, or suffering from vasculitis; 14) HBsAg positivity above the upper limit of normal (1000 copies/ml or 500 IU/ml); patients with previous hepatitis B virus (HBV) infection or cured HBV
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate,DCR;Progression-free survival,PFS;Intracranial progression-free survival,iPFS;Duration of Response,DoR;Intracranial Duration of Response,iDoR;Overall survival,OS; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Countries
China
Contacts
Public ContactXiaoyan Li
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed