Lung cancer
Conditions
Interventions
Test group:Adebelizumab: 1200 mg/dose, i.v., day 1, 21 day cycle.
Cedarbenamide: 20 mg/dose, 2x/week, (days 0, 3, 7, and 10), take two weeks on and one week off, 21-day cycle.
Doxorubicin: 75 mg/m2 ad
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) =18 years of age; 2) Eastern Collaborative Oncology Group (ECOG) physical status score of 0 or 1; 3) Life expectancy of more than 3 months; 4) Histologically or cytologically confirmed diagnosis of stage IV non-squamous non-small cell lung cancer (as judged by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumour Staging Manual, 8th edition); 5) No EGFR-sensitive mutations and no ALK or ROS1 gene rearrangements; 6) Patients with at least one target lesion with a measurable diameter according to RECIST 1.1 criteria (CT scan of tumour lesion with a long diameter =10 mm, CT scan of lymph node lesion with a short diameter =15 mm, and scanning layer thickness of no more than 5 mm); 7) Previous treatment with PD-1 monoclonal antibody alone or in combination with standard chemotherapy, with a best outcome of complete remission (CR), partial remission (PR), or stable disease (SD) for = 6 months (defined as stable disease within 6 months from first PD-1 monoclonal antibody dose) and eventual progression of the disease (according to RECIST v1.1) during treatment. 8) Good major organ function: good haematopoietic function, defined as an absolute neutrophil count = 1.5 x 10^9/L, platelet count = 100 x 10^9/L, haemoglobin = 90 g/L [no transfusion or no erythropoietin (EPO)-dependent within 7 days]; good hepatic function defined as a total bilirubin level (TBIL) of = 1.5xULN (in the presence of liver metastases , =3xULN); albumin transaminase (AST) and alanine transaminase (ALT) levels =2.5xULN (=5xULN in the presence of hepatic metastases); alkaline phosphatase =2.5xULN; and good renal function, defined as serum creatinine =1.5xULN or calculated creatinine clearance =60ml/min (Cockcroft-Gault formula) ; urine protein less than 2+ on routine urinalysis, if the patient has urine protein =2+ at baseline level 24-hour urine should be collected and demonstrated to be =1g on a 24-hour quantitative urine protein test; good coagulation function, defined as International Normalised Ratio (INR) or Prothrombin Time (PT) =1.5 times ULN; 9) Willingness and ability to comply with study-planned visits, treatment plans, laboratory tests, and other study procedures; 10) For female subjects of childbearing potential, a negative urine or serum pregnancy test should be presented within 3 days prior to receiving the first study drug administration (Cycle 1, Day 1). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. If there is a risk of conception, male and female patients will be required to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) for at least 180 days after discontinuation of trial treatment.
Exclusion criteria
Exclusion criteria: 1) Histology of squamous, small cell lung cancer or small cell lung cancer components; 2) Grade 3 to 4 immune-related adverse reactions during first-line therapy; 3) Currently participating in an interventional clinical study treatment or have been treated with another investigational drug or with an investigational device within weeks prior to the first dose; 4) Hypersensitivity to any component of the study drug; 5) Non-surgically sterilised or female patients of childbearing potential must have a negative serum HCG test within 72 hours prior to the first dose and must be non-lactating and need to agree to use appropriate contraception (e.g., intrauterine device, birth control pills or condoms, etc.) during the study treatment period and for 3 months after the end of the study treatment period; male patients agree to use appropriate method of contraception; 6) Active brain metastases; patients with asymptomatic brain metastases are eligible for enrolment; for patients with clinically suspected CNS metastases, CT or MRI examinations must be performed within 28 days prior to enrolment to exclude CNS metastases; 7) Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events within 6 months prior to screening; arrhythmias (including QTcF: =450 ms in men and =470 ms in women) requiring long-term use of anti-arrhythmic drugs and New York Heart Association classification = class II cardiac insufficiency; 8) Urine routine suggesting urinary protein =++ and confirmed 24-hour urine protein quantification >1.0 g; 9) patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; history of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease, such as ulcerative enteritis, Crohn's disease, and chronic diarrhoeal diseases, such as irritable bowel syndrome; history of tuberculosis or tuberculosis; and history of active hepatitis B, hepatitis C, and patients with HIV infection ; 10) Patients with hypersensitivity to human or murine monoclonal antibodies; 11) Those with a history of psychotropic substance abuse and unable to quit or those with mental disorders; 12) Pleural effusions or abdominal effusions with clinical symptoms requiring clinical intervention; 13) In the judgement of the investigator, a serious concomitant illness that jeopardises patient safety or interferes with the patient's ability to complete the study; 14) Other conditions that, in the judgement of the investigator, make inclusion in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressives Free Survival;Overall Survival;6-month PFS rate;6-month OS rate;12-month PFS rate;12-month OS rate;Disease Control Rate;Quality of Life; | — |
Countries
CHINA
Contacts
Public ContactKai Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed