Neuroendocrine tumor
Conditions
Interventions
Subtype 1/2/3:Induction Phase:
Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the
Sponsors
Beijing Chest Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, gender is not limited; 2. Pathologic diagnosis of unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, carcinoid cancer). Among them, carcinoid is an atypical carcinoid patient who is judged by the investigator to be asymptomatic and the tumor continues to grow and requires systemic treatment; 3. No prior systemic anti-tumor therapy; 4. Life expectancy of at least 3 months; 5. ECOG score: 0-2 points; 6. Have an evaluable lesion on imaging, and according to the Efficacy Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one measurable tumor lesion (non-lymph node lesion with the longest diameter of = 10mm in the baseline stage, or lymph node lesion with a short diameter of >=15mm); 7. For patients with brain metastases, asymptomatic or symptomatic patients with stable brain metastases are required to be enrolled; 8. Normal function of major organs, i.e. meeting the following criteria: (1) The criteria for routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): a. Hemoglobin (Hb) >=90 g/L; Neutrophil count (ANC) > = 1.5×10^9/L; c. Platelet count (PLT) > = 100×10^9/L; d. White blood cell count (WBC) >=3.0×10^9/L; (2) Biochemical examination shall meet the following standards: a. Serum total bilirubin (TBIL) 50 ml/min (Cockcroft-Gault formula); d. Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) 1.5 x ULN without clinically or radiographically confirmed pancreatitis can be enrolled; 9. Women of childbearing potential must have taken reliable contraceptive measures or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result; Males and females of gestational age must agree to use adequate contraception throughout the study and for 6 months after the end of treatment; 10. Subjects voluntarily join this study, and sign the informed consent form, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Subject has extensive meningeal metastases or active brain metastases with significant symptoms; 2. Spinal cord compression that has not been definitively treated with surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression, and there is no evidence that the disease has been clinically stable for 1 week prior to randomization; 3. Uncontrolled or symptomatic hypercalcemia; 4. Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other drugs targeting T cells; 5. Use of immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 14 days prior to the first dose of adebelimab, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisolone or equivalent pharmacophysiological doses of other corticosteroids); 6. Have active tuberculosis (TB) or have a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated or not. 7. Vaccinated or planned to receive a preventive vaccine or live attenuated vaccine within 4 weeks before the first dose; 8. Have a history of allogeneic bone marrow transplantation or solid organ transplantation; 9. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II., poorly controlled arrhythmia (including QTc interval > = 450 ms for males and > = 470 ms for females); Grade III.~IV cardiac insufficiency (according to the New York Cardiology Association NYHA classification, see Annex 3), or cardiac color ultrasound showed left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the premise of the international normalized ratio (INR) of prothrombin time < = 1.5, low-dose heparin (0600~12000 U per day for adults) or low-dose aspirin (daily dosage <= 100 mg) or low-dose warfarin (1 mg orally, once daily) is allowed for prophylactic purposes; 13. Major surgical surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to enrollment, or planned major surgery during the study; 14. Severe infections such as severe sepsis or septic shock must not occur within 14 days prior to enrollment, including but not limited to hospitalization for complications such as infection, bacteremia or severe pneumonia; 15. Clinically significant hemoptysis or hemoptysis gre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month PFS rate (Progression-Free Survival rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival;AE; | — |
Countries
China
Contacts
Public ContactTongmei Zhang
Beijing Chest Hospital of Capital Medical University
Outcome results
None listed