small cell lung cancer
Conditions
Interventions
Test group:Maintenance of adebelizumab+fluzopril after induction with adebelizumab+carboplatin+etoposide
Sponsors
The Third Medical Center of the General Hospital of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects should sign the informed consent form (ICF) before starting the study; 2. Age 18-75 years old, male or female; 3. Diagnosis of extensive small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage); 4. ECOG physical condition score is 0-1; 5. Subjects have not received systematic treatment for ES-SCLC in the past; 6. Subjects' weight = 30kg; 7. Patients who have received radiotherapy and chemotherapy for limited stage SCLC in the past must have received radical treatment, and there is at least 6 months' non-treatment interval from the end of chemotherapy, radiotherapy, or radiotherapy and chemotherapy to the diagnosis of extensive stage SCLC; 8. Life expectancy = 3 months; 9. Patients with a history of asymptomatic central nervous system metastasis can be enrolled only if they meet the following conditions: only supratentorial and cerebellar metastasis is allowed (that is, transfer to midbrain, pons, medulla or spinal cord is not allowed); Central nervous system diseases do not need continuous glucocorticoid treatment; No stereotactic radiation treatment within 7 days; There was no evidence of intracranial progression between the completion of CNS targeted therapy and X-ray screening study; Patients with asymptomatic CNS metastasis must receive radiotherapy and/or surgery for CNS metastasis; After treatment, these patients may qualify without need; After treatment, if all other criteria are met, these patients may not need additional brain scans before randomization. 10. There is a measurable target lesion judged according to RECIST v1.1: the lesion can be considered as a measurable lesion only when there is clear progression of the previously irradiated lesion after radiotherapy and the previously irradiated lesion is not the only one; 11. The function of main organs is normal, that is, they meet the following standards (without symptomatic treatment within 14 days): Blood routine examination: hemoglobin (Hb) = 90g/L; Platelet (PLT) = 100 × 109/L Neutrophil count (ANC) = 1.5 × 109/L ; White blood cell count (WBC) = 3.0 × 109/L Lymphocytes = 0.5 × 109/L; Biochemical examination: ALT, AST, ALP = 2.5 × ULN; ALT and AST = 5 ULN in patients with liver metastasis; Patients with liver metastasis or bone metastasis: ALP = 5 ULN; Total serum bilirubin (TBIL) = 1.5 × ULN (Gilbert syndrome subjects = 3 × ULN); Albumin (ALB) = 3 g/dL; Renal function: serum creatinine = 1.5 x ULN or creatinine clearance rate (CrCl) = 50mL/minute (using Cockcroft/Default formula); Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 1.5 × ULN; Other: lipase = 1.5 x ULN. If lipase>1.5 x ULN has no clinical or imaging confirmed pancreatitis, it can be included in the group; Doppler ultrasound evaluation: if left ventricular ejection fraction (LVEF) = 50%, the patient is eligible 12. During the study, patients must submit tumor tissue samples before treatment. Any available tumor tissue samples can be submitted. Organization samples can be submitted after enrollment. 13. Participants with impaired decision-making ability are eligible as long as their neurological or psychological status does not prevent them from participating in the study safely (for example, tracking pill consumption and reporting adverse events to the researcher) 14. Non-operatively sterilized fertile female subjec
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer (NSCLC) transformed into SCLC or SCLC patients with mixed histological types are unqualified; 2. Participants must have no history of idiopathic pulmonary fibrosis, pneumonia (including drug-induced), tissue pneumonia (such as bronchiolitis obliterans, cryptogenic tissue pneumonia, etc.), or evidence of active pneumonia in chest CT scan. A history of radiation pneumonitis with radiation part (fibrosis) is allowed. 3. No severe infection such as severe sepsis or septic shock shall occur within 14 days before enrollment, including but not limited to hospitalization due to complications such as infection, bacteremia or severe pneumonia; 4. Have received any T cell co-stimulation or immune checkpoint treatment in the past, 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. Previous use of PARP inhibitors 6. Active or new untreated CNS metastases identified by computed tomography (CT) or magnetic resonance imaging (MRI) in screening and previous radiological evaluation; 7. Spinal cord compression was not specifically treated by surgery and/or radiotherapy, or was previously diagnosed and treated, and there was no evidence that the disease had been clinically stable for 1 week before randomization; 8. Pial metastasis; 9. Patients with uncontrolled pleural effusion, pericardial effusion or ascites that need repeated drainage (once a month or more frequently) are allowed to retain catheter (such as pleural catheter); 10. Uncontrolled or symptomatic hypercalcemia (ionic calcium>1.5 mmol/L; serum calcium>12mg/dL or corrected serum calcium>ULN); 11. Patients receiving denosumab treatment before enrollment must be willing and able to stop using it in the study and replace it with bisphosphate; 12. Subjects with clinical symptoms/untreated central nervous system metastasis (such as brain and spinal cord) and leptomeningeal metastasis; In the screening period, subjects with active or new untreated CNS metastases were not included. (Unless there is no symptom, or it is stable after treatment, the imaging evidence that no new brain metastasis or expansion of brain metastasis is found at least 2 weeks after the end of treatment for brain metastasis is allowed to be included; the untreated central nervous system metastasis is allowed to be included if there is no symptom and the size of the lesion is less than 1 cm;) 13. The patient received radiotherapy for the chest and the whole brain within 4 weeks before the first dose of study drug (palliative radiotherapy for bone lesions was completed before the first dose of study drug and was allowed to be enrolled); 14. Spinal cord compression that has not been eradicated or relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression that has no clinical evidence after treatment shows that the disease is stable for = 1 week before the first medication; Active autoimmune disease requiring systemic treatment (such as the use of disease relief drugs, corticosteroids or immunosuppressants) or history of autoimmune disease and expected recurrence occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered as systemic treatment; 15. The patient was diagnosed as immune deficiency or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator assessed 6-month progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS;Overall Survival,OS;Overall Response Rate,ORR;Disease Control Rate,DCR;Duration of Response,DoR;Adverse Events,AE;Serious Adverse Event,SAE;Incidence of AE and SAE related to the study drug;Improvement of quality of life;Detection of possible biomarkers of immune resistance; | — |
Countries
China
Contacts
Public ContactZhefeng Liu
The Third Medical Center of the General Hospital of the People's Liberation Army
Outcome results
None listed