small cell lung cancer
Conditions
Interventions
Experimental group:Adbelimab+chemotherapy+ivarmacitinib
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old, male or female; 2. ECOG score: 0-1 point; 3. Extensive-stage small cell lung cancer confirmed by histology or cytology (International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria or VALG stage II staging); 4. Have not received systematic treatment in the past; 5. Prior to enrollment, imaging assessment (enhanced CT or MRI) should include at least one measurable target lesion (RECIST 1.1); 6. Asymptomatic or treated stable patients with central nervous system (CNS) metastases must meet the following conditions: (1)At least 4 weeks after the end of treatment without imaging progression; (2)Complete treatment 4 weeks before enrollment; (3)Within 2 weeks prior to enrollment, there is no need to receive systemic corticosteroid therapy (>10mg/day prednisone or other equivalent doses); 7. Expected survival period >= 12 weeks; 8. All participants are required to sign an Informed Consent Form (ICF) before commencing any relevant procedures in the study; 9. Within one week before enrollment, the important organ function meets the following criteria (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors): (1) Blood routine: White blood cell count WBC >= 3.0 × 10^9/L; Absolute neutrophil count ANC >= 1.5 × 10^9/L; Platelet PLT >= 100 × 10^9/L; Hemoglobin content HGB >= 90g/L; (2) Liver function: Aspartate aminotransferase AST = 30.0g/L; (3) Renal function: serum creatinine = 50 mL/minute (using Cockcroft/Gault formula); (4) Coagulation function: International standardized ratio INR 1.5 × ULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the study; Starch enzyme 1.5 × ULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the study. Alkaline phosphatase ALP = 50%. 10. Female subjects with fertility must have a negative serum HCG test within 7 days before their first medication, and must be non lactating. They must agree to use effective contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and 3 months after the last administration of adebelimab and ivarmacitinib, or 6 months after the last administration of platinum based drugs (whichever is longer); For male participants whose partners are fertile women, surgical sterilization or agreement to use effective contraception methods during the study treatment period and within 3 months after the last administration of adebelimab and ivarmacitinib (whichever is longer) is required. Sperm donation is not allowed during the study period.
Exclusion criteria
Exclusion criteria: 1. Organizational or cellular pathological diagnosis of NSCLC patients or mixed SCLC and NSCLC patients; 2. Previously received extensive systemic treatment for SCLC; 3. Radiotherapy for the chest and whole brain should be completed within 4 weeks before enrollment (palliative radiotherapy for bone lesions is allowed to be included before the first dose of the study drug); 4. Except for hair loss and fatigue, other toxicities caused by previous anti-tumor treatments did not recover to CTCAE 5.0 = 4 weeks after the end of treatment, and completion of treatment within >= 28 days before the first dose of the study drug; Systemic corticosteroid therapy (>10mg/day prednisone or equivalent dose) is not required for = 450ms for males and >= 470ms for females); (4) clinically significant pericardial and myocardial diseases; 10. Used systemic immune modulators (including but not limited to thymosin, interferon, or interleukin-2) within 4 weeks prior to enrollment; 11. Have any active autoimmune disease or history of autoimmune disease; Interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid treatment (greater than 10mg/day prednisone or its equivalent dose), or clinically symptomatic active pneumonia; 12. Active or uncontrolled severe infection (CTCAE 5.0 >= 2) and/or antibiotic treatment within 2 weeks prior to enrollment; 13. Active or under treatment tuberculosis patients; 14. People with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA = 500 IU/ml and abnormal liver function), hepatitis C (hepatitis C antibody positive, HCV-RNA higher than the detection limit of the analytical method and abnormal liver function) or co infection of hepatitis B and hepatitis C; 15.Uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg), history of hypertensive crisis or hypertensive encephalopathy; 16.Within the 12 weeks prior to signing the ICF, there has been an arterial/venous thrombosis event, such as a cerebrovascular accident (in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS;Overall Survival,OS;Objective Response Rate,ORR;Duration of Response,DoR;Disease Control Rate,DCR;Safety; | — |
Countries
China
Contacts
Public ContactYutao Liu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed