small cell lung cancer
Conditions
Interventions
A:Adbelimumab: Intravenous infusion, fixed dose 1200mg, infusion should be completed within 30 to 60 minutes, once every 3 weeks. Irinotecan liposomes: Intravenous infusion, 100 mg/m2, 90 minutes, onc
B:Adbelimumab: Intravenous infusion, fixed dose 1200mg, infusion should be completed within 30 to 60 minutes, once every 3 weeks. Irinotecan liposomes: Intravenous infusion, 100 mg/m2, 90 minutes, onc
C:Adbelimumab: Intravenous infusion, fixed dose 1200mg, infusion should be completed within 30 to 60 minutes, once every 3 weeks. Until the disease progresses and/or an intolerable toxic reaction occu
EP regimen: etoposide l00mg/m2 intravenous infusion 1~3 days, cisplatin 75mg/m2 intravenous infusion
Or EC regimen: etoposide l00mg/m2 intravenous infusion day 1 to 3, carboplatin AUC=5 to 6 intravenous infusion
For other platinum types, the dosage should be taken according to the clinical medication guidance of the corresponding product (the regimen should be selected according to the front-line treatment re
Sponsors
Shijiazhuang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All subjects are required to sign the Inform consent form (ICF) before starting the study related procedures. 2. =18 years old and =70 years old 3. Histologically or cytologically proven SCLC 4. The stage was ES-SCLC according to the Veterans Administration Lung Study Group (VALG) 5. Previous first-line platinum-based treatment for ES-SCLC, and objective imaging progress (as determined by RECIST 1.1 criteria). Includes: • Progress =180 days from the last chemotherapy • Sensitive recurrence: = 90 days from the last chemotherapy and < 180 days from progression • Drug resistance relapse: distance from the last chemotherapy < 90-day progress 6.ECOG PS 0 to 1 points 7. Expected survival =12 weeks 8. CT or MRI scan showing at least one previously untreated target lesion =28 days before the first dose of the investigational drug (RECIST v1.1) 9. Fertile female subjects must have a negative blood pregnancy test within 72 hours before the first dose, are not breastfeeding, and must agree to use effective contraception during the trial period and 2 months after the last dose of adabiliumab or 6 months after the last dose of chemotherapy drugs, whichever is longer; Male subjects whose partners are fertile women should be surgically sterilized or agree to use effective contraception during the trial period and 2 months after the last administration of adbelizumab or 3 months after the last administration of chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study period 10. Before the first dose of the investigational drug, the laboratory test value meets the following conditions: (1) blood routine: white blood cell (WBC) =3.0 × 10^9/L; absolute neutrophil count (ANC) =1.5 × 10^9/L; platelet (PLT) =100 × 10^9/L; hemoglobin content (HGB) =9.0 g/dL (2) Liver function: Subjects without liver metastasis aspartate transferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN, alkaline phosphatase (ALP) = 2.5×ULN (upper limit of normal); ALT and AST< in subjects with liver metastasis; 5 x ULN; Patients with liver or bone metastasis: ALP =5 ULN; Serum total bilirubin (TBIL) =1.5 x ULN (except Gilbert syndrome total bilirubin < 3.0 mg/dL); albumin (ALB) =3 g/dL (3) Renal function: serum creatinine =1.5 x ULN or creatinine clearance rate (CrCl) =50 mL/minute (using Cockcroft/Gault formula); urine protein (UPRO) negative (4) Coagulation function: international normalized ratio (INR) =1.5, activated partial thromboplastin time (APTT) =1.5 x ULN (5) Other: amylase = 1.5x ULN. If amylase; 1.5 x ULN without clinical or radiological evidence of pancreatitis could be enrolled
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to the study if they: 1. Histologically or cytologically confirmed mixed SCLC with NSCLC 2. Previously received anti-tumor virus therapy. Prior treatment with any T cell co-stimulation or immune checkpoint, 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 that target T cells 3. Previous treatment with topotecan, irinotecan, or other topoisomerase I inhibitors 4. There are clinical symptoms/untreated brain or meningeal metastases. Treated subjects with BMS were required to meet the following criteria to be enrolled: • No MR-demonstrated progression =4 weeks after completion of treatment • Completion of treatment =28 days before the first dose of the study drug • Systemic corticosteroid therapy (> 10mg/ day prednisone or equivalent) is not required for =14 days prior to the first dose of the study drug 5. Radiotherapy for the chest and the whole brain should be completed 10 mg/ day prednisone or equivalent dose) or other immunosuppressants within =14 days prior to the first dose of the study drug. Inhaled or topical use of steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease 10. Subjects who have received or plan to receive live vaccine within =4 weeks prior to the initial study drug (Note: injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days of the first dose; However, live attenuated vaccines for intranasal use are not allowed) 11. interstitial pneumonia (ILD), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or active pneumonia with clinical symptoms 12. Subjects with active tuberculosis (TB) or a history of active tuberculosis infection within 48 weeks or less before screening, with or without treatment 13. Except for alopecia and fatigue, other toxicities due to previous antitumor therapy should be restored to CTCAE 4.03= grade 1 before the first dose of study medication. Other toxicities due to previous antitumor therapy that are not expected to resolve and have long-lasting sequelae, such as neurotoxicity due to platinum-based therapy, are allowed to be included 14. Minor surgery (including catheterization) within 48 hours before first receiving the investigational drug 15. Current or recent use (within 10 days before receiving the first dose of the study drug) of aspirin (> 325 mg/ day) or other NSaids known to inhibit platelet function 16. Current or recent (within 10 days before receiving the first dose of the study drug) treatment with a full dose of oral or parenteral anticoagulants or thrombolytic agents. But prophylactic use of anticoagulants is permitted 17. Hereditary b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;progression free survival, PFS;duration of response, DoR;disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactZhang Yan
Shijiazhuang People's Hospital
Outcome results
None listed