small cell lung cancer
Conditions
Interventions
Test group:Adabelimab: 20mg/kg, intravenous drip, d1,q3w
Chemotherapy regimen: EP etoposide 100mg/m2, intravenous d1-3,
cisplatin 75mg/m2, intravenous d1, q3w
EC etoposide 100mg/m2, intravenous d1-3, carboplatin AUC= 5~6, intravenous d1, q3w
Preoperative treatment with Adabelimab combined with chemotherapy regimen for 3-4 cycles
Sponsors
The Second Hospital & Clinical Medical School. Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 75 years old; 2. ECOG (Eastern Cooperative Oncology Group) PS (Physical Fitness Status): 0-1 points; 3. Diagnosed with localized small cell lung cancer through histopathology; According to the 8th edition TNM staging, stages IIB-III. 4. There are measurable lesions that meet the RECIST 1.1 criteria; 5. Expected survival period >= 3 months; 6. Having sufficient organ and bone marrow function, defined as follows: Neutrophil count (ANC) >= 1.8 × 10^9/L; Platelet count (PLT) >= 80 × 10^9/L; Hemoglobin (Hb) >= 90 g/L; Serum creatinine = 50 ml/min; Total bilirubin (BIL) <= 1.5 times the upper limit of normal (ULN); AST/SGOT or ALT/SGPT levels <= 2.5 times the upper limit of normal (ULN); 7. Thyroid function indicators: FT3, FT4, TSH normal or abnormal have no clinical significance; 8. Female participants of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result must be negative. They must also be willing to use a medically recognized and effective contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study period and within 3 months after the last administration of the study medication; For male participants whose partners are women of childbearing age, surgical sterilization should be performed, or they should agree to use effective contraception methods during the study period and within 6 months after the last study administration; 9. With my consent and signed informed consent form, I have good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with malignant tumors other than small cell lung cancer within 5 years before the first administration (excluding non melanoma skin cancer and the following in situ cancers); Unless complete remission has been achieved at least 2 years prior to enrollment in the study and no other treatment has been administered and is not required during the study period; 2. Untreated central nervous system (CNS) metastasis; In addition, subjects who receive stable or gradually decreasing doses of = 2000 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; 6. Within 14 days prior to the first use of the investigational drug, have used immunosuppressive drugs (i.e. not exceeding 10 mg/day of prednisone or its equivalent); 7. Vaccination with attenuated live vaccine within 4 weeks prior to the first administration or planned during the study period; 8. There is evidence of past or current pulmonary fibrosis, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe impairment of lung function; 9. Uncontrollable hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal drug treatment); 10. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450ms in males and >= 470ms in females). According to NYHA standards, patients with grade III-IV heart failure, or those with left ventricular ejection fraction (LVEF)38.5 ° C during screening/before the first administration; 12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response ,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission, MPR;Objective response rate, ORR;Disease free survival, DFS;Overall survival, OS;Progression-free survival, PFS;safety; | — |
Countries
China
Contacts
Public ContactSong Tieniu
The Second Hospital & Clinical Medical School. Lanzhou University
Outcome results
None listed