Small cell lung cancer
Conditions
Interventions
test group:Induction therapy:
adebelimab 1200mg, IV, Q3W+carboplatin AUC5, d1, etoposide 100mg/m2 d1-3
2 cycles.
thoracic radiotherapy:
After the end of induction therapy, the treatment regimen was carboplatin AUC5, D1 + etoposide 100mg/m2 d1-3 + chest radiotherapy (the radiotherapy mode is determined
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following enrollment criteria to be eligible for admission to this study: 1. Age 18-75 years old (both ends), male and female; 2. Histologically confirmed limited-stage small cell lung cancer that has not undergone systemic antineoplastic therapy (defined as stage I-III according to the American Joint Committee on Cancer 8th edition, all lesions can be included in a tolerable radiation therapy plan); 3. ECOG physical fitness status score 0~1 points; 4. Presence of at least one measurable lesion as defined by RECIST criteria v1.1; 5. Lung function: Check the forced expiratory volume in 1 second (FEV1) > 70% predicted value 6. Adequate hematologic and end-organ function as defined by laboratory test results as defined below by laboratory test results within 7 days prior to the first dose of study treatment: (1) Routine blood count: absolute neutrophil count (ANC) = 1.5×109/L, and no granulocyte colony-stimulating factor supportive therapy within 14 days before the first study treatment; Platelet count (PLT) = 100×109/L, hemoglobin (Hb) = 90g/L, and no blood transfusion within 14 days prior to the first dose of study treatment; (2) Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT) =3 x ULN; serum total bilirubin (TBIL) =1.5 x ULN (=3.0 mg/dL in patients with confirmed Gilbert syndrome); albumin (ALB) =3 g/dL; (3) Renal function: serum creatinine =1.5 x ULN or creatinine clearance rate (CrCl) =50 mL/minute (creatinine clearance can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Cooperative Research Formula, or the Kidney Disease Diet Improvement Formula). Urine protein < 2+ (if urine protein = 2+, additional 24-hour urine protein quantification is required, and subjects with 24-hour urine protein quantification <1g can be enrolled in the study); (4) Coagulation function: international normalized ratio (INR) = 1.5, activated partial thromboplastin time (APTT) = 1.5 x ULN; (5) Cardiac color ultrasound examination: left ventricular ejection fraction (LVEF) =50%; 7. Non-surgically sterilized female or male subjects of childbearing potential who agree to use at least one medically approved form of contraception (such as intrauterine segments) during study treatment and for 3 months after the end of the study treatment period
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed mixed SCLC or NSCLC; 2. Previous anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors; If you have received anti-tumor treatment with proprietary Chinese medicine in the past, the interval between the end of traditional Chinese medicine treatment and the first study medication shall not be less than 2 weeks 3. Extensive-stage SCLC; 4. Operable SCLC (clinical stage T1-2N0, except for those who have surgical contraindications or refuse surgery); 5. Subjects with known or suspected interstitial pneumonia; Other moderate-to-severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function. These include, for example, idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc.; 6. Active, known or suspected autoimmune disease and history of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, inflammatory bowel disease, etc. Type I diabetes mellitus (controlled by insulin therapy for blood glucose), residual hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy alone, or conditions that are not expected to recur in the absence of external stimulation are allowed to be enrolled; Patients with eczema, psoriasis, lichen simplex chronicus, or only manifestations of vitiligo dermatosis (psoriatic arthritis should be excluded) if the rash covers less than 10% of body surface area, has adequately controlled disease at baseline and requires only low-potency topical steroid therapy, and has not had an acute exacerbation of underlying disease in the past 12 months (no psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids) can be entered into the study; 7. Other malignant tumors complicated by other malignant tumors = 5 years before the first dose, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed); 8. History of cardiovascular disease of significant clinical significance, including but not limited to; (1) congestive heart failure (NYHA classification > 2); (2) unstable angina; (3) Myocardial infarction within 3 months prior to signing ICF; (4) Any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; 9. Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; Active infection of CTCAE=2 grade 2 requiring treatment with systemic antibiotics within 2 weeks prior to the first dose; 10. Those who have active pulmonary tuberculosis infection within 1 year before enrollment through medical history or CT examination, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated; 11. History of immunodeficiency, including positive HIV serological test; 12. Patients with active hepatitis B or C. HBsAg or HBcAb-positive patients who have an HBV DNA test that is less than the upper limit of normal at their site can participate in this study. HCV antibody-positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;duration of response;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactZhou Mi
Qingdao Municipal Hospital
Outcome results
None listed