Small cell lung cancer
Conditions
Interventions
Treatment group:Induction therapy:
Subjects receive induction therapy first. adebelimab 20 mg/kg, IV, Q3W + carboplatin AUC5 mg/mL·min d1 / cisplatin 75 mg/m2d1 + etoposide 100 mg/m2d1, 2, 3
Every 3 weeks is a treatment cycle
A total of 2 cycles.
Combined chemoradiotherapy:
After 2 cycles of induction therapy, adebelimab combined with chemoradiotherapy was entered (2 cycles). Adebelimab 20mg/kg, IV, Q3W+carboplatin AUC5mg/
A total of 2 cycles.
Radiation dose: 60Gy/2Gy/qd/6w.
Sponsors
Provincial Hospital Affiliated to Shandong First Medical University
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. Able to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug, or freshly obtained. The specimen needs to meet the requirements of formalin-fixed and paraffin-embedded (FFPE) tumor tissue blocks, and 7-10 sections with a thickness of 5~10µm can be cut out for staining and testing (if there are less than 7 pieces, it is necessary to negotiate with the sponsor and agree before enrollment). Specimens not subject to fine-needle biopsy, pleural effusion, drainage, and centrifugation of cell smears are not sufficient for biomarker testing; 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) >= 1.5×10^9/L, and no granulocyte colony-stimulating factor supportive therapy within 14 days before the first study treatment; Lymphocyte count (LC) >= 0.5×10^9/L; Platelet count (PLT) >= 100×10^9/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 alanineaminotransferase (ALT) = 3 g/dL; (3) Renal function: creatinine clearancerate (CrCl) >= 45mL/minute (carboplatin group); Creatinine clearance (CrCl) >= 60 mL/minute (cisplatin group) (creatinine clearance can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaborative Study formula, or the Kidney Disease Diet Improvement Formula). Urine protein = 2+, additional 24-hour urine protein quantification is required, and subjects with 24-hour urine protein quantification 50% predicted normal expiratory volume, and pulmonary carbon monoxide diffusion capacity (DLCO) or carbon monoxide diffusion factor (TLCO) > 40% predicted normal value; If the participant does not meet the above criteria, it can be treated with inhaled steroids and bronchodilators if clinically indicated, and reassessed for eligibility after 1-2 weeks; 8. Non-surgically sterilized female or male subjects of childbearing potential who agree to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive) for contraception during the study treatment period and for 3 months after the end of the study treatment period; Non-surgically sterilized female subjects of childbearing potential must have a negative serum HCG test within 7 d
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to this study if they meet any of the following conditions: 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. Malignant pleural effusion. If the subject has a pleural effusion that can be extracted during the screening period, at least one thoracentesis is required to confirm the presence of malignant tumor cells; 6. 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.; 7. 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; 8. Other malignant tumors complicated by other malignant tumors = 5 years before the first dose, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, local 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); 9. History of cardiovascular and cerebrovascular diseases of significant clinical significance, including but not limited to; (1) Congestive heart failure (NYHA classification = grade 2); (2) Unstable angina pectoris or ventricular arrhythmia requiring clinical intervention within 1 month before the first dose; (3) Myocardial infarction or cerebrovascular accident within 3 months before signing ICF; (4) left ventricular ejection fraction (LVEF) within 28 days prior to the first dose <50%; 10. Arterior/venous thrombotic events occurring within 6 months before the first study drug, such as deep vein thrombosis and pulmonary embolism; 11. 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 with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;safty; | — |
Countries
China
Contacts
Public ContactWang Caixia
Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed