small cell lung cancer
Conditions
Interventions
Test group:Adebrelimab + Etoposide + Carboplatin (4-6 cycles) ? Adebrelimab + vunakizumab
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, both male and female are eligible; 2. Widely spread small cell lung cancer confirmed by histology or cytology (according to the Veterans Administration Lung Study Group, VALG staging criteria); 3. No previous systematic treatment; 4. Patients who have received previous treatment but have no symptoms of central nervous system (CNS) metastasis, as long as they meet all the following criteria, can participate in this study: only supratentorial metastasis and cerebellar metastasis (that is, no metastasis in the midbrain, pons, medulla oblongata or spinal cord); no need to continuously use corticosteroids to treat CNS diseases; no progression was found in imaging examinations from the end of CNS-directed treatment to the time of enrollment; if new asymptomatic CNS metastasis is found in the imaging during the screening period, radiotherapy and/or surgery for CNS metastatic lesions must be performed. After treatment, if these patients meet all the other criteria, no additional brain scans are required before enrollment; 5. Expected lifespan over 3 months; 6. ECOG performance status score 0 - 1; 7. According to the RECIST 1.1 standard, at least one measurable diameter lesion is present; 8. Within one week before enrollment, the functions of important organs meet the following criteria: (1) Blood routine: white blood cell count (WBC) >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count (PLT) >= 100 × 10^9/L; hemoglobin content (HGB) >= 9.0 g/Dl; (2) Liver function: aspartate transferase (AST) = 30.0 g/L; (3) Renal function: serum creatinine = 50 mL/minute (using the Cockcroft/Gault formula); (4) Coagulation function: international normalized ratio (INR) 1.5 × ULN and there is no clinical or imaging evidence of pancreatitis, these patients can be enrolled; amylase = 1.5 × ULN. If amylase > 1.5 × ULN and there is no clinical or imaging evidence of pancreatitis, these patients can be enrolled. Alkaline phosphatase (ALP) = 50% ; 9. Pregnant women of childbearing age must undergo a serum pregnancy test 7 days before the first administration of the drug, and the result must be negative. Male subjects whose partners are pregnant women must agree to use contraception from the date of signing the informed consent form until 24 weeks after the last administration of the study drug; 10. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. During the screening period and based on previous imaging evaluations, active or untreated CNS metastatic lesions were detected through computed tomography (CT) or magnetic resonance imaging (MRI); 2. Meningeal diseases; 3. Presence of uncontrollable massive pleural effusion, pericardial effusion or ascites; 4. Existing cardiac disorders: (1) According to the NYHA cardiac function classification, cardiac function at levels III-IV (2) Unstable angina pectoris or electrocardiogram indicating acute ischemia or having experienced myocardial infarction within 1 year (3) Abnormal conduction system disorders with clinical significance (including QTc interval for males greater than or equal to 450ms and for females greater than or equal to 470ms) (4) Clinical significance of pericardial and myocardial diseases; 5. Insufficient bone marrow reserve or organ function; 6. Use of systemic immunomodulatory agents (including but not limited to thymosin, interferon or interleukin-2) within 4 weeks prior to enrollment; 7. Use of corticosteroid hormones (> 10 mg/day prednisone or equivalent dose) or other immunosuppressants within 2 weeks prior to enrollment; 8. Any active autoimmune diseases or autoimmune disease history; interstitial pneumonia, drug-induced pneumonia, steroid-treated radiation pneumonia or clinically symptomatic active pneumonia; 9. Active or uncontrolled severe infection within 2 weeks prior to enrollment (CTCAE 5.0 >= 2 grade), and/or having received antibiotic treatment; 10. Active or undergoing treatment for pulmonary tuberculosis patients; 11. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg), having a history of hypertensive crisis or hypertensive encephalopathy; 12. Having experienced a thromboembolic event (such as cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, or other clinically symptomatic thromboembolic events within 24 weeks prior to enrollment; 13. Having undergone invasive surgery within 4 weeks prior to enrollment; 14. HBsAg positive and HBV DNA test value exceeding the upper limit of the normal reference range (1000 copies/mL or 100 IU/mL), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection), or history of HIV positive; 15. Having received live vaccines within 12 weeks prior to enrollment; 16. Known to be allergic to the study drug or excipients, known to have a severe allergic reaction to any monoclonal antibody; 17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Having concurrent other malignant tumors within 5 years prior to enrollment, except for fully treatable cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, locally advanced prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 19. Known to have severe mental disorders, alcoholism, drug abuse or drug addiction; 20. Having received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF; 21. As determined by the investigator, the subject has other factors that may lead to the study being prematurely terminated, such as non-compliance with the protocol, other severe diseases (including mental disorders) requiring combined treatment, severe laboratory abnormalities, and fa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rates of maintenance period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival period;Overall survival period;Objective response rate;Disease control rate;Duration of relief;Safety; | — |
Countries
China
Contacts
Public ContactLiang Chen / Qingqing Ding
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed