SCLC
Conditions
Interventions
Chemo group:adebrelimab + etoposide + carboplatin (D1, Q3W, 4-6 cycles) ?adebrelimab (1200mg/m2, D1, Q3W) + albumin paclitaxel (260mg/m2, D1, Q3W)
TKI group:adebrelimab + etoposide + carboplatin (D1, Q3W, 4-6 cycles) ? adebrelimab (1200mg/m2, D1, Q3W) + apatinib (250mg, qd, Q3W)
PARPi group:adebrelimab + etoposide + carboplatin (D1, Q3W, 4-6 cycles) ? adebrelimab (1200mg/m2, D1, Q3W) + flzoparib (100mg, bid, Q3W)
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male and female; 2. Extensive-stage small-cell Lung cancer confirmed histologically or cytologically according to the Veterans Administration Lung Study Group (VALG) stage; 3. ECOG performance status score 0-1; 4. No prior first-line systemic therapy or immune checkpoint inhibitor therapy for ES-SCLC; (5) Prior surgical treatment and adjuvant therapy with curative intent, such as radiotherapy and chemotherapy, and a treatment-free interval of at least 6 months from the diagnosis of extensive-stage SCLC to the last chemotherapy, radiotherapy, or chemoradiotherapy; 6. Patients with previously treated asymptomatic CNS metastases who met all the following criteria were eligible for participation in the study: supratentorial and cerebellar metastases only (i.e., no metastases to the midbrain, pons, medulla oblongata, or spinal cord); No need for continuous corticosteroid therapy for CNS disease; Imaging studies from the end of CNS-directed therapy to the time of randomization showed no progression. If new asymptomatic CNS metastases were detected on imaging during screening, patients would have to undergo radiation therapy and/or CNS metastasis surgery. After treatment, these patients did not require additional brain scans before the index dose if all other criteria were met. 7. Expected survival time >=3 months; 8. Presence of measurable lesions defined by RECIST v1.1: a lesion previously irradiated can be considered as measurable if the lesion showed definite disease progression after radiotherapy and the lesion previously irradiated is not the only lesion. 9. Women of childbearing age must have a serum pregnancy study with a negative result within 7 days before the first dose of medication. Female participants of childbearing age and male participants whose partner was a woman of childbearing age had to agree to use contraception within 24 weeks after signing the informed consent form and receiving the last dose of study drug. 10. Before the first dose of study drug, the laboratory test results met the following conditions: blood routine test (no blood transfusion or hematopoietic stimulation drug correction within 14 days before screening) : white blood cell count (WBC) =3.0 × 10^9/L; absolute neutrophil count (ANC) =1.5 × 10^9/L; platelet (PLT) =100 × 10^9/L; hemoglobin (HGB) =9.0 g/dL; Liver function: aspartate transferase (AST) =2.5 × ULN in subjects without liver metastasis; alanine aminotransferase (ALT) =2.5 × ULN, ALT and AST=5 × ULN in patients with liver metastasis; Serum total bilirubin (TBIL) =1.5 × ULN (except Gilbert's syndrome total bilirubin =3.0 mg/dL); Renal function: serum creatinine =1.5 × ULN or creatinine clearance rate (CrCl) =50 mL/minute (Cockcroft/Gault formula); 11. Coagulation function: international normalized ratio (INR) =1.5 × ULN, An activated partial thromboplastin time (APTT) of 1.5 × ULN or less (only in patients who are not currently receiving anticoagulant therapy, and those who are currently receiving anticoagulant therapy should be treated with a stable dose of anticoagulant); Others: lipase =1.5 × ULN (if lipase >1.5 × ULN without clinical or imaging evidence of pancreatitis); Amylase =1.5 × ULN (if amylase >1.5 × ULN without clinical or imaging evidence of pancreatitis); alkaline phosphatase (ALP) =2.5 × ULN, and ALP=5 × ULN in patients with liver or bone metastasis. 12. The subjects voluntarily participated in the study, signed the informed consent form, and the compliance
Exclusion criteria
Exclusion criteria: 1. Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during screening and previous imaging assessments; 2. Spinal cord compression not relieved by surgery and/or radiotherapy, or spinal cord compression previously diagnosed without clinical evidence of stable disease for at least 1 week after treatment before the first dose of medication; 3. Leptomeningeal disease; 4. Clinically symptomatic third space effusion requiring repeated drainage, such as pericardial effusion, pleural effusion and peritoneal effusion that could not be controlled by pumping or other treatments; 5. Uncontrolled or symptomatic hypercalcemia; 6. Other malignant tumors occurred within 5 years before the first dose of medication, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 7. Active, known or suspected autoimmune disease; 8. Any prior T-cell costimulation or immune checkpoint therapy; 9. Use of corticosteroids (> 10 mg/ day prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug; 10. HBsAg positive and HBV DNA copy number greater than the upper limit of normal value in the laboratory of the research center, or HCV positive; A known history of HIV positivity or known acquired immunodeficiency syndrome; 11. A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically active pneumonia; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); 12. tuberculosis (TB) or a history of active TB infection within 48 weeks or less before screening, with or without treatment; 13. Severe infection was present at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. 14. Have undergone major surgery within 28 days before the first dose of study medication or are planning to undergo major surgery during the study; 15. Use of live attenuated influenza vaccine within 28 days before the first dose of study drug or is anticipated to be required during the study (patients were not allowed to receive live attenuated influenza vaccine 4 weeks before randomization, during treatment, and within 5 months after the last dose); 16. Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction, or cerebrovascular accident within 3 months before randomization; 17. Patients with prior allogeneic bone marrow transplantation or solid organ transplantation; 18. Known allergy to the study drug or excipients; 19. Received any other trial medication or participated in another interventional clinical study within 4 weeks before signing ICF; 20. Known mental illness, alcohol abuse, inability to quit smoking, drug or substance abuse; 21. According to the investigator's judgment, the subject had other factors that may have led to the forced termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactZhengxiang Han
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed