Small cell lung cancer
Conditions
Interventions
Treatment group:Immunotherapy combined with chemotherapy begins in Week 1, concurrent with stereotactic body radiation therapy (SBRT). After 4–6 cycles of combined therapy, immunotherapy monotherapy i
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no gender restriction; 2. Primary lesion is peripheral-type lung cancer; 3. Pathologically confirmed extensive-stage small cell lung cancer (SCLC); 4. Subject has not received prior systemic therapy for extensive-stage SCLC; 5. At least one measurable lesion present (per RECIST v1.1); 6. ECOG performance status score of 0-2; 7. Life expectancy >= 3 months; 8. Informed consent obtained and signed, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other trial procedures; 9. Normal major organ function, meeting the following criteria (without symptomatic treatment within the past 14 days): a) Complete blood count: Hemoglobin (Hb) >= 90 g/L; Platelet count (PLT) >= 100 × 10?/L; Absolute neutrophil count (ANC) >= 1.5 × 10?/L; White blood cell count (WBC) >= 3.0 × 10?/L; Lymphocyte count >= 0.5 × 10?/L; b) Biochemical tests: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =3 g/dL; Renal function: Serum creatinine =50 mL/minute (using Cockcroft/Gault formula); c) Coagulation function: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin time (PT) 1.5×ULN may be enrolled if no clinically or radiologically confirmed pancreatitis is present; e) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=50% 10. Female subjects of childbearing potential must have a negative serum HCG test within 72 hours prior to first dosing and must not be breastfeeding. They must use a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 2 months after the last dose of adebelimab or 6 months after the last dose of carboplatin/etoposide. etoposide (whichever is longer). Male subjects with female partners of reproductive potential must be surgically sterilized or agree to use highly effective contraception during the study and for 2 months after the last dose of adebelimab or 3 months after the last dose of carboplatin/etoposide (whichever is longer). Sperm donation is not permitted during the study.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any T-cell co-stimulatory or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other T-cell-targeted agents. 2. Subjects with clinically symptomatic central nervous system (CNS) metastases (e.g., brain, spinal cord) or leptomeningeal metastases; subjects with active or new CNS lesions identified on screening imaging will be excluded. (Untreated CNS metastases are permissible if asymptomatic and 90%, such as basal cell or squamous cell skin carcinoma, cervical carcinoma in situ, localized prostate cancer following radical prostatectomy, localized bladder cancer, ductal carcinoma in situ following radical cystectomy, or carcinoma in situ of the breast); 12. Subjects with any severe and/or uncontrolled medical conditions, including: a) Uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); history of hypertensive crisis or hypertensive encephalopathy; b) Uncontrolled cardiac symptoms or conditions such as: >= Grade 2 myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including male QTc >= 450 ms or female QTc >= 470 ms), and >= Grade 2 congestive heart failure (New York Heart Association [NYHA] classification), unstable angina, myocardial infarction within 24 weeks, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention); c) Active or uncontrolled severe infection (>= CTC AE Grade 2 infection), including but not limited to hospitalization for infection complications, bacteremia, or severe pneumonia, or unexplained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS ; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;overall response rate, ORR;disease control rate, DCR;adverse event, AE; | — |
Countries
China
Contacts
Public ContactZhouguang Hui
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed