A Phase 2 interventional study of First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC in SCLC, Extensive Stage, Immunotherapy and Chemotherapy, sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.
Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hemoglobin (Hb) ≥90g/L; Platelet (PLT) ≥100×10\^9/L; Neutrophil count (ANC) ≥1.5×10\^9/L; White blood cell count (WBC) ≥3.0×10\^9/L;
Lymphocyte ≥0.5×10\^9/L; b) Biochemistry:
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g/dL;
Renal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL/minute (using Cockcroft/Gault formula); c) Coagulation:
Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase >1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
Exclusion Criteria:
After three cycles of induction therapy with atezolizumab combined with carboplatin/cisplatin plus etoposide, patients who do not show progression will undergo immune-concurrent chemoradiotherapy and immune-sequential chemoradiotherapy, followed by maintenance therapy with atezolizumab until disease progression.
Drug: First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC
Cohort 1: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Concurrent Radiotherapy Phase: the fourth cycle will incorporate concurrent radiotherapy along with atezolizumab and chemotherapy. Maintenance Phase: Atezolizumab monotherapy will be administered until disease progression or intolerance by the patient, with atezolizumab being administered for a maximum duration of 2 years. Cohort 2: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Sequential Radiotherapy Phase: the fourth cycle will receive sequential radiotherapy in combination with atezolizumab.Final,Atezolizumab monotherapy will be continued until disease progression.
Also known as: Adebrelimab
PFS
From the date of enrollment to the date of disease progression
Time frame: From enrollment to the end of treatment at 1 year
OS
from the date of enrollment until death by any cause or last follow-up
Time frame: From date of enrollment to maximum of 2 years or death
Treatment-related adverse events
Treatment-related adverse events according to CTCAE 5.0.
Time frame: Duration of treatment and follow up until death or 90 days after enrollment
Plan to share: Yes
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Peking University Cancer Hospital & Institute