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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | From the date of enrollment to the date of disease progression | From enrollment to the end of treatment at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | from the date of enrollment until death by any cause or last follow-up | From date of enrollment to maximum of 2 years or death |
| Treatment-related adverse events | Treatment-related adverse events according to CTCAE 5.0. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Yu, MD | Contact | 13501147200 | 010-88121122 | yurong311@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital and Institute | Beijing | Beijing Municipality | 100142 | China |
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Treatment Protocols for the Two Cohorts drug: Adebrelimab, Carboplatin/Cisplatin, Etoposide
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| Duration of treatment and follow up until death or 90 days after enrollment |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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