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.
Age ≥18 years, no gender restrictions;
Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a/b/c) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor/nodule size too large to be included in a tolerable radiation therapy plan;
Participants have not received systemic treatment for extensive-stage SCLC;
No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);
Participants who have previously received any T-cell co-stimulation 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 drugs.
Participants who have previously received chemoradiotherapy for limited-stage SCLC;
Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size <1cm are allowed to be included);
Participants with multiple liver metastases (isolated liver metastasis participants with metastasis <2cm can be included)
Single group
First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC
DrugCohort 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.
PFS
From the date of enrollment to the date of disease progression
OS
from the date of enrollment until death by any cause or last follow-up
Treatment-related adverse events
Treatment-related adverse events according to CTCAE 5.0.
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