By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.
Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.
Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L.
Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).
Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.
Histologically confirmed non-small cell lung cancer (NSCLC).
No efficacy assessment record, or missing efficacy assessment data.
Presence of other primary malignancies; history of allogeneic organ transplantation.
Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.
Patients diagnosed with small-cell lung cancer
Cohort
Prospective
radiatherapy, and chemotherapy with or without immunotherapy as clinical practice
RadiationThis is an observation study. This study adopted different timing of radio-immunotherapy combination, fractionation schedules, radiation doses, irradiation sites, PCI, and various types of immune checkpoint inhibitors.
Progression-free survival (PFS)
The time from the start of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
The time from the start of study treatment to death from any cause or the data cut-off date.
Distant Metastasis-Free Survival
the time from the date of diagnosis to the first occurrence of distant metastasis. For patients with extensive-stage small cell lung cancer (ES-SCLC) who already have distant metastasis at baseline, DMFS is defined as the time to new distant organ metastasis or new distant lesions. Patients who have not developed distant metastasis by the last follow-up are censored.
Locoregional Recurrence-Free Survival (LRFS)
The time from the date of diagnosis to the first locoregional disease progression. Patients who have not experienced locoregional events by the last follow-up are censored.
Objective Response Rate (ORR)
The percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) during the study period. The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record).
Disease Control Rate (DCR)
The percentage of patients achieving a best overall response of CR, PR, or stable disease (SD). The evaluable population includes patients with baseline imaging and at least one response assessment (or documented record).
Exploratory Endpoint
Correlation of tumor biomarkers (PD-L1, TMB, ctDNA) and peripheral blood inflammatory/immune indices (NLR, PLR, LMR, CRP, LDH, lymphocyte subsets) with antitumor activity (ORR/DCR) and survival (OS, PFS, DMFS, LRFS).
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