Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.
Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.
Age: Males or females aged 18 to 75 years.
Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).
Stage: Stage I-III (AJCC/UICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.
Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-interventional) study.
Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).
Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.
Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.
Single group
Chemotherapy
DrugEtoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.
Immunotherapy
DrugToripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.
Angio-immuno kinase inhibitor
DrugOral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.
radiotherapy
RadiationThoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.
Prophylactic Cranial Irradiation
RadiationPCI is recommended after the completion of chemoradiotherapy.
Consolidation Therapy with Toripalimab and Surufatinib
DrugPatients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.
Median progression-free survival (PFS)
The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.
Median overall survival (OS)
The time from the start of treatment to death from any cause.
Treatment-related adverse events
The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.
Patient-Reported Outcomes
Patient reported quality of life measured by European organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) and QLQ-LC13.
Circulating Tumor DNA
The analysis of variations in ctDNA levels during and after treatment, and their correlation with patient outcomes
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