This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS),overall survival (OS) , and safety.
This multicenter study seeks to retrospectively analyze medical records (January 2022-December 2024) of extensive-stage small cell lung cancer (ES-SCLC) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. Key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. Eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. The primary objectives are to assess the clinical effectiveness and safety of this combination strategy in ES-SCLC.
Study Type
OBSERVATIONAL
Enrollment
100
PFS2
Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.
Time frame: up to 12 months
PFS
Progress free survival
Time frame: up to 12 months
6-month PFS rate
Progress free survival rate at 6 months after diagnosis.
Time frame: up to 12 months
12-month PFS rate
Progress free survival rate at 12 months after diagnosis.
Time frame: up to 12 months
OS
Overall Survival
Time frame: From diagnosis until death (up to 24 months)
6-month OS rate
Overall survival rate at 6 months after diagnosis.
Time frame: up to 12 months
12-month OS rate
Overall survival rate at 12 months after diagnosis.
Time frame: up to 24 months
Incidence of Treatment-Emergent Adverse Events
Record Adverse Events (AEs) according to CTCAE (V5.0). Record and analyze the number of abnormal data.
Time frame: up to 24 months
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