A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy Maintenance Therapy Following Standard Chemoimmunotherapy for ES-SCLC (ALTER-L059)

Официальное название

A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy as Maintenance Therapy Following First-Line Chemoimmunotherapy in Treatment-Naïve Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ALTER-L059)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• PFS2 [Срок оценки: up to 12 months]

Вторичные конечные точки (7)

• PFS [Срок оценки: up to 12 months]
• 6-month PFS rate [Срок оценки: up to 12 months]
• 12-month PFS rate [Срок оценки: up to 12 months]
• OS [Срок оценки: From diagnosis until death (up to 24 months)]
• 6-month OS rate [Срок оценки: up to 12 months]
• 12-month OS rate [Срок оценки: up to 24 months]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

• Male or female patients aged 18 years or older;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group \[VALG\] staging criteria);
• Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;
• At least one measurable target lesion (per RECIST version 1.1 criteria);
• No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;
• ECOG performance status: 0-2;
• Life expectancy ≥3 months.

Критерии исключения

• Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;
• Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1/PD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);
• Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;
• Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;
• Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) >1.5 or activated partial thromboplastin time (APTT) >1.5 × upper limit of normal (ULN), and/or those with a bleeding tendency;
• Patients deemed by the inves.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06982287 · ALTER-L059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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