Small Cell Lung Cancer Extensive Stage
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Yong Fang
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged 18 years or older; 2. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group \[VALG\] staging criteria); 3. 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; 4. At least one measurable target lesion (per RECIST version 1.1 criteria); 5. No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC; 6. ECOG performance status: 0-2; 7. Life expectancy ≥3 months.
Exclusion criteria
1. 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; 2. 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); 3. Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen; 4. Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; 5. 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; 6. Patients deemed by the inves.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS2 | up to 12 months | Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month PFS rate | up to 12 months | Progress free survival rate at 12 months after diagnosis. |
| OS | From diagnosis until death (up to 24 months) | Overall Survival |
| 6-month OS rate | up to 12 months | Overall survival rate at 6 months after diagnosis. |
| 6-month PFS rate | up to 12 months | Progress free survival rate at 6 months after diagnosis. |
| 12-month OS rate | up to 24 months | Overall survival rate at 12 months after diagnosis. |
| Incidence of Treatment-Emergent Adverse Events | up to 24 months | Record Adverse Events (AEs) according to CTCAE (V5.0). Record and analyze the number of abnormal data. |
| PFS | up to 12 months | Progress free survival |
Outcome results
None listed