Clinical trial · Observational
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Experimental Group
- description
- patients treated with anlotinib Hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy.
Primary outcomes (1)
- measure
- PFS2
- timeFrame
- up to 12 months
- description
- Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.
Secondary outcomes (7)
- measure
- PFS
- timeFrame
- up to 12 months
- description
- Progress free survival
- measure
- 6-month PFS rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available