Adebrelimab + Apatinib in SCLC Maintenance Therapy
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollmen
| Condition(s) | SCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression. |
| Who can participate | Inclusion Criteria: 1. Voluntary participation with signed informed consent and good compliance for follow-up. 2. Age between 18 and 75 years old. 3. Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria. 4. ECOG performance status score: 0 to 2. 5. Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy. 6. Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy. 7. Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks. 8. At least one measurable lesion |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Tang-Du Hospital |
| Locations | Xi'an, Shannxi, China |
| Start date | 2024-06-20 |
| NCT ID | NCT06475209 |
| Official listing | https://clinicaltrials.gov/study/NCT06475209 |