About this trial
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.
Eligibility criteria
Qualifiers
Voluntary participation with signed informed consent and good compliance for follow-up.
Age between 18 and 75 years old.
Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.
ECOG performance status score: 0 to 2.
Disqualifiers
Limited-stage small cell lung cancer (SCLC).
Histologically or cytologically confirmed mixed-type SCLC.
Prior use of anti-angiogenic drugs or deemed unsuitable for anti-angiogenic therapy by the investigator.
Central tumors invading major blood vessels with assessed bleeding risks.
Trial design
Treatments tested in this trial
- Adebrelimab combined with Apatinib
Treatment groups
Sponsors and collaborators
Tang-Du Hospital
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator