Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy
ConditionSCLC,Extensive Stage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules 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 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. 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
This trial does not accept healthy volunteersQualifiers
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 (ES-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 histology SCLC;
Prior treatment with anti-angiogenic agents;
Conditions that may affect oral drug intake, such as inability to swallow, chronic diarrhea, or intestinal obstruction;
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab combined with Etoposide Capsules
DrugEach treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Etoposide Capsules is given orally at a dosage of 50mg or 25mg daily, day 1 to 14 of a 21-day cycle. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Time frame
Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 yearsSecondary outcomes
1
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Time frame
The maximum time from receiving treatment to dying for any reason is 4 years.2
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Time frame
Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.3
Duration of Response
Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death.
Time frame
Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years.Sponsors and contacts
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Source ClinicalTrials.gov