This is a multicenter, single-arm, exploratory clinical study designed to observe and evaluate the efficacy and safety of adebrelimab combined with oral etoposide for elderly patients and patients with poor performance status in small cell lung cancer.
This is a multicenter, single-arm, exploratory clinical study planned to enroll 47 patients, aiming to evaluate the efficacy and safety of adebrelimab combined with oral etoposide for elderly patients and patients with poor performance status in small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Adebrelimab: 1200 mg, administered by intravenous infusion, once every 3 weeks, repeated until disease progression, unacceptable toxicity, or the patient has received a cumulative total of 2 years of adebrelimab treatment.
Oral etoposide soft capsules: 75 mg, days 1-14, orally once daily, administered for 2 weeks followed by 1 week off.
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Progression-Free-Survival
Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: up to 24 months
Objective Response Rate
Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time frame: up to 24 months
Disease control rate
Disease Control Rate (DCR) is defined as the proportion of evaluable patients who achieve either an objective response (Complete or Partial Response) or maintain Stable Disease following a therapeutic intervention.
Time frame: up to 24 months
Overall Survival
Defined as the time from randomization to death from any cause.
Time frame: up to 24 months
Safety: Incidence of adverse events
Incidence of adverse events
Time frame: up to 24 months
Patient-Reported Outcomes (PROs)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (Version 3.0)
Time frame: Up to 24 months
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