Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Adebrelimab combined with chemotherapy synchronous LDRT
Chemotherapy
low dose radiotherapy
West China Hospital of Sichuan University
Sichuan, China
RECRUITINGoverall survival
Time from randomization to death from any cause. Unit of measure: median overall survival (months); hazard ratio (HR) and 95% confidence interval (CI); 12- and 24-month survival rates (%). Assessment schedule: survival status assessed every 3 months after the end of treatment until death or study cut-off (up to 36 months).
Time frame: From date of randomization to the time when the subject died from any cause, up to approximately 36 months
Progression free survival
Time from randomization to the earliest of radiologically documented progressive disease (per RECIST 1.1 assessed by the investigator) or death from any cause. Unit of measure: median progression-free survival (months); hazard ratio (HR) and 95% confidence interval (CI); 6- and 12-month PFS rate (%). Measurement tool: contrast-enhanced CT or MRI scanned every 6 weeks for the first 48 weeks, then every 12 weeks until disease progression, death, or study cut-off.
Time frame: From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.
Time to second progression or death (PFS2)
Defined as time from randomization to the earliest of radiologically documented second progression (per RECIST 1.1 assessed by the investigator ) or death from any cause. Unit of measure: median PFS2 (months); hazard ratio (HR) and 95% CI; 6- and 12-month PFS2 rate (%). Measurement tool: contrast-enhanced CT/MRI. Assessment schedule: imaging every 6 weeks during induction; every 4-6 weeks during maintenance; after first PD, every 6 weeks until second PD or death.
Time frame: From date of randomization to the date of second documented progression or death from any cause, whichever occurs first, assessed up to 36 months
Disease control rate
Proportion of randomized subjects with best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months.
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Time frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first.
Overall response rate (ORR)
Proportion of randomized subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks (±7 days) for the first 48 weeks, then every 12 weeks (±7 days) until progression, death, or 36 months; response determined by site investigator.
Time frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first
Duration of response (DoR)
Time from first documented complete response (CR) or partial response (PR) per RECIST 1.1 (investigator assessment) until the date of documented progressive disease or death from any cause, whichever occurs first. Unit of measure: median duration of response (months); 95% confidence interval of the median; 6- and 12-month response duration rate (%) Assessment schedule: imaging every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months.
Time frame: From the date of first CR/PR to the date of documented progression or death from any cause, assessed up to 36 months
Depth of Response
Maximum percentage reduction in the sum of longest diameters of target lesions relative to baseline per RECIST 1.1 assessed by the investigator. Unit of measure: median percentage change (%); inter-quartile range (IQR); Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months; tumor diameters measured by the site investigator.
Time frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first.
Post-progression survival (PPS)
Time from the date of first documented progressive disease (per RECIST 1.1, investigator assessment) to the date of death from any cause. Unit of measure: median post-progression survival (months); hazard ratio (HR) and 95% confidence interval; 6- and 12-month survival rate (%). Assessment schedule: survival status contacted every 3 months after progression until death, lost to follow-up, or study cut-off.
Time frame: From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression.
Incidence and severity of adverse events (AEs)
Number and percentage of participants experiencing AEs graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%); number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug; assessed at every study visit (baseline, weekly during cycle 1, then day 1 of each subsequent cycle, and at follow-up).
Time frame: Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases (to 90 days after the last dose of drug).
Incidence of serious adverse events (SAEs)
Number and percentage of participants experiencing serious adverse events (SAE) graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%) of subjects with ≥1 SAE; number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug. All SAEs reported within 24h of awareness.
Time frame: Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases(before 2nd PD and 3 month afterwords).