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)

ConditionSmall Cell Lung Cancer Extensive Stage

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSichuan University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged 18 to 75 years, regardless of gender;

ECOG Performance Status (PS) score of 0-1;

Expected survival duration of no less than 8 weeks;

Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);

Disqualifiers

Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;

Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);

Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;

Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;

Trial design

Design model

Parallel

Treatments tested in this trial

Adebrelimab
Drug
Adebrelimab combined with chemotherapy synchronous LDRT
Chemotherapy
Drug
Chemotherapy
low dose radiotherapy
Radiation
low dose radiotherapy

Treatment groups

202 Participants

are divided into 2 treatment groups

Group A: Group AExperimental treatment 3 interventions

Group B: Group BActive comparator 2 interventions

Trial outcomes

Primary outcomes

overall 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

Secondary outcomes

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.

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

Other outcomes

Correlation of PD-L1 expression with overall survival

Pearson correlation coefficient between baseline PD-L1 expression and overall survival (months). Unit of measure: r (dimensionless) with 95% confidence interval. Measurement tool: PD-L1 IHC 22C3 pharmDx assay; PD-L1 tumor proportion score (TPS, %). Assessment schedule: baseline diagnostic biopsy and, if clinically feasible, at the time of first and second tumor progression.

Time frame

From baseline to death from any cause, assessed up to 36 months

Correlation of PD-L1 expression with progression-free survival

Pearson correlation coefficient between baseline PD-L1 TPS and PFS (months). Unit of measure: r (dimensionless) with 95% CI. Measurement tool: PD-L1 IHC 22C3 pharmDx assay; TPS (%). Assessment schedule: baseline tumor biopsy.

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.

Correlation of neutrophil count with overall survival

Pearson correlation coefficient between baseline peripheral blood neutrophil count and overall survival (months). Unit of measure: r (dimensionless) with 95% CI. Measurement tool: automated hematology analyzer; absolute neutrophil count (10⁹/L).

Time frame

From baseline to death from any cause, assessed up to 36 months

Patient-Reported Global Health Status and Quality of Life Score

Change in patient-reported global health status/quality of life score, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life scale (items 29 and 30). Unit of measure: Mean change from baseline in score. Scale Details: The EORTC QLQ-C30 global health status/QoL scale is a 7-point Likert scale ranging from 1 ("Very poor") to 7 ("Excellent"). The raw score is linearly transformed to a 0-100 scale. Higher scores indicate a better quality of life.

Time frame

From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy, assessed up to 36 months

Sponsors and contacts

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Sichuan University

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Collaborator

Source ClinicalTrials.gov

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