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) (SKY)

February 4, 2026 updated by: You Lu, Sichuan University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

202

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • You Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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);
  • Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.

Exclusion Criteria:

  • 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;
  • History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;
  • Any previous T-cell co-stimulation or immune checkpoint therapies administered;
  • Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Adebrelimab combined with chemotherapy synchronous LDRT
Drug: Chemotherapy
Chemotherapy
Drug: Adebrelimab
Adebrelimab combined with chemotherapy synchronous LDRT
Other Names:
  • immunotherapy
  • Programmed death ligand 1 inhibitor
Radiation: low dose radiotherapy
low dose radiotherapy
Active Comparator: Group B
Adebrelimab combined with chemotherapy
Drug: Chemotherapy
Chemotherapy
Drug: Adebrelimab
Adebrelimab combined with chemotherapy synchronous LDRT
Other Names:
  • immunotherapy
  • Programmed death ligand 1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of randomization to the time when the subject died from any cause, up to approximately 36 months

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).
From date of randomization to the time when the subject died from any cause, up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
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 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.
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)
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

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.
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
Time Frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first.

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.
From date of randomization until disease progression, death, or 24 months, whichever occurs first.
Overall response rate (ORR)
Time Frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first

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.
From date of randomization until disease progression, death, or 24 months, whichever occurs first
Duration of response (DoR)
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

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.
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
Time Frame: From date of randomization until disease progression, death, or 24 months, whichever occurs first.

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.
From date of randomization until disease progression, death, or 24 months, whichever occurs first.
Post-progression survival (PPS)
Time Frame: From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression.

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.
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)
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).

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).
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)
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).

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.
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).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of PD-L1 expression with overall survival
Time Frame: From baseline to death from any cause, assessed up to 36 months

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.
From baseline to death from any cause, assessed up to 36 months
Correlation of PD-L1 expression with progression-free survival
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.
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.
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
Time Frame: From baseline to death from any cause, assessed up to 36 months

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).
From baseline to death from any cause, assessed up to 36 months
Patient-Reported Global Health Status and Quality of Life Score
Time Frame: From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy, assessed up to 36 months

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.
From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy, assessed up to 36 months
Patient-Reported Functioning Scale Scores (Composite of Five Scales)
Time Frame: From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months.

Change in patient-reported functioning, as measured by the five functioning scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning.

Unit of Measure: Mean change from baseline in score for each scale. Scale Details: Each EORTC QLQ-C30 functioning scale consists of multiple items using a 4-point Likert scale (1="Not at all", 4="Very much"). Raw scores are linearly transformed to a 0-100 scale. For functioning scales, higher scores indicate a better level of functioning.
From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months.
Patient-Reported Lung Cancer Symptom Scale Scores (Composite of Scales)
Time Frame: From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months.

Change in patient-reported lung cancer symptoms, as measured by the symptom scales and items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): dyspnoea, cough, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, and pain.

Unit of Measure: Mean change from baseline in score for each symptom scale/item.

Scale Details: EORTC QLQ-LC13 scales use a 4-point Likert scale (1="Not at all", 4="Very much"), transformed to a 0-100 scale. For symptom scales, higher scores indicate a greater severity of symptoms/worse outcome.
From baseline (pre-treatment) to disease progression or death or initiation of new anti-tumour therapy; assessed up to 36 months.
OS in liver-metastasis subgroup
Time Frame: From date of randomization to death from any cause, assessed up to 36 months

Treatment effect (adebrelimab + chemotherapy ± LDRT vs control) on overall survival in the pre-specified subgroup defined by baseline liver metastasis (yes vs no).

Unit of measure: hazard ratio (HR) with 95% confidence interval; median overall survival (months); 12-month survival rate (%).

Measurement tool: death from any cause determined by medical records or death registry.
From date of randomization to death from any cause, assessed up to 36 months
OS in brain-metastasis subgroup
Time Frame: From date of randomization to death from any cause, assessed up to 36 months.

Treatment effect on overall survival in the subgroup defined by baseline brain metastasis (yes vs no).

Unit of measure: HR with 95% CI; median OS (months); 12-month survival rate (%).

Measurement tool: death from any cause determined by medical records or death registry.
From date of randomization to death from any cause, assessed up to 36 months.
PFS in liver-metastasis subgroup
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.

Treatment effect on PFS (RECIST 1.1, investigator) in the liver-metastasis subgroup (yes vs no).

Unit of measure: HR with 95% CI; median PFS (months); 6-month PFS rate (%). Measurement tool: CT/MRI.
From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.
PFS in brain-metastasis subgroup
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.
Treatment effect on PFS in the brain-metastasis subgroup (yes vs no). Unit of measure: HR with 95% CI; median PFS (months); 6-month PFS rate (%). Measurement tool: CT/MRI.
From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Collaborators

Shanghai Shengdi Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: You Lu, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY
  • 2024 Review (No. 1573) (Other Identifier: Biomedical Ethics Review Committee of West China Hospital of Sichuan University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The survival data of individual participant will be shared after the research is completed.

IPD Sharing Time Frame

After the study is completed.

IPD Sharing Access Criteria

Other Medical Professionals with permission from Principle Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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