Small Cell Lung Cancer Extensive StagePhase 2SKYNCT06610734
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)
A Phase 2 study testing Adebrelimab, Chemotherapy and low dose radiotherapy in people with Small Cell Lung Cancer Extensive Stage, run by Sichuan University at 1 site in China.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- Adebrelimab, Chemotherapy and low dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.\"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhuoran Yao, M.D. contact
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Sichuan
You Lu
About this study
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)
Read the 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)
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Adebrelimab, Chemotherapy, low dose radiotherapy
- Keywords
- SCLC, Adebrelimab, LDRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called immunotherapy, Programmed death ligand 1 inhibitor
Adebrelimab combined with chemotherapy synchronous LDRT
ChemotherapyDrug
Chemotherapy
low dose radiotherapyRadiation
low dose radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Adebrelimab combined with chemotherapy synchronous LDRT Receives: Drug: Adebrelimab; Drug: Chemotherapy; Radiation: low dose radiotherapy |
| Group B | Active comparator | Adebrelimab combined with chemotherapy Receives: Drug: Adebrelimab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of randomization to the time when the subject died from any cause, up to approximately 36 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start23 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, You Lu, Sichuan University
- Investigators
- You Lu, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610734
- Sponsor's protocol ID
- SKY
- Other IDs
- 2024 Review (No. 1573)
- Acronym
- SKY
- Status last verified
- Feb 2026
- First submitted
- 14 Sep 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The survival data of individual participant will be shared after the research is completed.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06610734
- Acronym / sponsor ID
- SKY / SKY
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- SCLC, Adebrelimab, LDRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Adebrelimab, Drug: Chemotherapy, Radiation: low dose radiotherapyAdebrelimab combined with chemotherapy synchronous LDRT |
| Group B | Active comparator | Drug: Adebrelimab, Drug: ChemotherapyAdebrelimab combined with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdebrelimabAlso: immunotherapy, Programmed death ligand 1 inhibitorAdebrelimab combined with chemotherapy synchronous LDRT | Drug | Group A, Group B |
| ChemotherapyChemotherapy | Drug | Group A, Group B |
| low dose radiotherapylow dose radiotherapy | Radiation | Group A |
Primary outcome
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).
9 secondary outcomes
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 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
Disease control rate
Time frame: 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
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
Depth of Response
Time frame: 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.
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. The survival data of individual participant will be shared after the research is completed.
Related trials for Small Cell Lung Cancer Extensive Stage
RecruitingPhase 3
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
RecruitingPhase 1/2
Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer
Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
RecruitingPhase 3
A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)
Extensive-stage Small-cell Lung Cancer
RecruitingPhase 3
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhuoran Yao, M.D. contact
You Lu principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Chemotherapy and low dose radiotherapy in people with Small Cell Lung Cancer Extensive Stage, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact You Lu (02885424619, radyoulu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of randomization to the time when the subject died from any cause, up to approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.