SCLC, Limited StagePhase 2ARL-LS-SCLCNCT07559786
A Multicenter, Open-label, Randomized, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy
A Phase 2 study testing CCRT(Employed residual field irradiation(RFI)) and CCRT(Involved-Field Radiotherapy (IFRT)) in people with SCLC, Limited Stage, run by Henan Cancer Hospital at 2 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Limited Stage
- What is being tested?
- CCRT(Employed residual field irradiation(RFI)) and CCRT(Involved-Field Radiotherapy (IFRT))
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jul 2026to 17 Jul 2029
- 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
- 1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable radiation plan).
- 3.Clinically staged T1-2N0, operable LS-SCLC patients who are ineligible for surgery or refuse surgery.
- 4.ECOG performance status 0-1. 5.Expected survival ≥ 3 months. 6.At least one measurable lesion per RECIST 1.1. 7.Pulmonary function: FEV1 > 70% of predicted value. 8.Adequate hematologic and end-organ function, with laboratory results obtained within 7 days before first study treatment:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹/L; platelet count (PLT) ≥ 90×10⁹/L without transfusion, G-CSF, or other hematopoietic stimulants within 14 days before first treatment.
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for patients with confirmed Gilbert syndrome).
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation); urine protein < 2+ (if urine protein ≥ 2+, 24-hour urine protein must be < 1 g for eligibility).
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- Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Sexually active subjects of reproductive potential (non-sterilized) must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after treatment completion. For females of reproductive potential: serum pregnancy test (HCG) must be negative within 7 days before first dosing.
- 10.Subjects are voluntarily enrolled, provide written informed consent, have good compliance, and agree to follow-up.
Who cannot join
- Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
- Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.
- Extensive-stage SCLC.
- Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells.
- Subjects with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc.
- History of active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
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- (Exceptions: Type 1 diabetes mellitus (glycemic control with insulin); residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; conditions not expected to relapse in the absence of external trigger.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo only (excluding psoriatic arthritis) may be enrolled if: rash involves <10% of body surface area; disease is well controlled at baseline with only low-potency topical steroids; and no acute exacerbation in the past 12 months (no PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids).)
- Concomitant malignancy diagnosed ≤3 years before first study treatment, except adequately treated papillary thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin cancer, locally controlled prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed).
- History of clinically significant cardiovascular disease, including but not limited to:
- Congestive heart failure (NYHA class >2); Unstable angina; Myocardial infarction within 3 months before signing ICF; Any severe supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Severe infection within 4 weeks before first treatment, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection of CTCAE grade ≥2 requiring systemic antibiotics within 2 weeks before first treatment.
- Active tuberculosis within 1 year before enrollment by history or CT scan, or history of active tuberculosis >1 year ago without standard treatment.
- History of immunodeficiency, including positive HIV serology.
- Active hepatitis B or hepatitis C.(HBsAg-positive or HBcAb-positive subjects may be enrolled if HBV DNA < upper limit of normal (ULN) of the local laboratory (if no ULN, HBV DNA <1000 copies/mL or 500 IU/mL); HCV Ab-positive subjects may be enrolled if HCV RNA < ULN of the local laboratory (if no ULN, HCV RNA <500 IU/mL).)
- Receipt of systemic immunosuppressive therapy within 14 days before first treatment, including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents.
- (1)Patients receiving short-term systemic immunosuppression (e.g., corticosteroids for management/prophylaxis of nausea, vomiting, or hypersensitivity) may be enrolled at the investigator's discretion; a washout period before randomization may be required.
- (2)Allowed: inhaled corticosteroids for COPD; mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension; low-dose corticosteroid replacement (≤10 mg/day prednisone or equivalent) for adrenal insufficiency.
- 14.Major surgery within 28 days before first treatment (except diagnostic surgery), or expected major surgery during the study (except diagnostic surgery).
- 15.Administration of live attenuated vaccine within 28 days before first treatment, or anticipated need during the study (live attenuated influenza vaccine is prohibited within 28 days before first treatment, during treatment, and for 5 months after the last dose of adebrelimab).
- 16.Prior allogeneic bone marrow transplant or solid organ transplant. 17.History of severe hypersensitivity to monoclonal antibody/fusion protein drugs.
- 18.Known psychiatric disorder, alcoholism, drug abuse or substance abuse. 19.Any other condition that, in the investigator's judgment, may prematurely terminate the study, e.g., poor protocol compliance, other severe diseases requiring concurrent treatment, significant laboratory abnormalities, or family/social factors affecting subject safety or data/sample collection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
QiMing QM Wang, Professor, +8613783590691, qimingwang1006@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
QiMing QM Wang, Professor, +8613783590691, qimingwang1006@126.com
About this study
This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle. After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.
- Conditions
- SCLC, Limited Stage
- Being tested
- CCRT(Employed residual field irradiation(RFI)), CCRT(Involved-Field Radiotherapy (IFRT))
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRT(Employed residual field irradiation(RFI))Other
Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic radiotherapy(employed residual field irradiation, RFI), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
CCRT(Involved-Field Radiotherapy (IFRT))Other
Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Employed residual field irradiation | Experimental | Carboplatin + Etoposide plus thoracic residual-field radiotherapy (employed residual field irradiation,RFI), followed by maintenance therapy with adebrelimab in patients without progressive disease (non-PD) Receives: Other: CCRT(Employed residual field irradiation(RFI)) |
| Arm B:Nodal involved-field radiotherapy group | Experimental | Carboplatin + Etoposide plus thoracic involved-field radiotherapy (Nodal involved-field radiotherapy group, IFRT), followed by maintenance therapy with adebrelimab in patients without progressive disease Receives: Other: CCRT(Involved-Field Radiotherapy (IFRT)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival: Time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
Measured: From date of the first treatment to the first documented disease progression, assessed up to 18 months
Secondary outcomes (7)
L-PFS
local progression-free survival: Time from start of concurrent CCRT to first local progression post-maintenance or all-cause death, whichever occurs first
Measured: From date of the first treatment to the first documented disease progression, assessed up to 18 months
M-PFS
Metastasis-Progression Free Survival (M-PFS): Defined as the time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective distant tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
Measured: From date of the first treatment to the first documented disease progression, assessed up to 18 months
OS
Overall Survival (OS): The time from the date of initiating study treatment at enrollment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last known alive.
Measured: From date of the first treatment to death due to any cause, assessed up to 18 months
DCR
Disease Control Rate (DCR): The proportion of patients with tumor shrinkage or stabilization maintained for a specified duration, including subjects with Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Measured: From date of the first treatment to18 months
DoR
Duration of Response (DoR): The time from the date of confirmed CR or PR by imaging to the occurrence of disease progression or death without progression
Measured: from the date of first documented CR or PR to disease progression or death, censored at last evaluable assessment; maximum follow-up of 18 months
ORR
Objective Response Rate (ORR): The proportion of subjects with tumor reduction achieving a predefined magnitude and maintained for a specified duration, including those with Complete Response (CR) and Partial Response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Measured: Confirmed objective response observed within 18 months from start of treatment
AE
Incidence of adverse events assessed by CTCAE v5.0
Measured: From signing of informed consent through 30 days after last dose (or 90 days for serious AEs), assessed at the end of every cycle (each cycle = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start17 Jul 2026 (estimated)
- Primary completion17 Jul 2029 (estimated)
- Study completion17 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Limited 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559786
- Sponsor's protocol ID
- ARL-LS-SCLC
- Acronym
- ARL-LS-SCLC
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT07559786
- Acronym / sponsor ID
- ARL-LS-SCLC / ARL-LS-SCLC
- Conditions
- SCLC, Limited Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 17 Jul 2026 (estimated)
- Primary completion
- 17 Jul 2029 (estimated)
- Study completion
- 17 Jul 2029 (estimated)
- First posted
- 30 Apr 2026 (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.
This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle. After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Employed residual field irradiation | Experimental | Other: CCRT(Employed residual field irradiation(RFI))Carboplatin + Etoposide plus thoracic residual-field radiotherapy (employed residual field irradiation,RFI), followed by maintenance therapy with adebrelimab in patients without progressive disease (non-PD) |
| Arm B:Nodal involved-field radiotherapy group | Experimental | Other: CCRT(Involved-Field Radiotherapy (IFRT))Carboplatin + Etoposide plus thoracic involved-field radiotherapy (Nodal involved-field radiotherapy group, IFRT), followed by maintenance therapy with adebrelimab in patients without progressive disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable radiation plan).
- 3.Clinically staged T1-2N0, operable LS-SCLC patients who are ineligible for surgery or refuse surgery.
- 4.ECOG performance status 0-1. 5.Expected survival ≥ 3 months. 6.At least one measurable lesion per RECIST 1.1. 7.Pulmonary function: FEV1 > 70% of predicted value. 8.Adequate hematologic and end-organ function, with laboratory results obtained within 7 days before first study treatment:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹/L; platelet count (PLT) ≥ 90×10⁹/L without transfusion, G-CSF, or other hematopoietic stimulants within 14 days before first treatment.
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg/dL for patients with confirmed Gilbert syndrome).
Key exclusion criteria (22 listed)
- Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).
- Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.
- Extensive-stage SCLC.
- Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells.
- Subjects with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc.
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 |
|---|---|---|
| CCRT(Employed residual field irradiation(RFI))Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic radiotherapy(employed residual field irradiation, RFI), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w. | Other | Arm A: Employed residual field irradiation |
| CCRT(Involved-Field Radiotherapy (IFRT))Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w. | Other | Arm B:Nodal involved-field radiotherapy group |
Primary outcome
PFS
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
progression-free survival: Time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
7 secondary outcomes
L-PFS
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
M-PFS
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
OS
Time frame: From date of the first treatment to death due to any cause, assessed up to 18 months
DCR
Time frame: From date of the first treatment to18 months
DoR
Time frame: from the date of first documented CR or PR to disease progression or death, censored at last evaluable assessment; maximum follow-up of 18 months
ORR
Time frame: Confirmed objective response observed within 18 months from start of treatment
AE
Time frame: From signing of informed consent through 30 days after last dose (or 90 days for serious AEs), assessed at the end of every cycle (each cycle = 21 days)
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCRT(Employed residual field irradiation(RFI)) and CCRT(Involved-Field Radiotherapy (IFRT)) in people with SCLC, Limited Stage, run by Henan Cancer Hospital at 2 sites 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 9 inclusion and 22 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Qingminf QM Wang, Professor (+8613783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 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 21 Jul 2026.