LungPhase 2NCT07583550
Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing Etoposide, Cisplatin and Carboplatin in people with Lung and Radiotherapy, run by Jiangmen Central Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective investigation aiming to evaluate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy concurrently with Adebrelimab, followed by Adebrelimab maintenance therapy for up to two years, in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung, Radiotherapy
- What is being tested?
- Etoposide, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 1 Jan 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
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed SCLC.
- No prior thoracic radiotherapy or thoracic surgery.
- No prior systemic anti-tumor therapy.
- ECOG performance status 0-2 and life expectancy ≥12 weeks.
- At least one measurable lesion per RECIST 1.1.
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- Adequate bone marrow function to tolerate anti-tumor therapy: WBC ≥3×10⁹/L, Hb ≥80 g/L, PLT ≥75×10⁹/L, and absolute neutrophil count (NEUT) ≥1.5×10⁹/L.
- Essentially normal hepatic and renal function: 8.1. Serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min; 8.2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN is acceptable in patients with liver metastases); 8.3. Total bilirubin (TBIL) ≤1.5×ULN; 8.4. Albumin ≥30 g/L and prealbumin ≥150 g/L.
- Urine protein ≤1+ or <1000 mg/24h.
- All patients have provided full informed consent.
Who cannot join
- Pre-existing interstitial lung disease (with or without clinical symptoms) or uncontrolled infectious pneumonia (e.g., accompanied by cough, fever >38°C, dyspnea, tachypnea, etc.) prior to treatment.
- Concomitant autoimmune disease, or long-term oral corticosteroid use (including oral corticosteroids within 14 days before treatment).
- Allergy to adebrelimab.
- Positive HIV antibody, active hepatitis B (HBV-DNA >10³ IU/mL), active hepatitis C (HCV-RNA above the lower limit of detection of the study site), active pulmonary tuberculosis (defined as: fever, night sweats, chest pain, etc.; or acid-fast bacilli found in sputum or bronchoalveolar lavage fluid; or chest CT showing active signs such as patchy infiltrates or cavities), or positive syphilis antibody.
- Moderate or large pleural effusion (maximum depth >3 cm on chest ultrasound or CT, estimated volume >500 mL) or moderate or large pericardial effusion (maximum diastolic width >1 cm on echocardiography, estimated volume >100 mL), or poorly controlled pleural/pericardial effusion (defined as requiring ≥2 drainage procedures within 1 month). Patients may be enrolled if effusion becomes minimal or undetectable after drainage.
- MRI evidence of leptomeningeal, brainstem, or spinal cord metastases, or symptomatic brain metastases (e.g., headache, nausea, vomiting, visual impairment, or visual field defects).
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- Severe cardiac or cerebrovascular disease, including: New York Heart Association (NYHA) class ≥2 heart failure; acute coronary syndrome (e.g., myocardial infarction, unstable angina) within 6 months before enrollment; frequent and uncontrolled arrhythmias (excluding transient atrial fibrillation/flutter) despite antiarrhythmic therapy for ≥2 weeks; acute cerebrovascular events (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage).
- Hypertension poorly controlled despite two antihypertensive agents (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg).
- Poorly controlled blood glucose (defined as: 1. two consecutive fasting blood glucose values >10 mmol/L; or 2. HbA1c ≥8%), or diabetic gangrene.
- Any deep vein thrombosis (allowed if stable on low-molecular-weight heparin or similar therapy for >2 weeks), arterial thrombosis, or pulmonary embolism.
- Pregnant or lactating women, or women of childbearing potential who are unwilling to use effective contraception during the study and for at least 6 months after the last dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
About this study
Official title: Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study
This study is a multicenter, prospective investigation aiming to evaluate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy concurrently with Adebrelimab, followed by Adebrelimab maintenance therapy for up to two years, in subjects with extensive-stage small cell lung cancer (ES-SCLC). Additionally, immunohistochemical detection of the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-will be performed to guide the molecular subtyping of SCLC. Based on these findings, we will explore the differential therapeutic outcomes of this regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this treatment modality, thereby optimizing clinical decision-making.
Read the detailed description
This study plans to prospectively enroll 43 subjects with extensive-stage small cell lung cancer (ES-SCLC) without malignant pleural effusion from multiple centers. All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy/fraction × 10 fractions, BID). Within one week after radiotherapy completion, subjects will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined with adebrelimab (anti-PD-L1 antibody), followed by adebrelimab maintenance therapy for two years. Through this regimen, we aim to achieve survival outcomes comparable to or even superior to those of the MATCH study from West China Hospital (median PFS 6.9 months, median OS 16.9 months) and the NCT04562337 study from Shandong Cancer Hospital (median PFS 10.1 months, median OS 21.4 months), with manageable toxicity profiles.
Additionally, immunohistochemistry (IHC) will be performed to detect the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-which are used to guide the molecular subtyping of small cell lung cancer. Based on these results, we will investigate the differential efficacy of this treatment regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this approach and ultimately better serving clinical practice.
- Conditions
- Lung, Radiotherapy
- Being tested
- Etoposide, Cisplatin, Carboplatin, Adebrelimab, Thoracic Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Etoposide 100 mg/m² on days 1-3 plus cisplatin 25 mg/m² on days 1-3, every 3 weeks (q3w), or etoposide 100 mg/m² on days 1-3 plus carboplatin AUC 5 on day 1, every 3 weeks (q3w).
CisplatinDrug
Etoposide (100 mg/m²) and cisplatin (25 mg/m²) were administered on days 1-3 of each 3-week cycle.
CarboplatinDrug
Etoposide (100 mg/m²) was given on days 1-3 and carboplatin (AUC 5) on day 1 of each 3-week cycle.
AdebrelimabDrug
20 mg/kg intravenously on day 1, repeated every 21 days (q3w). Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years.
Thoracic RadiotherapyRadiation
All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID). Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab. Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Radiotherapy + EP/EC + Adebrelimab | Experimental | All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID). Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab. Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years. Receives: Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin; Drug: Adebrelimab; Radiation: Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival（PFS）
Progression-free survival (PFS), defined as the time from the initiation of radiotherapy to the first documented disease recurrence/progression, metastasis, or death from any cause.
Measured: From the date of first radiotherapy to the date of first documented disease progression, metastasis.
Secondary outcomes (5)
Overall Survival (OS)
Overall survival (OS), defined as the time from the initiation of radiotherapy to death from any cause.
Measured: From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
Overall Response Rate (ORR)
The objective response rate (ORR), defined as the proportion of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria based on evaluable lesions in the lungs and distant metastases (including primary tumor, lymph nodes, and distant metastatic lesions), relative to the total enrolled population.
Measured: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
Disease Control Rate (DCR)
The disease control rate (DCR), defined as the proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria based on evaluable lesions in the lungs and distant metastases (including primary tumor, lymph nodes, and distant metastatic lesions), relative to the total enrolled population.
Measured: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
Incidence of Treatment-Emergent Adverse Events
Frequency, severity, and relationship of adverse events assessed by CTCAE v5.0.
Measured: From date of first low-dose radiotherapy to 30 days after last dose.
To investigate the association between distinct molecular subtypes and clinical outcomes, including prognosis and treatment-related toxicity.
Immunohistochemistry (IHC) for YAP1, NEUROD1, ASCL1, and POU2F3 to determine molecular subtypes; prognosis assessed via Kaplan-Meier and Cox regression; toxicity graded per CTCAE v5.0.
Measured: Baseline: collect tumor tissue (archived FFPE or fresh biopsy) prior to treatment initiation; prognosis follow-up until progression or death (imaging q6w, survival q3m); toxicity monitoring until 30 days post-last dose (recorded at each visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start20 Jul 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangmen Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Xiao, Jiangmen Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583550
- Sponsor's protocol ID
- 2026 049 A
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy and Sequential Adebrelimab Maintenance Therapy for Extensive-stage Small Cell Lung Cancer: A Prospective, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT07583550
- Acronym / sponsor ID
- 2026 049 A
- Conditions
- Lung, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Jiangmen Central HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 May 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 is a multicenter, prospective investigation aiming to evaluate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy concurrently with Adebrelimab, followed by Adebrelimab maintenance therapy for up to two years, in subjects with extensive-stage small cell lung cancer (ES-SCLC). Additionally, immunohistochemical detection of the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-will be performed to guide the molecular subtyping of SCLC. Based on these findings, we will explore the differential therapeutic outcomes of this regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this treatment modality, thereby optimizing clinical decision-making.
Detailed description
This study plans to prospectively enroll 43 subjects with extensive-stage small cell lung cancer (ES-SCLC) without malignant pleural effusion from multiple centers. All subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy/fraction × 10 fractions, BID). Within one week after radiotherapy completion, subjects will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined with adebrelimab (anti-PD-L1 antibody), followed by adebrelimab maintenance therapy for two years. Through this regimen, we aim to achieve survival outcomes comparable to or even superior to those of the MATCH study from West China Hospital (median PFS 6.9 months, median OS 16.9 months) and the NCT04562337 study from Shandong Cancer Hospital (median PFS 10.1 months, median OS 21.4 months), with manageable toxicity profiles.
Additionally, immunohistochemistry (IHC) will be performed to detect the expression levels of four key transcriptional proteins-YAP1, NEUROD1, ASCL1, and POU2F3-which are used to guide the molecular subtyping of small cell lung cancer. Based on these results, we will investigate the differential efficacy of this treatment regimen across distinct molecular subtypes (A/N/P/Y/I/AN/QN), with the goal of identifying the subject population most likely to benefit from this approach and ultimately better serving clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Radiotherapy + EP/EC + Adebrelimab | Experimental | Drug: Etoposide, Drug: Cisplatin, Drug: Carboplatin, Drug: Adebrelimab, Radiation: Thoracic RadiotherapyAll subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID). Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab. Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed SCLC.
- No prior thoracic radiotherapy or thoracic surgery.
- No prior systemic anti-tumor therapy.
- ECOG performance status 0-2 and life expectancy ≥12 weeks.
Key exclusion criteria (11 listed)
- Pre-existing interstitial lung disease (with or without clinical symptoms) or uncontrolled infectious pneumonia (e.g., accompanied by cough, fever >38°C, dyspnea, tachypnea, etc.) prior to treatment.
- Concomitant autoimmune disease, or long-term oral corticosteroid use (including oral corticosteroids within 14 days before treatment).
- Allergy to adebrelimab.
- Positive HIV antibody, active hepatitis B (HBV-DNA >10³ IU/mL), active hepatitis C (HCV-RNA above the lower limit of detection of the study site), active pulmonary tuberculosis (defined as: fever, night sweats, chest pain, etc.; or acid-fast bacilli found in sputum or bronchoalveolar lavage fluid; or chest CT showing active signs such as patchy infiltrates or cavities), or positive syphilis antibody.
- Moderate or large pleural effusion (maximum depth >3 cm on chest ultrasound or CT, estimated volume >500 mL) or moderate or large pericardial effusion (maximum diastolic width >1 cm on echocardiography, estimated volume >100 mL), or poorly controlled pleural/pericardial effusion (defined as requiring ≥2 drainage procedures within 1 month). Patients may be enrolled if effusion becomes minimal or undetectable after drainage.
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 |
|---|---|---|
| EtoposideEtoposide 100 mg/m² on days 1-3 plus cisplatin 25 mg/m² on days 1-3, every 3 weeks (q3w), or etoposide 100 mg/m² on days 1-3 plus carboplatin AUC 5 on day 1, every 3 weeks (q3w). | Drug | Low-Dose Radiotherapy + EP/EC + Adebrelimab |
| CisplatinEtoposide (100 mg/m²) and cisplatin (25 mg/m²) were administered on days 1-3 of each 3-week cycle. | Drug | Low-Dose Radiotherapy + EP/EC + Adebrelimab |
| CarboplatinEtoposide (100 mg/m²) was given on days 1-3 and carboplatin (AUC 5) on day 1 of each 3-week cycle. | Drug | Low-Dose Radiotherapy + EP/EC + Adebrelimab |
| Adebrelimab20 mg/kg intravenously on day 1, repeated every 21 days (q3w). Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years. | Drug | Low-Dose Radiotherapy + EP/EC + Adebrelimab |
| Thoracic RadiotherapyAll subjects will first receive low-dose radiotherapy (DT 15 Gy, 1.5 Gy per fraction × 10 fractions, BID). Within one week after radiotherapy completion, they will receive 4-6 cycles of systemic chemotherapy (EP or EC regimen) combined concurrently with adebrelimab. Following the 4-6 cycles of chemo-immunotherapy, adebrelimab maintenance therapy will be continued for two years. | Radiation | Low-Dose Radiotherapy + EP/EC + Adebrelimab |
Primary outcome
Progression-Free Survival（PFS）
Time frame: From the date of first radiotherapy to the date of first documented disease progression, metastasis.
Progression-free survival (PFS), defined as the time from the initiation of radiotherapy to the first documented disease recurrence/progression, metastasis, or death from any cause.
5 secondary outcomes
Overall Survival (OS)
Time frame: From date of first radiotherapy to date of death from any cause, assessed up to 36 months.
Overall Response Rate (ORR)
Time frame: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
Disease Control Rate (DCR)
Time frame: Baseline (within 28 days prior to first dose), then every 8 weeks (±7 days) from radiotherapy initiation until 2 years post-treatment.
Incidence of Treatment-Emergent Adverse Events
Time frame: From date of first low-dose radiotherapy to 30 days after last dose.
To investigate the association between distinct molecular subtypes and clinical outcomes, including prognosis and treatment-related toxicity.
Time frame: Baseline: collect tumor tissue (archived FFPE or fresh biopsy) prior to treatment initiation; prognosis follow-up until progression or death (imaging q6w, survival q3m); toxicity monitoring until 30 days post-last dose (recorded at each visit).
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 22 Sep 2026.
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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.
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 Etoposide, Cisplatin and Carboplatin in people with Lung and Radiotherapy, run by Jiangmen Central Hospital 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 10 inclusion and 11 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 22 Sep 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 Lin Xiao (0750-3165972, xiaolin7966165@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival（PFS） (time frame: From the date of first radiotherapy to the date of first documented disease progression, metastasis.). 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 22 Sep 2026.