Small Cell Lung Cancer (SCLC)Phase 2NCT07909863
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Adebrelimab + Chemotherapy + Radiotherapy in people with Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
- What is being tested?
- Adebrelimab + Chemotherapy + Radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2026to 1 Sep 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
- 1.Patients with pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging.
- 2. No prior systemic therapy for extensive-stage small cell lung cancer.
- 3. Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if clear progression occurs after radiotherapy and this previously irradiated lesion is not the only lesion.
- 4. Aged 18-75 years.
- 5. ECOG performance status: 0-2.
- 6. Expected survival ≥3 months.
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- 7. Adequate hematological and organ function, i.e., meeting the following criteria:
- Hematology (no blood transfusion or blood products and no use of G-CSF or other hematopoietic growth factors for correction within 14 days): i. Absolute neutrophil count (ANC) ≥1.5×10^9/L (1,500/mm^3); ii. Platelet count (PLT) ≥100×10^9/L (100,000/mm^3); iii. Hemoglobin (HB) ≥80 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min; ii. Urine protein <2+ or 24-hour urine protein <1.0 g. c) Hepatic: i. Serum total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Serum albumin (ALB) ≥28 g/L. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.
- 8. Female patients must meet one of the following conditions:
- Menopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause); or
- Surgical sterilization (oophorectomy and/or hysterectomy); or
- Fertile but must meet:
- Serum pregnancy test within 3 days before drug administration must be negative; ii. Agree to use contraceptive measures with an annual failure rate <1% (from signing the ICF until at least 6 months after the last dose of the study drug); iii. Must not breastfeed.
- 9. Male patients must take contraceptive measures as follows: when the partner is a woman of childbearing potential or the partner is pregnant, the male patient must remain abstinent or use a condom during the study treatment period and for at least 6 months after the last dose of the study drug to prevent embryonic exposure to the drug.
- 10. Participants voluntarily agree to participate in this study, sign the informed consent form (ICF), have good compliance, and are willing to cooperate with follow-up.
Who cannot join
- 1. Patients with symptomatic brain metastases. Patients may be enrolled if symptoms remain clinically stable for at least 1 month after treatment of brain metastasis lesions and no steroids or anticonvulsants have been used for at least 1 month before study entry.
- 2. Patients who have previously received thoracic radiotherapy for limited-stage SCLC.
- 3. Prior use of anti-angiogenic drugs such as anlotinib, apatinib, and bevacizumab, or related immunotherapy drugs targeting PD-1, PD-L1, etc.
- 4. Factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.).
- 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 6. Imaging shows that the tumor has invaded the periphery of major blood vessels, or the investigator judges that during the subsequent study period the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding.
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- 7. History of severe bleeding tendency or coagulation dysfunction, including but not limited to: clinically significant hemoptysis within 3 months before enrollment (>1 tablespoon per day); or clinically significant bleeding symptoms or bleeding tendency within 4 weeks before grouping, such as gastrointestinal bleeding, bleeding gastric ulcer (including gastrointestinal perforation and/or fistula; however, patients with gastrointestinal perforation or fistula that has been surgically resected may be allowed to enroll), unhealed wounds, ulcers, or fractures, etc.
- 8. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before grouping.
- 9. Arterial/venous thrombotic events within 6 months before grouping, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
- 10.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose.
- 11.Other conditions that increase the risk of participating in the study or are related to the study drug and, according to the investigator's judgment, may make the patient unsuitable for inclusion in the study.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Single-arm, Single-center, Phase II Clinical Study of Low-dose Radiotherapy Combined With Adebrelimab and Chemotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer
This is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. The primary objective is to assess the efficacy of this approach in prolonging overall survival (OS) and to evaluate its safety in approximately 25 patients.
Read the detailed description
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a two-phase treatment strategy: patients first receive induction therapy with Adebrelimab combined with standard chemotherapy (EC or EP regimen) and concurrent low-dose radiotherapy (5 Gy × 5 fractions); patients achieving disease control then proceed to the maintenance phase with Adebrelimab for up to 2 years. The primary objective is to assess the regimen's efficacy in prolonging overall survival (OS). Secondary objectives include evaluating progression-free survival (PFS), objective response rate (ORR), and safety. The study plans to enroll approximately 25 patients.
- Being tested
- Adebrelimab + Chemotherapy + Radiotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + Chemotherapy + RadiotherapyCombination product
Participants receive a two-phase treatment regimen. Induction (4 fixed cycles, q3w): Adebrelimab (1200 mg IV over 60 minutes, Day 1) followed by investigator's choice of standard platinum-etoposide chemotherapy (EC regimen: Carboplatin AUC=5 on Day 1 + Etoposide 100 mg/m² on Days 1-3; or EP regimen: Cisplatin 75 mg/m² on Day 1 + Etoposide 100 mg/m² on Days 1-3). Concurrent hypofractionated radiotherapy to the primary lung lesion (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Maintenance: Patients without disease progression after 4 cycles continue Adebrelimab (1200 mg IV, q3w) for up to 2 years, until disease progression (per RECIST v1.1), unacceptable grade ≥3 immune-related toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients receive Adebrelimab (1200 mg IV Q3W) combined with standard chemotherapy (EC or EP regimen) for 4 induction cycles. Concurrent low-dose radiotherapy (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Following induction, patients without disease progression (non-PD) continue to receive Adebrelimab (1200 mg IV Q3W) as maintenance therapy for up to 2 years, or until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Combination Product: Adebrelimab + Chemotherapy + Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: From enrollment until death from any cause, assessed up to approximately 24 months.
Secondary outcomes (3)
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From enrollment until disease progression or death, assessed up to approximately 24 months.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Independent Review Committee (IRC) according to RECIST v1.1. Patients must have measurable disease at baseline.
Measured: Assessed at baseline, after induction, and every 3 months during maintenance, up to approximately 24 months.
Safety and Tolerability
Incidence, severity, and frequency of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Measured: From enrollment until 90 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 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 (SCLC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ningbo Liu, Doctor, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909863
- Sponsor's protocol ID
- E20261258
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Phase II Clinical Study of Low-dose Radiotherapy Combined With Adebrelimab and Chemotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07909863
- Acronym / sponsor ID
- E20261258
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Nov 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 is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. The primary objective is to assess the efficacy of this approach in prolonging overall survival (OS) and to evaluate its safety in approximately 25 patients.
Detailed description
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a two-phase treatment strategy: patients first receive induction therapy with Adebrelimab combined with standard chemotherapy (EC or EP regimen) and concurrent low-dose radiotherapy (5 Gy × 5 fractions); patients achieving disease control then proceed to the maintenance phase with Adebrelimab for up to 2 years. The primary objective is to assess the regimen's efficacy in prolonging overall survival (OS). Secondary objectives include evaluating progression-free survival (PFS), objective response rate (ORR), and safety. The study plans to enroll approximately 25 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Combination Product: Adebrelimab + Chemotherapy + RadiotherapyPatients receive Adebrelimab (1200 mg IV Q3W) combined with standard chemotherapy (EC or EP regimen) for 4 induction cycles. Concurrent low-dose radiotherapy (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Following induction, patients without disease progression (non-PD) continue to receive Adebrelimab (1200 mg IV Q3W) as maintenance therapy for up to 2 years, or until disease progression, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1.Patients with pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to VALG staging.
- 2. No prior systemic therapy for extensive-stage small cell lung cancer.
- 3. Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if clear progression occurs after radiotherapy and this previously irradiated lesion is not the only lesion.
- 4. Aged 18-75 years.
- 5. ECOG performance status: 0-2.
Key exclusion criteria (11 listed)
- 1. Patients with symptomatic brain metastases. Patients may be enrolled if symptoms remain clinically stable for at least 1 month after treatment of brain metastasis lesions and no steroids or anticonvulsants have been used for at least 1 month before study entry.
- 2. Patients who have previously received thoracic radiotherapy for limited-stage SCLC.
- 3. Prior use of anti-angiogenic drugs such as anlotinib, apatinib, and bevacizumab, or related immunotherapy drugs targeting PD-1, PD-L1, etc.
- 4. Factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.).
- 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated 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 |
|---|---|---|
| Adebrelimab + Chemotherapy + RadiotherapyParticipants receive a two-phase treatment regimen. Induction (4 fixed cycles, q3w): Adebrelimab (1200 mg IV over 60 minutes, Day 1) followed by investigator's choice of standard platinum-etoposide chemotherapy (EC regimen: Carboplatin AUC=5 on Day 1 + Etoposide 100 mg/m² on Days 1-3; or EP regimen: Cisplatin 75 mg/m² on Day 1 + Etoposide 100 mg/m² on Days 1-3). Concurrent hypofractionated radiotherapy to the primary lung lesion (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Maintenance: Patients without disease progression after 4 cycles continue Adebrelimab (1200 mg IV, q3w) for up to 2 years, until disease progression (per RECIST v1.1), unacceptable grade ≥3 immune-related toxicity, or withdrawal of consent. | Combination product | Experimental Group |
Primary outcome
Overall Survival (OS)
Time frame: From enrollment until death from any cause, assessed up to approximately 24 months.
OS is defined as the time from enrollment to death from any cause.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or death, assessed up to approximately 24 months.
Objective Response Rate (ORR)
Time frame: Assessed at baseline, after induction, and every 3 months during maintenance, up to approximately 24 months.
Safety and Tolerability
Time frame: From enrollment until 90 days after the last dose of study treatment.
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 4 Nov 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.
Ningbo Liu, Doctor principal investigator
Tianjin Medical University Cancer Institute and 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 + Radiotherapy in people with Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and 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 16 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: opening soon, as of the sponsor's last update on 4 Nov 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 Ningbo Liu (+8615602036608, liuningbo@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From enrollment until death from any cause, assessed up to approximately 24 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 4 Nov 2026.