Localized Small Cell Lung CancerPhase 2NCT07381543
Adebrelimab Maintenance Therapy for LS-SCLC Post Induction Chemo-Adebrelimab Plus CRT or CRT Alone
A Phase 2 study testing Adebrelimab Induction Therapy Group and Adebrelimab Maintenance Therapy Group in people with Localized Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for 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
- Localized Small Cell Lung Cancer
- What is being tested?
- Adebrelimab Induction Therapy Group and Adebrelimab Maintenance Therapy Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Aug 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: 18-75 years old, male or female;
- Patients with pathologically confirmed localized small cell lung cancer (as defined by the Veterans Administration Lung Study Group, VALG staging);
- No anticipated need for tumor resection during the study period (including patients unsuitable for surgery or unwilling to undergo surgery);
- No prior treatment for localized small cell lung cancer;
- Presence of measurable tumor target lesions (meeting RECIST 1.1 criteria);
- Expected survival > 3 months;
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- ECOG PS: 0-1;
- Normal major organ function;
- Complete blood count (CBC) (without transfusion or hematopoietic growth factor correction within 14 days):
- Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 100 × 10⁹/L; White blood cell count (WBC) ≥ 3.0 × 10⁹/L;
- Biochemical tests:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for subjects with Gilbert syndrome); Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min;
- Coagulation function:
- Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin time (PT) ≤ 1.5×ULN;
- Doppler ultrasound assessment:
- Left ventricular ejection fraction (LVEF) ≥50%;
- Women of childbearing potential must have a negative pregnancy test (βHCG) prior to treatment initiation. Women of childbearing potential and males (who have sexual intercourse with women of childbearing potential) must agree to use effective contraception continuously during treatment and for 6 months after the last dose.
- Patients voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Mixed SCLC and extensive-stage SCLC;
- History of other malignancies within the past 5 years or concurrent malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial or non-invasive bladder cancer;
- History of uncontrollable psychiatric disorders or severe intellectual or cognitive impairment;
- Active, known, or suspected autoimmune disease; however, subjects with hypothyroidism requiring only hormone replacement therapy or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are eligible;
- Subjects with any severe and/or uncontrolled medical conditions, including:
- Subjects with uncontrolled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
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- Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including male QTc ≥ 450 ms or female QTc ≥ 470 ms), and ≥ Grade 2 congestive heart failure (New York Heart Association [NYHA] classification);
- Severe unhealed wounds, ulcers, or fractures;
- History of psychiatric drug abuse, alcoholism, or illicit drug use;
- Active hepatitis (HBV reference: HBsAg positive with HBV DNA levels exceeding upper normal limit; HCV reference: HCV antibody positive with HCV viral load exceeding upper normal limit);
- Human Immunodeficiency Virus (HIV, HIV 1/2 antibody) positive;
- Patients unable to comply with the study protocol or participate in follow-up visits;
- Patients deemed unsuitable for this trial by the investigator.
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
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100142
Rong Yu, Physician, 13501147200, yurong311@aliyun.com
About this study
Official title: A Prospective, Exploratory, Two-Arm Study of Adebrelimab Maintenance Therapy in Limited-Stage Small Cell Lung Cancer Following Either Induction Chemo-Adebrelimab Plus Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Alone
Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer
Read the detailed description
The study comprises two cohorts (A and B). Cohort A first receives two cycles of induction therapy combining PD-L1 inhibitors with chemotherapy, followed by two cycles of concurrent chemoradiotherapy and subsequent maintenance therapy with PD-L1 inhibitors. Cohort B first undergoes four cycles of concurrent chemoradiotherapy followed by maintenance therapy with PD-L1 inhibitors. Both cohorts continue treatment until disease progression or intolerable toxicity occurs.
- Conditions
- Localized Small Cell Lung Cancer
- Being tested
- Adebrelimab Induction Therapy Group, Adebrelimab Maintenance Therapy Group
- Keywords
- Localized small cell lung cancer, Without prior systemic anticancer therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab Induction Therapy GroupDrug
Induction Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Radiotherapy: 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD.
Maintenance Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks
Adebrelimab Maintenance Therapy GroupDrug
Concurrent chemoradiotherapy radiotherapy : 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Maintenance therapy Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Induction Therapy Group | Experimental | Induction Phase adebrelimab combined with etoposide and platinum-based chemotherapy Concurrent Chemoradiotherapy Phase Radiotherapy initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, combined with etoposide and platinum-based chemotherapy Maintenance Phase adebrelimab administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment. Receives: Drug: Adebrelimab Induction Therapy Group |
| Adebrelimab Maintenance Therapy Group | Experimental | Radiotherapy is initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, in combination with etoposide and platinum-based agents.
Maintenance Phase adebrelimab is administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment. Receives: Drug: Adebrelimab Maintenance Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first
Measured: through study completion, an average of 3 years
Secondary outcomes (4)
ORR
The proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response following treatment initiation, relative to the total number of subjects.
Measured: through study completion, an average of 3 years
OS
Time from subject enrollment to death from any cause.
Measured: through study completion, an average of 3 years
Adverse Events
AEs that occurred from the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
Measured: From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
DCR
The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) as their best overall response following treatment initiation, relative to the total number of subjects.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minglei Zhuo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381543
- Sponsor's protocol ID
- 2025YJZ146
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2026
- Last updated
- 4 Feb 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory, Two-Arm Study of Adebrelimab Maintenance Therapy in Limited-Stage Small Cell Lung Cancer Following Either Induction Chemo-Adebrelimab Plus Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Alone
- ClinicalTrials.gov ID
- NCT07381543
- Acronym / sponsor ID
- 2025YJZ146
- Conditions
- Localized Small Cell Lung Cancer
- Keywords
- Localized small cell lung cancer, Without prior systemic anticancer therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Feb 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.
Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer
Detailed description
The study comprises two cohorts (A and B). Cohort A first receives two cycles of induction therapy combining PD-L1 inhibitors with chemotherapy, followed by two cycles of concurrent chemoradiotherapy and subsequent maintenance therapy with PD-L1 inhibitors. Cohort B first undergoes four cycles of concurrent chemoradiotherapy followed by maintenance therapy with PD-L1 inhibitors. Both cohorts continue treatment until disease progression or intolerable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Induction Therapy Group | Experimental | Drug: Adebrelimab Induction Therapy GroupInduction Phase adebrelimab combined with etoposide and platinum-based chemotherapy Concurrent Chemoradiotherapy Phase Radiotherapy initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, combined with etoposide and platinum-based chemotherapy Maintenance Phase adebrelimab administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment. |
| Adebrelimab Maintenance Therapy Group | Experimental | Drug: Adebrelimab Maintenance Therapy GroupRadiotherapy is initiated prior to the third cycle of chemotherapy, no later than the start of the third cycle, in combination with etoposide and platinum-based agents. Maintenance Phase adebrelimab is administered until disease progression, intolerable toxicity, or a maximum of 2 years of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: 18-75 years old, male or female;
- Patients with pathologically confirmed localized small cell lung cancer (as defined by the Veterans Administration Lung Study Group, VALG staging);
- No anticipated need for tumor resection during the study period (including patients unsuitable for surgery or unwilling to undergo surgery);
- No prior treatment for localized small cell lung cancer;
- Presence of measurable tumor target lesions (meeting RECIST 1.1 criteria);
Key exclusion criteria (13 listed)
- Mixed SCLC and extensive-stage SCLC;
- History of other malignancies within the past 5 years or concurrent malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial or non-invasive bladder cancer;
- History of uncontrollable psychiatric disorders or severe intellectual or cognitive impairment;
- Active, known, or suspected autoimmune disease; however, subjects with hypothyroidism requiring only hormone replacement therapy or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are eligible;
- Subjects with any severe and/or uncontrolled medical conditions, including:
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 Induction Therapy GroupInduction Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Radiotherapy: 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD. Maintenance Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks | Drug | Adebrelimab Induction Therapy Group |
| Adebrelimab Maintenance Therapy GroupConcurrent chemoradiotherapy radiotherapy : 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Maintenance therapy Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks | Drug | Adebrelimab Maintenance Therapy Group |
Primary outcome
PFS
Time frame: through study completion, an average of 3 years
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first
4 secondary outcomes
ORR
Time frame: through study completion, an average of 3 years
OS
Time frame: through study completion, an average of 3 years
Adverse Events
Time frame: From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
DCR
Time frame: through study completion, an average of 3 years
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 Feb 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 Adebrelimab Induction Therapy Group and Adebrelimab Maintenance Therapy Group in people with Localized Small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute 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 18 inclusion and 13 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 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 Minglei Zhuo, Physician (010-88196456, trialminglei@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: through study completion, an average of 3 years). 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 Feb 2026.