Limited-stage Small-cell Lung CancerPhase 2NCT07200154
Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC
A Phase 2 study testing Adebrelimab with concurrent chemoradiotherapy in people with Limited-stage Small-cell Lung Cancer and Concurrent Chemoradiation Therapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited-stage Small-cell Lung Cancer, Concurrent Chemoradiation Therapy
- What is being tested?
- Adebrelimab with concurrent chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 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
- Age 18-75 years, either sex. Histologically or cytologically confirmed limited-stage small-cell lung cancer (LS-SCLC) defined by Veterans Administration Lung Group (VALG) two-stage system.
- Availability of either an archival tumour-tissue block/slides or a newly obtained biopsy from a lesion that has not previously been irradiated.
- ≤ 2 prior cycles of chemotherapy or chemotherapy-naïve. ECOG performance-status 0 or 1. At least one measurable lesion per RECIST 1.1: ≥ 10 mm in longest diameter for non-nodal lesions or ≥ 15 mm in short axis for lymph-node lesions on CT scan.
- Estimated life expectancy ≥ 3 months. Adequate pulmonary function (as judged by the investigator).
- Adequate major organ function defined as:
- Haematology: Hb ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L. Biochemistry: serum albumin ≥ 30 g/L; ALT and AST < 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN.
- Women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrolment and must use effective contraception from screening until ≥ 8 weeks after the last study-dose; men must be surgically sterile or agree to use effective contraception during the same period.
- Voluntary informed consent signed; willing and able to comply with study procedures and follow-up.
Who cannot join
- Prior solid-organ, allogeneic stem-cell or planned transplantation. Immunosuppressive therapy ≤ 14 days before first adebrelimab dose (except intranasal/inhaled corticosteroids or physiological systemic doses equivalent to ≤ 10 mg/day prednisolone).
- Known hypersensitivity to etoposide, cisplatin, adebrelimab, their excipients, or severe allergic reaction to any other monoclonal antibody.
- Live-attenuated vaccine within 4 weeks before first dose or intent to receive one during the study.
- Active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper-/hypothyroidism).
- Uncontrolled asthma requiring bronchodilators or other systemic therapy (childhood asthma fully resolved and requiring no intervention in adulthood is allowed).
- Urinalysis ≥ ++ protein or 24-h urine protein ≥ 1.0 g. Prior malignancy except adequately treated basal-cell or squamous-cell skin carcinoma or cervical carcinoma in situ.
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- HIV infection or known AIDS. Within 6 months before enrolment: myocardial infarction, severe/unstable angina, NYHA class ≥ II heart failure, poorly controlled arrhythmia (including QTcF > 450 ms [men] or > 470 ms [women] by Fridericia), symptomatic congestive heart failure.
- Systemic anti-infective therapy (IV antibiotics, antifungals, or antivirals) within 4 weeks before first dose, or unexplained fever > 38.5 °C during screening or before first dose.
- Active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (anti-HCV positive and HCV-RNA detectable), or HBV/HCV co-infection.
- Participation in another interventional clinical trial within 4 weeks before first dose.
- Known history of substance abuse or recreational drug use. Any severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, could increase study-related risk or interfere with results.
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
Leilei Jiang, MD, 13810737828, drjiangleilei@163.com
About this study
Official title: A Single-arm、Exploratory Study of Adebrelimab in Combination With Chemoradiotherapy Followed by Adebrelimab Maintenance in Patients With Limited-stage Small-cell Lung Cancer
This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.
Read the detailed description
This investigator-initiated trial will be conducted in the Department of Radiation Oncology, Peking University Cancer Hospital. Thirty patients with limited-stage small-cell lung cancer (LS-SCLC) will be enrolled in this pilot study to explore whether the addition of adebrelimab to chemoradiotherapy can improve outcomes for this population.
Eligible participants will receive adebrelimab combined with chemoradiotherapy（etoposide plus platinum). Patients who achieve complete or partial response will undergo prophylactic cranial irradiation (PCI) within 1-30 days after completion of chemoradiotherapy, followed by adebrelimab monotherapy (1200 mg intravenously every 3 weeks) as consolidation and maintenance for up to 24 months in the absence of progression or unacceptable toxicity.
Treatment will be discontinued if the patient develops progressive disease, experiences unacceptable drug-related toxicity, withdraws consent, or meets any other pre-specified withdrawal criterion. Both efficacy (objective response rate, progression-free survival, overall survival) and safety (adverse events graded by CTCAE v5.0) endpoints will be assessed throughout the study.
- Being tested
- Adebrelimab with concurrent chemoradiotherapy
- Keywords
- limited-stage small-cell lung cancer, Immune checkpoint inhibitors, Concurrent Chemoradiation Therapy
- 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 with concurrent chemoradiotherapyDrug
Adebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients meeting inclusion criteria will receive adebrelimab combined with chemotherapy followed by concurrent radiotherapy. Adebrelimab maintenance therapy will be administered until disease progression or intolerable toxicity, for a maximum duration of 2 years. Receives: Drug: Adebrelimab with concurrent chemoradiotherapy |
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200154
- Sponsor's protocol ID
- 2025YJZ78
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm、Exploratory Study of Adebrelimab in Combination With Chemoradiotherapy Followed by Adebrelimab Maintenance in Patients With Limited-stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07200154
- Acronym / sponsor ID
- 2025YJZ78
- Keywords
- limited-stage small-cell lung cancer, Immune checkpoint inhibitors, Concurrent Chemoradiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2025 (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 single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.
Detailed description
This investigator-initiated trial will be conducted in the Department of Radiation Oncology, Peking University Cancer Hospital. Thirty patients with limited-stage small-cell lung cancer (LS-SCLC) will be enrolled in this pilot study to explore whether the addition of adebrelimab to chemoradiotherapy can improve outcomes for this population.
Eligible participants will receive adebrelimab combined with chemoradiotherapy（etoposide plus platinum). Patients who achieve complete or partial response will undergo prophylactic cranial irradiation (PCI) within 1-30 days after completion of chemoradiotherapy, followed by adebrelimab monotherapy (1200 mg intravenously every 3 weeks) as consolidation and maintenance for up to 24 months in the absence of progression or unacceptable toxicity.
Treatment will be discontinued if the patient develops progressive disease, experiences unacceptable drug-related toxicity, withdraws consent, or meets any other pre-specified withdrawal criterion. Both efficacy (objective response rate, progression-free survival, overall survival) and safety (adverse events graded by CTCAE v5.0) endpoints will be assessed throughout the study.
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 | Drug: Adebrelimab with concurrent chemoradiotherapyPatients meeting inclusion criteria will receive adebrelimab combined with chemotherapy followed by concurrent radiotherapy. Adebrelimab maintenance therapy will be administered until disease progression or intolerable toxicity, for a maximum duration of 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years, either sex. Histologically or cytologically confirmed limited-stage small-cell lung cancer (LS-SCLC) defined by Veterans Administration Lung Group (VALG) two-stage system.
- Availability of either an archival tumour-tissue block/slides or a newly obtained biopsy from a lesion that has not previously been irradiated.
- ≤ 2 prior cycles of chemotherapy or chemotherapy-naïve. ECOG performance-status 0 or 1. At least one measurable lesion per RECIST 1.1: ≥ 10 mm in longest diameter for non-nodal lesions or ≥ 15 mm in short axis for lymph-node lesions on CT scan.
- Estimated life expectancy ≥ 3 months. Adequate pulmonary function (as judged by the investigator).
- Haematology: Hb ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L. Biochemistry: serum albumin ≥ 30 g/L; ALT and AST < 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN.
Key exclusion criteria (11 listed)
- Prior solid-organ, allogeneic stem-cell or planned transplantation. Immunosuppressive therapy ≤ 14 days before first adebrelimab dose (except intranasal/inhaled corticosteroids or physiological systemic doses equivalent to ≤ 10 mg/day prednisolone).
- Known hypersensitivity to etoposide, cisplatin, adebrelimab, their excipients, or severe allergic reaction to any other monoclonal antibody.
- Live-attenuated vaccine within 4 weeks before first dose or intent to receive one during the study.
- Active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper-/hypothyroidism).
- Uncontrolled asthma requiring bronchodilators or other systemic therapy (childhood asthma fully resolved and requiring no intervention in adulthood is allowed).
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 with concurrent chemoradiotherapyAdebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years. | Drug | experimental 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
DCR
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
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 30 Sep 2025.
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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 with concurrent chemoradiotherapy in people with Limited-stage Small-cell Lung Cancer and Concurrent Chemoradiation Therapy, 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 8 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 30 Sep 2025. 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 Huiming Yu, MD (010-8819 6984, huiming740512@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 30 Sep 2025.