SCLC, Extensive StagePhase 2NCT06768307
Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC in people with SCLC, Extensive Stage and Immunotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Extensive Stage, Immunotherapy, Chemotherapy
- What is being tested?
- First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2025to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, no gender restrictions;
- Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a/b/c) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor/nodule size too large to be included in a tolerable radiation therapy plan;
- Participants have not received systemic treatment for extensive-stage SCLC;
- No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);
- ECOG performance status score of 0-2;
- Life expectancy ≥3 months;
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- Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;
- Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:
- Hemoglobin (Hb) ≥90g/L; Platelet (PLT) ≥100×10^9/L; Neutrophil count (ANC) ≥1.5×10^9/L; White blood cell count (WBC) ≥3.0×10^9/L;
- Lymphocyte ≥0.5×10^9/L; b) Biochemistry:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 2.5×ULN; For those with liver metastasis, ALT, AST≤5 ULN; For those with liver or bone metastasis: ALP ≤5 ULN; Total serum bilirubin (TBIL) ≤1.5×ULN (for Gilbert's syndrome participants ≤3×ULN); Albumin (ALB) ≥3 g/dL;
- Renal function: Serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50mL/minute (using Cockcroft/Gault formula); c) Coagulation:
- Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤1.5×ULN; d) Others: Lipase ≤1.5 x ULN. Participants with lipase >1.5 x ULN without clinical or radiological evidence of pancreatitis can be included; e) Doppler echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
- Female participants of childbearing potential must have a negative serum HCG test within 72 hours before the first dose, not breastfeeding, and must use a medically recognized contraceptive method (such as intrauterine devices, birth control pills, or condoms) during the study treatment and for 2 months after the last dose of Adebrelimab or 6 months after the last dose of Carboplatin/Etoposide (whichever is longer); male participants with partners of childbearing potential must be surgically sterilized or agree to use highly effective contraception during the trial and for 2 months after the last dose of Adebrelimab or 3 months after the last dose of Carboplatin/Etoposide (whichever is longer), and no sperm donation during the study.
Who cannot join
- Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other T-cell targeted drugs.
- Participants who have previously received chemoradiotherapy for limited-stage SCLC;
- Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size <1cm are allowed to be included);
- Participants with multiple liver metastases (isolated liver metastasis participants with metastasis <2cm can be included)
- Participants with spinal cord compression;
- Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose, or with a history of autoimmune diseases and expected recurrence. Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;
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- Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first dose; the use of physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) is allowed;
- Participants who have had arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;
- Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) at screening (participants with active tuberculosis are not included);
- Participants who have undergone major surgical treatment or significant traumatic injury within 28 days before the first dose;
- Participants who have received or plan to receive preventive vaccines or live-attenuated vaccines within 4 weeks before the first dose;
- Participants who have received other trial medications or participated in another interventional clinical study within 4 weeks before signing the ICF;
- Participants with other malignancies that require active treatment within 5 years (except for those with a >90% 5-year survival rate such as fully treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, or in situ breast cancer);
- Participants with any severe and/or uncontrolled diseases, including: a) Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90mmHg) participants; history of hypertensive crisis or hypertensive encephalopathy; b) Uncontrolled cardiac clinical symptoms or diseases such as ≥grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmias (including men QTc ≥450ms, women QTc ≥470ms), and ≥grade 2 congestive heart failure (New York Heart Association, NYHA classification), unstable angina, myocardial infarction within 24 weeks, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; c) Active or uncontrolled severe infections (≥CTC AE grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, unexplained fever >38.5℃ before the first dose. d) Liver cirrhosis, active hepatitis*; *Active hepatitis - Hepatitis B reference: HBsAg positive, exceeding the upper limit of normal (1000 copies/ml or 500 IU/ml); participants with past Hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HbsAg, and normal HBV DNA values detected during the screening period can be included; *Hepatitis C reference: HCV antibody positive, and HCV viral load exceeds the upper limit of normal/HCV RNA or HCV Ab indicates acute or chronic infection; e) HIV positive or known Acquired Immune Deficiency Syndrome (AIDS); f) Urine routine suggests urinary protein ≥++, and confirmed 24-hour urinary protein quantification >1.0 g;
- Participants with clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, and abdominal effusion requiring repeated drainage (such as once a month or more frequently) that cannot be controlled by tapping or other treatments;
- Participants whose adverse events (except for alopecia) caused by previous treatments have not recovered to ≤CTCAE grade 1; other toxicities caused by previous antitumor treatments that are expected to be unresolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based treatments, are allowed to be included;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known history of drug abuse that cannot be quit, mental disorders, alcoholism, drug abuse, or substance abuse;
- Known allergy to study drugs or excipients, known severe allergic reactions to any monoclonal antibody;
- As judged by the investigator, there are factors that seriously endanger the safety of the participants or other factors that may lead to the forced termination.
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
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100142
Rong Yu, MD, 13501147200, yurong311@aliyun.com
About this study
Official title: Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.
Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.
- Conditions
- SCLC, Extensive Stage, Immunotherapy, Chemotherapy, Radiotherapy
- Being tested
- First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLCDrug
Also called Adebrelimab
Cohort 1:
Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide.
Concurrent Radiotherapy Phase: the fourth cycle will incorporate concurrent radiotherapy along with atezolizumab and chemotherapy.
Maintenance Phase: Atezolizumab monotherapy will be administered until disease progression or intolerance by the patient, with atezolizumab being administered for a maximum duration of 2 years.
Cohort 2:
Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide.
Sequential Radiotherapy Phase: the fourth cycle will receive sequential radiotherapy in combination with atezolizumab.Final，Atezolizumab monotherapy will be continued until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | After three cycles of induction therapy with atezolizumab combined with carboplatin/cisplatin plus etoposide, patients who do not show progression will undergo immune-concurrent chemoradiotherapy and immune-sequential chemoradiotherapy, followed by maintenance therapy with atezolizumab until disease progression. Receives: Drug: First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
From the date of enrollment to the date of disease progression
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (2)
OS
from the date of enrollment until death by any cause or last follow-up
Measured: From date of enrollment to maximum of 2 years or death
Treatment-related adverse events
Treatment-related adverse events according to CTCAE 5.0.
Measured: Duration of treatment and follow up until death or 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start7 Jan 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies 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
- Model description
- Treatment Protocols for the Two Cohorts drug: Adebrelimab, Carboplatin/Cisplatin, Etoposide
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Yu, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768307
- Sponsor's protocol ID
- 2024YJZ108
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.
- ClinicalTrials.gov ID
- NCT06768307
- Acronym / sponsor ID
- 2024YJZ108
- Conditions
- SCLC, Extensive Stage, Immunotherapy, Chemotherapy, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Jan 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.
Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment Protocols for the Two Cohorts drug: Adebrelimab, Carboplatin/Cisplatin, Etoposide
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLCAfter three cycles of induction therapy with atezolizumab combined with carboplatin/cisplatin plus etoposide, patients who do not show progression will undergo immune-concurrent chemoradiotherapy and immune-sequential chemoradiotherapy, followed by maintenance therapy with atezolizumab until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years, no gender restrictions;
- Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a/b/c) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor/nodule size too large to be included in a tolerable radiation therapy plan;
- Participants have not received systemic treatment for extensive-stage SCLC;
- No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);
- ECOG performance status score of 0-2;
Key exclusion criteria (20 listed)
- Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other T-cell targeted drugs.
- Participants who have previously received chemoradiotherapy for limited-stage SCLC;
- Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size <1cm are allowed to be included);
- Participants with multiple liver metastases (isolated liver metastasis participants with metastasis <2cm can be included)
- Participants with spinal cord compression;
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 |
|---|---|---|
| First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLCAlso: AdebrelimabCohort 1: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Concurrent Radiotherapy Phase: the fourth cycle will incorporate concurrent radiotherapy along with atezolizumab and chemotherapy. Maintenance Phase: Atezolizumab monotherapy will be administered until disease progression or intolerance by the patient, with atezolizumab being administered for a maximum duration of 2 years. Cohort 2: Induction Phase: Patients will receive three cycles of atezolizumab in combination with carboplatin/cisplatin plus etoposide. Sequential Radiotherapy Phase: the fourth cycle will receive sequential radiotherapy in combination with atezolizumab.Final，Atezolizumab monotherapy will be continued until disease progression. | Drug | experimental group |
Primary outcome
PFS
Time frame: From enrollment to the end of treatment at 1 year
From the date of enrollment to the date of disease progression
2 secondary outcomes
OS
Time frame: From date of enrollment to maximum of 2 years or death
Treatment-related adverse events
Time frame: Duration of treatment and follow up until death or 90 days after enrollment
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes
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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 First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC in people with SCLC, Extensive Stage and Immunotherapy, 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 14 inclusion and 20 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 17 Aug 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 Rong Yu, MD (13501147200 ext. 010-88196687, yurong311@aliyun.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 enrollment to the end of treatment at 1 year). 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 17 Aug 2026.