Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Adebelizumab with chemotherapy given with radiotherapy at the same time versus after radiotherapy for extensive-stage small cell lung cancer

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).

Run by Peking University Cancer Hospital & Institute · NCT06768307 · Data updated 2026-11-12

This study tests whether adding adebelizumab to chemo and radiotherapy works better when given at the same time as radiotherapy compared to after radiotherapy in adults with extensive-stage SCLC.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorPeking University Cancer Hospital & Institute
Academic / other
Drugs / interventionsAdebrelimab, radiation, prednisone, adebelizumab, chemotherapy, Immunotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 7, 2025
Main results expectedJanuary 31, 2027
Study endsJanuary 31, 2028
Registry record updatedAugust 17, 2026
Trial IDNCT06768307 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with untreated extensive-stage SCLC, up to 5 lesions, at least one measurable lesion, ECOG 0-2, life expectancy ≥3 months, and suitable organ function.

Probably not a fit

Patients with more than 5 lesions, poor performance status, or contraindications to immunotherapy or radiotherapy may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial for adults with extensive-stage small cell lung cancer. Participants receive upfront immunotherapy (adebelizumab) with chemotherapy and radiotherapy, compared between concurrent radiotherapy or sequential radiotherapy schedules. The study aims to see which timing strategy improves outcomes while monitoring safety. Eligible patients have untreated ES-SCLC, good performance status, and limited number of metastatic lesions. The trial is led by Peking University Cancer Hospital & Institute in Beijing, with no listed collaborators.

Why it matters

Potential benefit: If successful, the approach could improve response and survival while clarifying optimal timing of radiotherapy with immunochemotherapy for ES-SCLC.

How similar studies have gone: Previous research suggests combining immunotherapy with radiotherapy can be beneficial, but the best timing (concurrent vs sequential) remains under investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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;
* 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.

Where it's running

  • Peking University Cancer Hospital and Institute
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.