Adebrelimab with concurrent chemoradiotherapy: 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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.
Primary outcome measure(s)
PFS — 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
Trial sites (1)
Facility
City
Region
Status
Peking University Cancer Hospital and Institute
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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