Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC

Laborértékek

• 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.

• 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.