eligibility_summary
Eligible: adults ≥18, ECOG 0–1, histologic NSCLC (squamous or non‑squamous), resectable cStage II–IIIB (N2 only), treated with 3–4 cycles PD‑1 + platinum doublet neoadjuvant therapy, complete R0 resection with lymph node dissection, and MPR/pathologic response assessed. Exclude: sublobar resection/no nodal dissection, off‑protocol postop therapy, ≥G3 irAEs, prior allogeneic transplant, ILD needing steroids, uncontrolled HTN, or active other cancers ≤5 years.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Multicenter phase II adjuvant study in resectable stage II–IIIB NSCLC patients without major pathologic response after neoadjuvant chemo-immunotherapy. Interventions and mechanisms: 1) Sintilimab: humanized anti-PD-1 monoclonal antibody blocking PD-1/PD-L1 to restore exhausted T-cell function. 2) LM-108 + Sintilimab: anti-CCR8 monoclonal antibody depleting CCR8+ tumor-infiltrating Tregs via ADCC to reprogram the tumor microenvironment, combined with PD-1 blockade. 3) IBI310 + Sintilimab: CTLA-4 monoclonal antibody plus PD-1 mAb for dual checkpoint blockade, enhancing T-cell priming and effector activity. 4) IBI363: PD-1/IL-2alpha bispecific fusion protein delivering CD25-biased IL-2 to PD-1+ T cells while blocking PD-1, preferentially expanding tumor-specific CD8+ T cells with reduced IL-2Rbeta/gamma toxicity. Targets/pathways: PD-1/PD-L1, CTLA-4/B7, CCR8+ Tregs (ADCC), IL-2/IL-2Ralpha, goal: reverse T-cell exhaustion and overcome ICI resistance.