eligibility_summary
Inclusion: metastatic NSCLC, EGFR/ALK−, no prior metastatic therapy (prior non‑metastatic therapy allowed if relapse >6 mo), measurable disease, ECOG 0–1, ≥18, adequate organ function, contraception. Exclusion: prior CTLA‑4/PD‑(L)1, systemic steroids/immunosuppression, major CV disease or QTcF>480, unresolved ≥G2 AEs, untreated/unstable brain mets, other active cancer <2 y (except low‑risk), ILD/pneumonitis, uncontrolled HIV or active HBV/HCV/TB, ≥G3 neuropathy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06322108 evaluates two immune checkpoint inhibitors in first‑line metastatic NSCLC: botensilimab (AGEN1181), an Fc‑engineered human IgG1 monoclonal antibody targeting CTLA‑4, and balstilimab (AGEN2034), a human monoclonal antibody targeting PD‑1. Mechanisms: botensilimab blocks CTLA‑4 to enhance T‑cell priming/expansion and, via its engineered Fc, may deplete intratumoral regulatory T cells, balstilimab blocks PD‑1 to reinvigorate exhausted effector T cells and restore anti‑tumor function. Targeted cells/pathways: CTLA‑4/CD80‑CD86 checkpoint on T cells/Tregs, PD‑1/PD‑L1 axis on activated T cells and tumor/immune cells, boosting CD8+ cytotoxic responses. Design: single‑arm Phase II, dosing botensilimab 75 mg IV q6w (≤4 doses) + balstilimab 240 mg IV q2w.