eligibility_summary
Eligible: Adults (>=18) with metastatic squamous NSCLC, measurable lesion, ECOG 0-1, adequate organs (LDH <=2xULN), life >=3 mo, after progression on PD-1/PD-L1 + platinum >=12 wks or >=2 platinum cycles then PD-1/PD-L1 >=12 wks, combos with CTLA-4/LAG-3/TIGIT/VEGF allowed. Exclude: unresolved >G1 AEs, PD-1/PD-L1 <28d, steroids >10 mg within 7d, actionable EGFR/ALK/ROS1/HER2/MET/BRAF/RET/NTRK (KRAS ok), symptomatic brain mets/brain RT <14d, active GI disease, ILD/pneumonitis, infection needing IV antibiotics <14d, cardiac impairment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 3 randomized study in metastatic squamous NSCLC after PD‑1/PD‑L1 therapy. Interventions: 1) Gotistobart (ONC‑392/BNT316), a humanized IgG1 anti‑CTLA‑4 monoclonal antibody (checkpoint inhibitor). Mechanism: pH‑sensitive CTLA‑4 binding designed to preserve CTLA‑4 recycling in peripheral tissues (reducing immune toxicity) while retaining Fc‑mediated effector function to deplete intratumoral Tregs and enhance priming/expansion of tumor‑reactive T cells. Targets: CTLA‑4 on regulatory and activated T cells, modulates the CD28–CD80/86 costimulation axis on antigen‑presenting cells, boosting antitumor T‑cell responses. 2) Docetaxel, a taxane chemotherapy. Mechanism: stabilizes microtubules to inhibit mitosis and induce apoptosis. Targets: rapidly dividing tumor cells via microtubule dynamics.