eligibility_summary
Adults (>=18) with stage IV NSCLC, measurable disease, completed 3-4 cycles chemo-immunotherapy with pembrolizumab in >=3, no progression, <=2 maintenance cycles and eligible to continue. Need ECOG 0-1, biopsy-accessible site, survival >6 mo, adequate labs, off steroids >=28 d. Exclude cardiac disease, active brain mets, rhuGM-CSF contraindication, autoimmune on immunosuppression, recent malignancy, concurrent trials, pregnancy/breastfeeding, actionable drivers unless ineligible/progressed.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: STEMVAC, an intradermal plasmid DNA cancer vaccine encoding Th1-biased polyepitopes from CDH3 (P-cadherin), CD105 (endoglin), YB-1, MDM2, and SOX2, plus sargramostim (recombinant human GM-CSF cytokine adjuvant), vs sargramostim alone. Mechanisms: DNA uptake drives in situ expression of antigen fragments, processing and MHC I/II presentation, priming CD8+ cytotoxic T cells and CD4+ Th1 responses against NSCLC cells, GM-CSF recruits and activates dendritic cells, monocytes/macrophages to enhance antigen presentation. Targets/pathways: tumor stemness and transcriptional programs (SOX2, YB-1), p53 regulation (MDM2), adhesion/EMT (CDH3), angiogenesis/TGF-β signaling (CD105), and immune activation via APCs and CTLs. Population: stage IV NSCLC on maintenance pembrolizumab ± pemetrexed.