eligibility_summary
Eligible: resectable stage II-IIIB (N2) NSCLC, ECOG 0-1, no activating EGFR mutations, HIV controlled on ART, HBV on therapy with undetectable load, HCV RNA undetectable, and no pCR after neoadjuvant chemo+pembrolizumab plus surgery. Exclude: SCLC/mixed small cell, large-cell neuroendocrine, sarcomatoid, Pancoast, ALK+, prior neoadjuvant/IO/other systemic therapy, cancer vaccine, recent RT (<2 wks) or steroid toxicity, live vaccine <30 days.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06623422 tests adjuvant pembrolizumab ± intismeran autogene (V940/mRNA‑4157) in resectable stage II–IIIB NSCLC after neoadjuvant pembrolizumab + platinum doublet chemo and surgery. Interventions/mechanisms (type): • Pembrolizumab (MK‑3475, monoclonal antibody, IgG4 checkpoint inhibitor): blocks PD‑1 on T cells from binding PD‑L1/PD‑L2, restoring antitumor T‑cell activity. • Intismeran autogene V940 (personalized mRNA cancer vaccine): encodes patient‑specific tumor neoantigens, taken up by antigen‑presenting cells, translated and presented on MHC I/II to prime/expand CD8+ and CD4+ T cells. • Neoadjuvant chemo: cisplatin/carboplatin (platinum DNA crosslinkers), pemetrexed (antifolate antimetabolite), gemcitabine (nucleoside analog), paclitaxel (taxane microtubule stabilizer). Target cells/pathways: PD‑1/PD‑L1/PD‑L2 checkpoint on T cells/tumor/myeloid cells, dendritic cell antigen presentation and T‑cell priming, tumor DNA replication/repair and microtubules. Placebo IM in control arm.