eligibility_summary
Adults (≥18) with metastatic/unresectable NSCLC, progressed after PD-(L)1, platinum chemo and targeted therapy if indicated (or ineligible/refuse), known STK11/LKB1 mutation, ECOG 0–1, adequate organ/marrow function, consent and contraception. Exclude: uncontrolled illness, O2-dependent, severe COPD/asthma, major CV disease/QTc>480, recent therapy/radiation/investigational drug, untreated brain/leptomeningeal mets, other active cancers, HBV/HCV active, HIV+, prior daratumumab, pregnancy, recent surgery, live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm Phase 2 of subcutaneous daratumumab/hyaluronidase (DARZALEX Faspro) in previously treated metastatic NSCLC with STK11/LKB1 mutations. Interventions/mechanisms: Daratumumab is a human IgG1κ monoclonal antibody targeting CD38 (cell-surface ectoenzyme). It mediates tumor/immune-cell killing via Fc-dependent ADCC and ADCP, complement-dependent cytotoxicity (CDC), and apoptosis, and remodels the tumor microenvironment by depleting CD38+ immunosuppressive cells. Hyaluronidase-fihj is recombinant human hyaluronidase that enhances SC absorption (no anti-cancer activity). Targets: CD38-expressing cells, including plasma cells and subsets of NK, T, B, and myeloid cells (e.g., MDSCs, Tregs), impacting Fcγ receptor and complement pathways and the CD38 ectoenzyme (NAD+/adenosine-associated) axis.