eligibility_summary
Adults >=18 with stage IIIB-IV NSCLC, EGFR Ex20ins+ (accredited), >=1 measurable lesion (non-brain), ECOG 0-1, life expectancy >=12 wks, no prior systemic therapy (adjuvant/neoadjuvant >6 mo ok). Exclude: prior ex20ins EGFR TKI, recent antitumor meds, immunosuppressants, metformin or strong CYP3A4 meds, recent major surgery/RT, active CNS disease, unresolved tox >Gr1, recent TE/bleeding, serious cardiac, QTcF>470, uncontrolled HTN, GI absorption, allergy, pregnancy, live vax <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, first-line study in advanced non-squamous NSCLC with EGFR exon 20 insertions. Interventions: (1) PLB1004 monotherapy—an oral small-molecule EGFR tyrosine kinase inhibitor designed to selectively inhibit EGFR exon 20 insertion mutants, suppressing downstream signaling (MAPK/ERK, PI3K-AKT) in tumor cells. (2) Comparator: pemetrexed (antifolate antimetabolite inhibiting thymidylate synthase and other folate-dependent enzymes) plus carboplatin or cisplatin (DNA cross-linking platinum chemotherapies) with optional sintilimab (anti–PD-1 monoclonal antibody immunotherapy restoring T-cell antitumor activity). Targets: EGFR-mutant tumor cells, DNA synthesis/repair pathways, PD-1 pathway on T cells.