A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients with Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Sponsor: Voronoi Inc.
Phase: 1, 2
Disease: Advanced or metastatic EGFR-mutated non-small-cell lung cancer, EGFR C797X-resistant NSCLC, NSCLC with uncommon EGFR mutations
EU trial number: 2025-523122-40-00
Population: Adults (at least 18 years; 19 in Korea) with predominantly nonsquamous stage IIIB unresectable, stage IV or recurrent EGFR-mutated NSCLC, ECOG 0-1 and measurable extracranial disease. Phase Ia includes prior EGFR TKI-exposed participants, while Phase Ib includes biomarker-defined cohorts with common EGFR mutations, C797X resistance after third-generation TKI, and unusual mutations with or without previous EGFR treatment.
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