NAPOLI-3

NCT04083235 📎

Regimen

Experimental
NALIRIFOX: liposomal irinotecan 50 mg/m2 + oxaliplatin 60 mg/m2 + leucovorin 400 mg/m2 + 5-FU 2400 mg/m2 46h infusion, q2w.
Control
Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 d1, 8, 15 q4w (MPACT schedule).

Population

Treatment-naive metastatic PDAC, ECOG PS 0-1, global multicenter (187 sites, 18 countries).

Key finding

NAPOLI-3 is the first trial in a decade to beat nab-pac+gem in the 1L metastatic space. NALIRIFOX became a new preferred 1L option per NCCN 2024 for fit patients and was FDA-approved February 2024. The triplet partially substitutes for FOLFIRINOX in regions where lipo-IRI is accessible.

Source: PMID 37708904

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.64)