FIGHT-302

NCT03656536 📎

Regimen

Experimental
Pemigatinib 13.5 mg PO QD (2 weeks on/1 week off) vs gemcitabine 1000 mg/m² + cisplatin 25 mg/m² IV d1,8 q21d up to 8 cycles
Control
Gemcitabine + cisplatin (standard first-line chemotherapy doublet)

Population

First-line unresectable or metastatic CCA with FGFR2 fusion or rearrangement by central testing; ICC-dominant by definition given FGFR2 biology. PMID 32677452 is the protocol/design paper (Future Oncol 2020); primary efficacy results had not been published in a peer-reviewed journal as of April 2026 (ESMO 2024 oral presentation showed positive PFS; full JCO/LO publication pending).

Key finding

FIGHT-302 is the phase 3 confirmatory trial for first-line pemigatinib in FGFR2-rearranged CCA. ESMO 2024 data presented by Bekaii-Saab showed significant improvement in PFS vs GemCis; full PFS and OS data with confidence intervals are not yet in a peer-reviewed publication as of April 2026. If positive, this will establish pemigatinib as a biomarker-selected 1L standard and potentially replace GemCis for FGFR2+ ICC. The pmid cited here is the protocol publication (Future Oncol 2020); the primary results PMID should be updated once published.

Source: PMID 32677452

Timeline

    Guideline citations

    • NCCN BTC (p.35)