Eligibility criteria
FGFR2 fusions (central lab or local lab with tissue for central confirmation)
ECOG PS ≤ 1
No prior treatment for nonresectable, recurrent, or metastatic disease (prior [neo]adjuvant treatment permitted)
Randomize
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Infigratinib monotherapy (125 mg once daily × 21 days every 28 days continuously)
Cisplatin (25 mg/m ) + Gemcitabine (1000 mg/m on days 1, 8 every 21 days)
Crossover to infigratinib permitted after central confirmation of radiographic PD on cisplatin + gemcitabine
Primary endpoint: PFS (central)
Secondary endpoints: OS, local PFS, ORR, quality of life, safety, pharmacokinetics
N ~ 384
2:1
NCT03773302
2
2