Table Info

Table 2.

Ongoing first-line phase III trials with targeted agents for advanced BTCs

Study name/number	Target population	Estimated sample size	Experimental treatment	Comparator	Primary endpoint	Secondary endpoints
FIGHT-302¹ NCT03656536	FGFR2 rearrangements	432 patients	Pemigatinib 13.5 mg QD on a 3-week cycle	Cisplatin 25 mg/mq + gemcitabine 1000 mg/mq on days 1 and 8 q3w up to 8 cycles	PFS per RECIST v1.1 by ICR	OS, ORR, DOR, DCR per RECIST v1.1 by ICR, safety, QoL
PROOF trial NCT03773302	FGFR2 fusions	384 patients	Infigratinib 125 mg orally QD, 3 weeks on, 1 week off	Cisplatin 25 mg/mq + gemcitabine 1000 mg/mq on days 1 and 8 q3w up to 8 cycles	PFS per RECIST v1.1 by ICR	OS, ORR, DOR, BOR, DCR per RECIST v1.1 by ICR, PFS per investigator assessment, safety
FOENIX-CCA3¹ NCT04093362	FGFR2 rearrangements	216 patients	Futibatinib 20 mg orally QD on a 3-week cycle	Cisplatin 25 mg/mq + gemcitabine 1000 mg/mq on days 1 and 8 q3w up to 8 cycles	PFS per RECIST v1.1 by ICR	OS, ORR, DCR per RECIST v1.1 by ICR, PFS per investigator assessment, safety

Crossover is allowed in FIGHT-302 and FOENIX-CCA3; QD: once a day; q3w: every 3 weeks; ICR: independent central review; QoL: quality of life; BOR: best overall response

Declarations

Author contributions

MGP, LR, AC, AD and VZ contributed to conception and design of the work. All authors wrote the manuscript, contributed to manuscript revision, read and approved this submitted version.

Conflicts of interest

LR received consulting fees from Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi, Servier, Zymeworks; lecture fees from AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, Roche, Sanofi; travel expenses from Ipsen; and institutional research funding from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks. The other authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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