# FIGHT-302

Source: https://onco.cc/trials/fight-302/  
OnCo record `fight-302` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

FIGHT-302 set out to test whether the FGFR2 inhibitor pemigatinib should be used before chemotherapy in bile duct cancers driven by an FGFR2 fusion; the trial closed early after the standard of care changed, and its 2026 report showed pemigatinib delayed progression compared with chemotherapy, with similar overall survival.

## Summary

Pemigatinib was approved in 2020 for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement on the single-arm FIGHT-202 study. FIGHT-302 was the confirmatory phase 3 trial, randomising patients with untreated, unresectable or metastatic FGFR2-rearranged cholangiocarcinoma to pemigatinib or to gemcitabine and cisplatin, with progression-free survival as the primary endpoint.

The trial closed early after a change in standard of care, having randomised 167 patients. The 2026 report in the Journal of Clinical Oncology showed median progression-free survival of 8.3 months with pemigatinib against 6.8 months with chemotherapy (hazard ratio 0.58), an objective response rate of 47 percent against 15 percent, and similar overall survival (24.4 against 25.0 months), so pemigatinib delays progression in the first line but the truncated trial could not show a survival advantage.

## Fields

- Kind: Trial
- Status: withdrawn
- Last checked: 2026-09-22
- Tags: subtype-trials
- Registry id: NCT03656536
- Phase: 3
- Setting: Untreated advanced cholangiocarcinoma with an FGFR2 rearrangement: pemigatinib against gemcitabine and cisplatin
- Sponsor: Incyte
- Enrolled: 167
- Outcomes: Progression-free survival: Pemigatinib 8.3 months vs Gemcitabine + cisplatin 6.8 months, HR 0.58; Objective response rate: Pemigatinib 47% vs Gemcitabine + cisplatin 15%; Duration of response: Pemigatinib 14.2 months vs Gemcitabine + cisplatin 6.3 months; Overall survival: Pemigatinib 24.4 months vs Gemcitabine + cisplatin 25 months

## Notes

- Registry status on 22 September 2026: Terminated (registry record last updated 11 August 2026; primary completion reached 7 July 2025). Why stopped, in the sponsor's words: The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision.

## Sources

- ClinicalTrials.gov NCT03656536: https://clinicaltrials.gov/study/NCT03656536

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Pemigatinib](https://onco.cc/drugs/pemigatinib/)
- companies: [Incyte](https://onco.cc/companies/incyte/)
- people: [Tanios Bekaii-Saab](https://onco.cc/people/tanios-bekaii-saab/)
- ideas: [ctDNA-guided switching among FGFR inhibitors](https://onco.cc/ideas/idea-btc-ctdna-fgfr-resistance/)

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