A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513513-12-00

Acronym

INCB 54828-302

Enrollment

110

Registered

2024-08-22

Start date

2019-01-06

Completion date

2025-06-03

Last updated

2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Brief summary

PFS: defined as the time from date of randomization until date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first.

Detailed description

ORR (CR + PR): defined as the proportion of participants with best overall response of CR or PR per RECIST v1.1 as assessed by an ICR., OS: defined as the time from date of randomization until death due to any cause., DOR: defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first., DCR (CR + PR + SD): defined as the proportion of participants who achieved best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR., Occurrence of TEAEs and treatment-related AEs according to NCI CTCAE v5.0, physical findings, and vital sign, laboratory, and ECG changes., QoL questionnaire data (EQ-5D, EORTC QLQ-30, and BIL-21).

Interventions

DRUGPemazyre 9 mg tablets

DRUGPemazyre 13.5 mg tablets

DRUGPemazyre 4.5 mg tablets

DRUGGemcitabine 1000 mg

DRUGpowder for solution for infusion

DRUGCisplatin Ebewe 1 mg/ml – Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS: defined as the time from date of randomization until date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first.	—

Secondary

Measure	Time frame
ORR (CR + PR): defined as the proportion of participants with best overall response of CR or PR per RECIST v1.1 as assessed by an ICR., OS: defined as the time from date of randomization until death due to any cause., DOR: defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first., DCR (CR + PR + SD): defined as the proportion of participants who achieved best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR., Occurrence of TEAEs and treatment-related AEs according to NCI CTCAE v5.0, physical findings, and vital sign, laboratory, and ECG changes., QoL questionnaire data (EQ-5D, EORTC QLQ-30, and BIL-21).	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026