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)

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) - INCB54828-302 (FIGHT-302)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52434

Enrollment

Registered

2019-04-17

Start date

2020-04-06

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Bile duct cancer Cholangiocarcinoma

Interventions

• Treatment Group A: Pemigatinib (13.5 mg per day) administered as continuous therapy schedule (a cycle is 3 weeks). • Treatment Group B: Gemcitabine (1000 mg/m2) plus cisplatin (25 mg/m2) administ

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Male and female participants at least 18 years of age at the time of signing the ICF; a legally minor participant from Japan needs written parental consent. 3. Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the AJCC Cancer Staging Manual [AJCC 2010]). 4. Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria. 5. ECOG performance status 0 to 1. 6. Documented FGFR2 rearrangement.

Exclusion criteria

Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neoadjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and

Design outcomes

Primary

Measure	Time frame
Progression Free Survival: 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
• Overall Response rate (complete response(CR) + Partial Response(PR)): defined as the proportion of participants with best overall response of CR or PR per RECIST v1.1 as assessed by an ICR. • Overall Survival: defined as the time from date of randomization until death due to any cause.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)