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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

NCT03656536 · FIGHT-302 Phase 3Terminated

Lead sponsor
Incyte Corporation (Industry)
Enrollment
167 (actual)
Start date
3 Jun 2019
Primary completion
7 Jul 2025 (actual)
Study completion
7 Jul 2025
Last update posted
11 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • Pemigatinib Drug
  • Gemcitabine Drug
  • Cisplatin Drug

Conditions and primary outcome

  • Unresectable Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma

Primary outcome

Randomized Treatment Period: Progression-free Survival (PFS) (up to 1422 days); Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time (up to 1422 days); Transition Period: PFS (up to 1496 days); Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time (up to 1496 days)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03656536 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Randomized Treatment Period: Progression-free Survival (PFS)

    Time frame
    up to 1422 days
    Measure
    Median
    Unit
    months

    • Pemigatinib 13.5 mg QD vs Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QDSuperiority

      Estimate
      0.58Hazard Ratio (HR)
      95% CI, two-sided
      0.39 to 0.87
      p-value
      0.0078
      Method
      Log Rank

Serious adverse events

Time frame: up to approximately 6 years

Participants with serious adverse events per group for FIGHT-302, as posted
GroupAffectedAt risk
Randomized Period: Pemigatinib 13.5 mg QD2383
Randomized Period: Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^21773
Transition Period: Pemigatinib 13.5 mg QD942

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase III FIGHT-302 Trial.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 Aug 10

    PubMed 42223137 (opens in a new tab)DOI 10.1200/JCO-26-00788 (opens in a new tab)

  2. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements.

    Future oncology (London, England) · 2020 Oct

    PubMed 32677452 (opens in a new tab)DOI 10.2217/fon-2020-0429 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.