A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)

Inclusion Criteria:

- Male and female participants at least 18 years of age at the time of signing the
informed consent form (ICF); a legally minor participant from Japan needs written
parental consent.

- Histologically or cytologically confirmed cholangiocarcinoma that is previously
untreated and considered unresectable and/or metastatic (Stage IV per the American
Joint Committee on Cancer (AJCC) Cancer Staging Manual).

- Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1
criteria.

- Eastern Cooperative Oncology Group performance status 0 to 1.

- Documented FGFR2 rearrangement.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Received prior anticancer systemic therapy for unresectable and/or metastatic disease
(not including adjuvant/neo-adjuvant 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).

- Child-Pugh B and C.

- Toxicities related to prior therapy(ies) must be Common Terminology Criteria for
Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.

- Concurrent anticancer therapy, other than the therapies being tested in this study.

- Must not be a candidate for potentially curative surgery.

- Current evidence of clinically significant corneal (including but not limited to
bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and
keratoconjunctivitis) or retinal disorder (including but not limited to central serous
retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment)
as confirmed by ophthalmologic examination.

- Radiation therapy administered within 4 weeks of enrollment/randomization/first dose
of study treatment.

- Known central nervous system (CNS) metastases or history of uncontrolled seizures.

- Known additional malignancy that is progressing or requires active treatment
(exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or
in situ cervical cancer that has undergone potentially curative therapy).

- Laboratory values at screening outside the protocol-defined range.

- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance
with ectopic calcification of soft tissues (exception: commonly observed
calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to
injury, disease, and aging, in the absence of systemic mineral imbalance).

- Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal
pH that could interfere with absorption, metabolism, or excretion of pemigatinib.

- Clinically significant or uncontrolled cardiac disease.

- History or presence of an abnormal ECG, which, in the investigator's opinion, is
clinically meaningful.

- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal or antiviral treatment within 2 weeks prior to enrollment.

- Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14
days or 5 half-lives (whichever is longer) before the first dose of study treatment.
Note: Moderate CYP3A4 inhibitors are not prohibited

- Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or
their excipients.

- Inadequate recovery from toxicity and/or complications from a major surgery before
starting therapy.