Unresectable CholangiocarcinomaPhase 3FIGHT-302NCT03656536
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
A Phase 3 study testing Pemigatinib, Gemcitabine and Cisplatin in people with Unresectable Cholangiocarcinoma and Metastatic Cholangiocarcinoma, run by Incyte Corporation at 215 sites in 19 countries.
Trial summary
The purpose of this study is 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma
- What is being tested?
- Pemigatinib, Gemcitabine and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 215 sitesin 19 countries
- Study dates
- 3 Jun 2019to 7 Jul 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).
- 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.
Who cannot join
- 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, or enrolled as of Amendment 6 (or Amendment 5-JP2) 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 ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).
- 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.
- Participant is 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.
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- 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).
- Significant gastrointestinal disorders 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 or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months.
- 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.
Trial locations and contacts
215 sites in 19 countries.
215 sites in 19 countries
United States36 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637-1447
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Karmanos Cancer Institute
Farmington Hills, Michigan, 48334
Summit Medical Group
Florham Park, New Jersey, 07932
Parkview Research Center
Fort Wayne, Indiana, 46845
Marin Cancer Care
Greenbrae, California, 94904
Greenville Hospital System University Medical Center Institute For Translational Oncology Research
Greenville, South Carolina, 29605
Houston Methodist Research Institute
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Mayo Clinic-Florida
Jacksonville, Florida, 32224
Comprehensive Cancer Centers of Nevada-Twain
Las Vegas, Nevada, 89169
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, 33140
West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
New Orleans, Louisiana, 70121
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Riverside Regional Medical Center
Newport News, Virginia, 23601
UC Irvine Medical Center
Orange, California, 92868-3201
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Providence Portland Med. Ctr
Portland, Oregon, 97213
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23229
Mayo Clinic
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
Georgetown University-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Aurora Research Institute
Wauwatosa, Wisconsin, 53226
The University of Kansas Cancer Center
Westwood, Kansas, 66205
White Plains Hospital
White Plains, New York, 10601
Japan31 sites
University of Tokyo Hospital
Bunkyō City, 113-8655
Chiba University Hospital
Chiba, 260-8677
Chiba Cancer Center
Chiba, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka, 812-8582
Hiroshima University Hospital
Hiroshima, 734-8551
Hyogo College of Medicine Hospital
Hyōgo, 663-8501
Kanazawa University Hospital
Ishikawa, 920-8641
Teikyo University Hospital
Itabashi-ku, 173-8606
Kobe University Hospital
Kobe, 650-0017
Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
Kyoto University Hospital
Kyoto, 606-8507
Nho Shikoku Cancer Center
Matsuyama, 791-0280
Kyorin University Hospital
Mitaka-shi, 181-8611
Aichi Cancer Center Hospital
Nagoya, 464-8681
Niigata Cancer Center Hospital
Niigata, 951-8566
Osaka International Cancer Institute
Osaka, 541-8567
Saitama Cancer Center
Saitama, 362-0806
Hokkaido University Hospital
Sapporo, 060-8648
Kindai University Hospital
Sayama, 589-8511
Tohoku University Hospital
Sendai, 980-8574
Jichi Medical University Hospital
Shimotsuke-shi, 329-0498
Keio University Hospital
Shinjuku-ku, 160-8582
Shizuoka Cancer Center
Shizuoka, 411-8777
Osaka University Hospital
Suita-shi, 565-0871
Toyama University Hospital
Toyama, 930-0194
Yamaguchi University Hospital
Ube, 755-8505
Wakayama Medical University Hospital
Wakayama, 641-8509
Yokohama City University Medical Center
Yokohama, 232-0024
Kanagawa Cancer Center
Yokohama, 241-8515
Oita University Hospital
Yufu-shi, 879-5593
Italy27 sites
Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60126
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, 70124
Ospedale Papa Giovanni Xxiii
Bergamo, 24127
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
Candiolo, 10060
Presidio Ospedaliero Garibaldi Nesima
Catania, 95100
Ospedale Degli Infermi - Faenza
Faenza, 48018
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, 16132
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, 20132
European Institute of Oncology
Milan, 20141
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133
A.O.U. Di Modena - Policlinico
Modena, 41124
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica
Naples, 80138
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
Orbassano, 10043
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
Presidio Ospedaliero Pescara
Pescara, 65124
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 00137
Istituto Nazionale Tumori Regina Elena Irccs
Roma, 00144
Universita Campus Bio Medico Di Roma
Rome, 00128
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152
Irccs Istituto Clinico Humanitas
Rozzano, 20089
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, 53100
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37134
San Bartolo Hospital
Vicenza, 36100
Germany22 sites
University Medical Center Rwth Aachen
Aachen, 52074
Charite - Campus Virchow-Klinikum
Berlin, 13353
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 13353
Universitatsklinikum Bonn Aoer
Bonn, 53127
Klinikum Bremen-Nord
Bremen, 28755
Universitatsklinikum Koln
Cologne, 50937
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307
Klinikum Der Johann Wolfgang Goethe University
Frankfurt am Main, 60590
University Medical Center Freiburg
Freiburg im Breisgau, 79106
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20246
Asklepios Klinik Altona
Hamburg, 22763
Hannover Medical School
Hanover, 30625
Universitaetsklinikum Des Saarlandes
Homburg / SAAR, 66421
Universitatsklinikum Leipzig Aor
Leipzig, 04103
Klinikum Ludwigsburg
Ludwigsburg, 71640
Otto-Von-Guericke-Universitat Magdeburg
Magdeburg, 39120
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131
University Hospital Grosshadern Munich
Munich, 81377
Klinikum Nuernberg
Nuremberg, 90419
Universitaetsklinikum in Tubingen
Tübingen, 72076
University Hospital Tuebingen
Tübingen, 72076
Universitatkinikums Ulm
Ulm, 89081
China20 sites
Peking Union Medical College Hospital
Beijing, 100032
West China Hospital Sichuan University
Chengdu, 610041
Fujian Cancer Hospital
Fuzhou, 350005
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangdong, 510000
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, 510000
Shulan Hangzhou Hospital Co Ltd
Hangzhou, 310000
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 310009
Heilongjiang Province Cancer Hospital
Harbin, 150081
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, 230001
Kunming 1St People'S Hospital
Kunming, 650032
Jiangsu Province Hospital
Nanjing, 210029
The Affiliated Hospital of Qingdao University
Shandong, 266071
Zhongshan Hospital Fudan University
Shanghai, 200032
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Xinhua Hospital
Shanghai, 200092
Sichuan Cancer Hospital
Sichuan, 610041
Tianjin Medical University Cancer Institute Hospital
Tianjin, 300060
Tongji Hospital Huazhong University of Science and Technology
Wuhan, 430030
Hubei Cancer Hospital
Wuhan, 430079
Northern Jiangsu Peoples Hospital
Yangzhou, 225001
France19 sites
Institut Sainte Catherine
Avignon, 84918
Chu Besancon Hospital Jean Minjoz
Besançon, 25030
Institut Bergonie
Bordeaux, 33076
Hopital Beaujon
Clichy, 92110
Chu de Limoges - Hospital Dupuytren
Limoges, 87042
Hopital Prive Jean Mermoz
Lyon, 69373
Chu Hopital de La Timone
Marseille, 13385
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
Centre Antoine Laccassagne
Nice, 06189
Hospital Universitaire Pitie-Salpetriere
Paris, 75013
Hopital Europeen Georges Pompidou (Hegp)
Paris, 75015
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
Pessac, 336600
Hospital de La Miletrie
Poitiers, 86021
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Rouen, 76031
University Hospital of Saint Etienne
Saint-Etienne, 42055
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44800
Chu Toulouse Hopital Rangueil
Toulouse, 31059
Chu Vandoeuvre-Les-Nancy Hopital Brabois
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
Spain14 sites
Hospital Materno Teresa Herrera
A Coruña, 15006
Hospital de La Santa Creu I Sant Pau
Barcelona, 08026
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinic Barcelona Main
Barcelona, 08036
Hospital Universitario Reina Sofia
Córdoba, 14004
HOSPITAL UNiVERSITARIO DONOSTIA
Donostia / San Sebastian, 20014
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario Hm Sanchinarro
Madrid, 28050
Hospital Regional Universitario de Malaga
Málaga, 29010
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
Hospital Universitari Parc Tauli
Sabadell, 08208
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital General Universitario de Valencia
Valencia, 46014
United Kingdom10 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Addenbrookes Hospital
Cambridge, CB2 0QQ
Velindre Cancer Centre
Cardiff, CF14 2TL
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX
The Royal Marsden Nhs Foundation Trust - Chelsea
London, SW3 6JJ
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
University College London Hospitals (Uclh)
London, WC1E 6BT
Kent Oncology Centre - Maidstone Hospital
Maidstone, ME16 9QQ
The Christie Nhs Foundation Trust
Manchester, M20 4BV
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT
Belgium7 sites
Ulb Hospital Erasme
Brussels, 01070
Universitair Ziekenhuis Brussel
Brussels, 01090
Universitair Ziekenhuis Gent
Ghent, 09000
Hospital de Jolimont
Haine-st-paul, 07100
Az Groeninge Campus Kennedylaan
Kortrijk, 08500
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, 05530
Austria6 sites
Landeskrankenhaus Universitatsklinikum Graz
Graz, 08036
Innsbruck University Hospital
Innsbruck, A-6020
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 04010
Salzburger Universitatsklinikum
Salzburg, 05020
Landeskrankenhaus Steyr
Steyr, 04400
Allgemeines Krankenhaus Der Stadt Wien
Vienna, 01090
Canada5 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Nova Scotia Health Authority/Qeii Health Sciences Centre
Halifax, Nova Scotia, B3H 4K4
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Center
Toronto, Ontario, MG5 2M9
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9
Israel5 sites
Soroka University Medical Center
Beersheba, 84001
Rambam Health Care Campus
Haifa, 3109601
Hadassah University Hospital
Jerusalem, 9112001
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Netherlands4 sites
Amsterdam University Medical Centre
Amsterdam, 1100 DD
Maastricht Umc+
Maastricht, 6202 AZ
Erasmus Medical Center
Rotterdam, 3015 CE
Umc Utrecht
Utrecht, 3584 CX
Finland3 sites
Docrates Cancer Center
Helsinki, 00180
Helsinki University Central Hospital
Helsinki, 00290
Tampere University Hospital
Tampere, 33521
Switzerland2 sites
Inselspital - Universitaetsspital Bern
Bern, 03010
Universitatsspital Zurich
Zurich, 08091
About this study
Official title: 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)
The purpose of this study is 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.
- Being tested
- Pemigatinib, Gemcitabine, Cisplatin
- Keywords
- Cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR, FGFR rearrangement
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
GemcitabineDrug
Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
CisplatinDrug
Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pemigatinib | Experimental | Not described Receives: Drug: Pemigatinib |
| Gemcitabine + Cisplatin | Active comparator | Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib. Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized Treatment Period: Progression-free Survival (PFS)
PFS was defined as the time from the date of randomization until the date of disease progression (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] and assessed by an Independent Central Review [ICR]) or death, whichever occurs first.
Measured: up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
PFS was defined as the time from the date of randomization until the date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Measured: up to 1422 days
Transition Period: PFS
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause.
Measured: up to 1496 days
Transition Period: Kaplan-Meier Estimates of PFS of the Indicated Lengths of Time
PFS was defined as the time from the date of the first dose of study drug after transition until the earliest date of progressive disease or death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Measured: up to 1496 days
Secondary outcomes (17)
Randomized Treatment Period: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 1422 days
Transition Period: ORR
ORR was defined as the percentage of participants with a best overall response of CR or PR per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Measured: up to 1496 days
Randomized Treatment Period: Overall Survival
Overall survival was defined as the time from the date of randomization until death due to any cause.
Measured: up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of Overall Survival of the Indicated Lengths of Time
Overall survival was defined as the time from the date of randomization until death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Measured: up to 1422 days
Randomized Treatment Period: Duration of Response (DOR)
DOR was 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 occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Measured: up to 1422 days
Randomized Treatment Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
DOR was 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 occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
Measured: up to 1422 days
Transition Period: DOR
DOR was 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 occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Measured: up to 1496 days
Transition Period: Kaplan-Meier Estimates of DOR of the Indicated Lengths of Time
DOR was 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 occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start.
Measured: up to 1496 days
Randomized Treatment Period: Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Measured: up to 1422 days
Transition Period: DCR
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or SD per RECIST v1.1 as assessed by an ICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Measured: up to 1496 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
Measured: up to 1457 days
Number of Participants With Any Treatment-related TEAE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug for participants who did not transition to pemigatinib. For participants who transitioned to pemigatinib, the end date was 30 days after the last dose date of gemcitabine plus cisplatin or the day before the first dose of pemigatinib after transition, whichever occurred first.
Measured: up to 1457 days
Transition Period: Number of Participants With Any TEAE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
Measured: up to 1531 days
Transition Period: Number of Participants With Any Treatment-related TEAE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE for the Crossover Evaluable Population was any AE either reported for the first time or for a worsened pre-existing event after the first dose of pemigatinib after switch and until 30 days after the last dose of pemigatinib.
Measured: up to 1531 days
Randomized Treatment Period: Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) Scores at Early Termination
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1422 days
Randomized Treatment Period: Change From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Including 21 Questions Specific to the Biliary System (EORTC QLQ-BIL21) at Early Termination
The EORTC QLQ-BIL21 assessed QoL across 8 scales: eating, jaundice, tiredness, pain, anxiety, treatment side effects, drains, and weight loss. The raw score of each scale is the mean of the item values that contribute to the scale, and the standardized score is a linear transformation of the raw score so that the range is from 0 to 100. A high score for a symptom scale represents a high level of symptomatology/problems. The BIL21 questionnaire was only be administered to participants for whom the questionnaire is validated in that language. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; up to 1422 days
Randomized Treatment Period: Number of Participants With the Indicated Responses on the European Quality of Life 5 Dimensions (3 Levels) Questionnaire (EQ-5D [3L])
The EQ-5D (3L) is the descriptive system that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Measured: Baseline; up to 1422 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start3 Jun 2019
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unresectable CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656536
- Sponsor's protocol ID
- INCB 54828-302
- Other IDs
- 2024-513513-12-00, 2018-002894-23, 2018
- Acronym
- FIGHT-302
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2018
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Publications
Bekaii-Saab TS, Melisi D, Wilmink H, Garufi C, Tran N, Tortora G, De Braud F, Frodin JE, Lonardi S, Lin E, Babiker H, Lin B, Fornaro L, Munoz Martin A, Bridgewater J, Knox JJ, De Vos-Geelen J, Scott-Brown M, Veronese L, Ioannidis S, Gilmartin A, Janik JE, Guo Y, Furuse J, Ioka T, Rimassa L, Vogel A. Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase III FIGHT-302 Trial. J Clin Oncol. 2026 Jun 1:JCO2600788. doi: 10.1200/JCO-26-00788. Online ahead of print.
PubMed 42223137Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.
PubMed 32677452