NCT03656536 (FIGHT-302) is a Phase 3 clinical trial of Pemigatinib in Unresectable Cholangiocarcinoma, sponsored by Incyte Corporation.

Who is sponsoring NCT03656536?

NCT03656536 is sponsored by Incyte Corporation.

What drugs are being tested in NCT03656536?

Interventions in NCT03656536: Pemigatinib, Gemcitabine, Cisplatin.

What condition does NCT03656536 study?

NCT03656536 studies Unresectable Cholangiocarcinoma, Metastatic Cholangiocarcinoma.

Is NCT03656536 still recruiting?

NCT03656536 is currently terminated. Last updated 24 August 2025.

Last reviewed 2025-08-24 · How we verify

NCT03656536: FIGHT-302

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 24 August 2025

What this trial tests

Phase 3 trial testing Pemigatinib in Unresectable Cholangiocarcinoma in 167 participants. Terminated before completion.

Timeline

3 June 2019

Primary endpoint
7 July 2025

7 July 2025

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	167
Start date	3 June 2019
Primary completion	7 July 2025
Estimated completion	7 July 2025
Sites	215 locations across Italy, Finland, Japan, Ireland, Denmark, Netherlands, Belgium, Sweden

Drugs / interventions tested

Pemigatinib (PEMIGATINIB) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →
Cisplatin (cisplatin) — full drug profile →

Conditions studied

Unresectable Cholangiocarcinoma — all drugs for Unresectable Cholangiocarcinoma →
Metastatic Cholangiocarcinoma — all drugs for Metastatic Cholangiocarcinoma →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Unresectable Cholangiocarcinoma or Metastatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cholangiocarcinoma 2020: the next horizon in mechanisms and management.
Banales JM, Marin JJG, Lamarca A, Rodrigues PM, et al · · 2020 · cited 1826× · PMID 32606456 · DOI 10.1038/s41575-020-0310-z
Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study.
Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, et al · · 2020 · cited 1175× · PMID 32203698 · DOI 10.1016/s1470-2045(20)30109-1
Angiogenic signaling pathways and anti-angiogenic therapy for cancer.
Liu ZL, Chen HH, Zheng LL, Sun LP, et al · · 2023 · cited 808× · PMID 37169756 · DOI 10.1038/s41392-023-01460-1
Fibroblast growth factor receptors in cancer: genetic alterations, diagnostics, therapeutic targets and mechanisms of resistance.
Krook MA, Reeser JW, Ernst G, Barker H, et al · · 2021 · cited 244× · PMID 33268819 · DOI 10.1038/s41416-020-01157-0
FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies.
Subbiah V, Iannotti NO, Gutierrez M, Smith DC, et al · · 2022 · cited 157× · PMID 35176457 · DOI 10.1016/j.annonc.2022.02.001
Cholangiocarcinoma - novel biological insights and therapeutic strategies.
Ilyas SI, Affo S, Goyal L, Lamarca A, et al · · 2023 · cited 156× · PMID 37188899 · DOI 10.1038/s41571-023-00770-1
FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with <i>FGFR2</i> rearrangements.
Bekaii-Saab TS, Bekaii-Saab TS, Valle JW, Van Cutsem E, et al · · 2020 · cited 142× · PMID 32677452 · DOI 10.2217/fon-2020-0429
FGFR Fusions in Cancer: From Diagnostic Approaches to Therapeutic Intervention.
De Luca A, Esposito Abate R, Rachiglio AM, Maiello MR, et al · · 2020 · cited 87× · PMID 32962091 · DOI 10.3390/ijms21186856

Verify or expand the search:

Other trials of Pemigatinib

Trials testing the same drug.

NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta · Phase 2 · recruiting
NCT06653777 — Efficacy of Pemigatinib in Patients With Solid Tumors Characterized by an Alteration of the Gene FGFR in Tumor Cells · Phase 2 · recruiting
NCT06439485 — Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarc · Phase 1, PHASE2 · recruiting
NCT06551896 — Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor · Phase 2 · not yet recruiting
NCT06389799 — A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) · Phase 2 · recruiting

Other recruiting trials for Unresectable Cholangiocarcinoma

Currently open trials in the same condition.

NCT04378023 — Liver Transplant Combined With Neoadjuvant Chemo-radiotherapy in the Treatment of Unresectable Hilar Cholangiocarcinoma. · recruiting
NCT04175912 — Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver · Phase 2 · active not recruiting

Other Incyte Corporation trials

Trials by the same sponsor.

NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03656536 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 24 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03656536.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing