Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration (FIGHT-210)

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced Non-Small Cell Lung Cancer With an FGFR Alteration Who Progressed on Previous Therapy (FIGHT 210)

This is an open-label, single arm study to study the safety, efficacy and tolerability of Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatment options

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Pemigatinib

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille Cedex 5, France, 13385
    • H�PITAL NORD - CHU MARSEILLE
  • Toulouse, France, 31000
    • Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Immenhausen, Germany, 34376
    • LKI Lungenfachklinik Immenhausen
  • Mannheim, Germany, 68167
    • University Hospital Mannheim
• Italy
  • Aviano, Italy, 33081
    • IRCCS Centro di Riferimento Oncologico
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • Meldola, Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
  • Orbassano, Italy, 10043
    • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
  • Perugia, Italy, 06132
    • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena IRCCS
  • Rozzano, Italy, 20089
    • Irccs Istituto Clinico Humanitas
• Spain
  • A Coru?a, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08035
    • Hospital General Universitario Vall D Hebron
  • Girona, Spain, 17007
    • Ico Girona Hospital Universitari de Girona Dr Josep Trueta
  • Jaen, Spain, 23007
    • Hospital Universitario Ciudad de Jaen
  • L'hospitalet de Llobregat, Spain, 08908
    • Ico Institut Catala D Oncologia
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28046
    • Hospital Universitario de La Paz
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• United States
  • California
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists & Research Institute
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Healthcare System
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Hospital
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Spoknwrd Clinical Trials Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed advanced or metastatic NSCLC (Stage IIIB/C or IV per the AJCC Cancer Staging Manual, 8th Edition). Both squamous and nonsquamous NSCLC are eligible.
• Radiographically measurable disease (per RECIST v1.1). Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
• Documentation of known/likely actionable known or likely FGFR1-3 alterations.
• Must have objective documented progression after at least 1 prior therapy, and must have no therapy available that is likely to provide clinical benefit. Participants who are intolerant of or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
• ECOG performance status of 0 to 2.
• Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
• Willingness to avoid pregnancy or fathering a child.

Exclusion Criteria

• Prior receipt of a selective FGFR inhibitor.
• Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before the first dose of pemigatinib. Participants must have recovered (≤ Grade 1 as per CTCAE v5.0 or at pretreatment baseline) from AEs from previously administered therapies (excluding alopecia).
• Concurrent anticancer therapy (eg, chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or investigational therapy).
• 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 macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.
• Radiation therapy administered for the treatment of cancer lesions within 2 weeks before enrollment/first dose of study drug. Participants must have recovered from all radiation related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 1-week washout is permitted for palliative radiation to non-CNS disease.
• Untreated brain or CNS metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). Participants who have previously treated and clinically stable brain or CNS metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and if they are on a stable or decreasing dose of corticosteroids for at least 1 week.
• Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• Participants with defined laboratory values at screening.
• 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 tendon, or vessels due to injury, disease, or aging in the absence of systemic mineral imbalance).
• History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/weekly) to replenish the deficiency. Vitamin D supplements are allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Squamous NSCLC; Participants with squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.	Drug: Pemigatinib; 13.5 mg tablet; Other Names: INCB 54828
Experimental: Cohort B: Non-squamous NSCLC; Participants with non-squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.	Drug: Pemigatinib; 13.5 mg tablet; Other Names: INCB 54828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) in Cohort A	ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. 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.	up to 267 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR in Cohort B	ORR was defined as the percentage of participants who achieved a CR or PR based on RECIST v1.1. Response was determined by an ICR review. 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.	up to 80 days
Progression-free Survival (PFS) in Cohort A	PFS was defined as the time from the first dose of study treatment until progressive disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. PD was defined as the progression of a target or non-target lesion or presence of a new lesion.	up to 267 days
Duration of Response (DOR) in Cohort A	DOR was defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) 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.	up to 182 days
Overall Survival (OS) in Cohort A	OS was defined as the time from the first dose of study treatment to death of any cause.	up to 267 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib.	up to 302 days
Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The investigator assessed the relationship between study drug and each occurrence of each AE/serious adverse event.	up to 302 days

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Luisa Veronese, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: relapsed or refractory; FGFR1-3 fusions; FGFR1-3 rearrangements; squamous NSCLC; fibroblast growth factor receptor (FGFR); Advanced Non-Small Cell Lung Cancer (NSCLC); FGFR1-3 mutations; nonsquamous NSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: INCB 54828-210; 2021-004934-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No