search
Back to results

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)

Primary Purpose

Non-Small Cell Lung Cancer (NSCLC)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer (NSCLC) focused on measuring Advanced Non-Small Cell Lung Cancer (NSCLC), fibroblast growth factor receptor (FGFR), FGFR1-3 mutations, FGFR1-3 fusions, FGFR1-3 rearrangements, squamous NSCLC, nonsquamous NSCLC, relapsed or refractory

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Valkyrie Clinical Trials
  • Florida Cancer Specialists & Research Institute
  • Miami Cancer Institute
  • Memorial Healthcare System
  • University of Kentucky Hospital
  • Spoknwrd Clinical Trials Inc.
  • Tennessee Oncology
  • H�PITAL NORD - CHU MARSEILLE
  • Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
  • Zentralklinik Bad Berka Gmbh
  • Lungenklinik Hemer
  • Lki Lungenfachklinik Immenhausen
  • University Hospital Mannheim
  • Irccs Centro Di Riferimento Oncologico
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
  • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
  • Azienda Ospedaliero Universitaria Pisana
  • Istituto Nazionale Tumori Regina Elena Irccs
  • Irccs Istituto Clinico Humanitas
  • Complejo Hospitalario Universitario A Coruna
  • Hospital General Universitario Vall D Hebron
  • Hospital Clinic de Barcelona
  • Hospital de La Santa Creu I Sant Pau
  • Ico Girona Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitario Ciudad de Jaen
  • Ico Institut Catala D Oncologia
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario de La Paz
  • Hospital Universitario Hm Sanchinarro
  • Hospital Regional Universitario de Malaga
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A: Squamous NSCLC

Cohort B: Non-squamous NSCLC

Arm Description

Participants with squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.

Participants with non-squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.

Outcomes

Primary Outcome Measures

Cohort A: Overall Response Rate (ORR)
Defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1. Response will be determined by an Independent Central Radiology (ICR) review.

Secondary Outcome Measures

Cohort B: ORR
Defined as the proportion of participants who achieve a CR or PR based on RECIST v1.1. Response will be determined by an ICR review.
Cohort A: Progression-Free Survivol (PFS)
Defined as the time from the first dose of study drug until Progressive Disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever is first.
Cohort A: Duration of Response (DOR)
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 is first.
Cohort A: Overall Survival (OS)
Defined as the time from the first dose of study drug to death of any cause.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Full Information

First Posted
February 14, 2022
Last Updated
June 1, 2023
Sponsor
Incyte Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05253807
Brief Title
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
Acronym
FIGHT-210
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC)
Keywords
Advanced Non-Small Cell Lung Cancer (NSCLC), fibroblast growth factor receptor (FGFR), FGFR1-3 mutations, FGFR1-3 fusions, FGFR1-3 rearrangements, squamous NSCLC, nonsquamous NSCLC, relapsed or refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants enrolled in this study will be assigned to 1 of 2 cohorts: Cohort A (squamous NSCLC) will enroll approximately 100 participants, and Cohort B (nonsquamous NSCLC) will enroll approximately 25 participants.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Squamous NSCLC
Arm Type
Experimental
Arm Description
Participants with squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.
Arm Title
Cohort B: Non-squamous NSCLC
Arm Type
Experimental
Arm Description
Participants with non-squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB 54828
Intervention Description
13.5 mg tablet
Primary Outcome Measure Information:
Title
Cohort A: Overall Response Rate (ORR)
Description
Defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1. Response will be determined by an Independent Central Radiology (ICR) review.
Time Frame
Up to approximately 9 months
Secondary Outcome Measure Information:
Title
Cohort B: ORR
Description
Defined as the proportion of participants who achieve a CR or PR based on RECIST v1.1. Response will be determined by an ICR review.
Time Frame
Up to approximately 9 months
Title
Cohort A: Progression-Free Survivol (PFS)
Description
Defined as the time from the first dose of study drug until Progressive Disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever is first.
Time Frame
Up to approximately 9 months
Title
Cohort A: Duration of Response (DOR)
Description
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 is first.
Time Frame
Up to approximately 9 months
Title
Cohort A: Overall Survival (OS)
Description
Defined as the time from the first dose of study drug to death of any cause.
Time Frame
Up to approximately 9 months
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to approximately 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa Veronese, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Memorial Healthcare System
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Spoknwrd Clinical Trials Inc.
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
H�PITAL NORD - CHU MARSEILLE
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Zentralklinik Bad Berka Gmbh
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Lki Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Irccs Centro Di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena Irccs
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coru?a
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Ciudad de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
L'hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

We'll reach out to this number within 24 hrs