FIGHT-210: 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

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05253807

Collaborator

(none)

125

Enrollment

Locations

Arms

44.7

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer (NSCLC)	Drug: Pemigatinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 29, 2022

Anticipated Primary Completion Date :

Jan 19, 2026

Anticipated Study Completion Date :

Jan 19, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cohort A: Overall Response Rate (ORR) [Up to approximately 9 months]
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 [Up to approximately 9 months]
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) [Up to approximately 9 months]
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) [Up to approximately 9 months]
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) [Up to approximately 9 months]
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) [Up to approximately 9 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valkyrie Clinical Trials	Los Angeles	California	United States	90067
2	Florida Cancer Specialists & Research Institute	Fort Myers	Florida	United States	33901
3	Miami Cancer Institute	Miami	Florida	United States	33176
4	Memorial Healthcare System	Pembroke Pines	Florida	United States	33028
5	Florida Cancer Specialists	Saint Petersburg	Florida	United States	33705
6	Rush University Medical Center - Consultants in Hematology	Chicago	Illinois	United States	60612
7	University of Kentucky Hospital	Lexington	Kentucky	United States	40536-0298
8	Roswell Park Comprehensive Cancer Center	Buffalo	New York	United States	14263
9	Spoknwrd Clinical Trials Inc.	Easton	Pennsylvania	United States	18045
10	Tennessee Oncology	Nashville	Tennessee	United States	37203
11	Institut Bergonie	Bordeaux Cedex		France	33076
12	Chu Hopital de La Timone	Marseille Cedex 5		France	13385
13	Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol	Toulouse		France	31000
14	Zentralklinik Bad Berka Gmbh	Bad Berka		Germany	99437
15	University Medical Center Freiburg	Freiburg		Germany	79106
16	Mvz Martha-Maria Halle-Doelau	Halle		Germany	06120
17	Lungenklinik Hemer	Hemer		Germany	58675
18	Lki Lungenfachklinik Immenhausen	Immenhausen		Germany	34376
19	University Hospital Mannheim	Mannheim		Germany	68167
20	Irccs Centro Di Riferimento Oncologico	Aviano		Italy	33081
21	Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari	Bari		Italy	70124
22	Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori	Meldola		Italy	47014
23	Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano	Orbassano		Italy	10043
24	Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia	Perugia		Italy	06132
25	Azienda Ospedaliero Universitaria Pisana	Pisa		Italy	56124
26	Istituto Nazionale Tumori Regina Elena Irccs	Roma		Italy	00144
27	Irccs Istituto Clinico Humanitas	Rozzano		Italy	20089
28	Complejo Hospitalario Universitario A Coruna	A Coruna		Spain	15006
29	Hospital General Universitario Vall D Hebron	Barcelona		Spain	08035
30	Hospital Clinic de Barcelona	Barcelona		Spain	08036
31	Hospital de La Santa Creu I Sant Pau	Barcelona		Spain	08041
32	Ico Girona Hospital Universitari de Girona Dr Josep Trueta	Girona		Spain	17007
33	Hospital Universitario Ciudad de Jaen	Jaen		Spain	23007
34	Ico Institut Catala D Oncologia	L'hospitalet de Llobregat		Spain	08908
35	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28007
36	Hospital Universitario Ramon Y Cajal	Madrid		Spain	28034
37	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
38	Hospital Universitario de La Paz	Madrid		Spain	28046
39	Hospital Universitario Hm Sanchinarro	Madrid		Spain	28050
40	Hospital Regional Universitario de Malaga	Malaga		Spain	29010
41	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
42	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009