Clinical trial NCT05253807: 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Objective Response Rate (ORR) in Cohort A
timeFrame: up to 267 days
Secondary outcomes:
measure: ORR in Cohort B
timeFrame: up to 80 days
measure: Progression-free Survival (PFS) in Cohort A
timeFrame: up to 267 days
measure: Duration of Response (DOR) in Cohort A
timeFrame: up to 182 days
measure: Overall Survival (OS) in Cohort A
timeFrame: up to 267 days
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 302 days
measure: Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: up to 302 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Healthcare System
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Easton
country: United States
facility: Spoknwrd Clinical Trials Inc.
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Marseille Cedex 5
country: France
facility: Hï¿½PITAL NORD - CHU MARSEILLE
city: Toulouse
country: France
facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka Gmbh
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Lki Lungenfachklinik Immenhausen
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
city: Orbassano
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena Irccs
city: Rozzano
country: Italy
facility: Irccs Istituto Clinico Humanitas
city: A Coru?a
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Girona
country: Spain
facility: Ico Girona Hospital Universitari de Girona Dr Josep Trueta
city: Jaen
country: Spain
facility: Hospital Universitario Ciudad de Jaen
city: L'hospitalet de Llobregat
country: Spain
facility: Ico Institut Catala D Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Hm Sanchinarro
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Incyte Corporation
name: Luisa Veronese, MD
role: STUDY_DIRECTOR
References: