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

NCT ID: NCT05253807

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2023-08-16

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

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pemigatinib

Intervention Type: DRUG

13.5 mg tablet

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.

Group Type: EXPERIMENTAL

Pemigatinib

Intervention Type: DRUG

13.5 mg tablet

Interventions

Pemigatinib

13.5 mg tablet

Intervention Type: DRUG

Other Intervention Names

INCB 54828

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luisa Veronese, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Valkyrie Clinical Trials

Los Angeles, California, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Memorial Healthcare System

Pembroke Pines, Florida, United States

University of Kentucky Hospital

Lexington, Kentucky, United States

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

H�PITAL NORD - CHU MARSEILLE

Marseille, , France

Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

Toulouse, , France

Zentralklinik Bad Berka Gmbh

Bad Berka, , Germany

Lungenklinik Hemer

Hemer, , Germany

Lki Lungenfachklinik Immenhausen

Immenhausen, , Germany

University Hospital Mannheim

Mannheim, , Germany

Irccs Centro Di Riferimento Oncologico

Aviano, , Italy

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, , Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

Meldola, , Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

Orbassano, , Italy

Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

Perugia, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Istituto Nazionale Tumori Regina Elena Irccs

Roma, , Italy

Irccs Istituto Clinico Humanitas

Rozzano, , Italy

Complejo Hospitalario Universitario A Coruna

A Coru?a, , Spain

Hospital General Universitario Vall D Hebron

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

Ico Girona Hospital Universitari de Girona Dr Josep Trueta

Girona, , Spain

Hospital Universitario Ciudad de Jaen

Jaén, , Spain

Ico Institut Catala D Oncologia

L'Hospitalet de Llobregat, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de La Paz

Madrid, , Spain

Hospital Universitario Hm Sanchinarro

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

United States; France; Germany; Italy; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-004934-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 54828-210

Identifier Type: -

Identifier Source: org_study_id