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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer (NSCLC)

In brief

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

Key facts

Study ID: NCT05253807
Run by: Incyte Corporation
People needed: 8
Starts: 2022-04-29
Expected to finish: 2023-08-16
Last updated by the study team: 2025-08-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
Hï¿½PITAL 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

Full record on ClinicalTrials.gov

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