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

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253807
• Other study ID #: INCB 54828-210
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: November 2023
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Pemigatinib
13.5 mg tablet

Locations

Country	Name	City	State
France	H�PITAL NORD - CHU MARSEILLE	Marseille Cedex 5
France	Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol	Toulouse
Germany	Zentralklinik Bad Berka Gmbh	Bad Berka
Germany	Lungenklinik Hemer	Hemer
Germany	Lki Lungenfachklinik Immenhausen	Immenhausen
Germany	University Hospital Mannheim	Mannheim
Italy	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
Spain	Complejo Hospitalario Universitario A Coruna	A Coru?a
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General Universitario Vall D Hebron	Barcelona
Spain	Ico Girona Hospital Universitari de Girona Dr Josep Trueta	Girona
Spain	Hospital Universitario Ciudad de Jaen	Jaen
Spain	Ico Institut Catala D Oncologia	L'hospitalet de Llobregat
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario Hm Sanchinarro	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
United States	Spoknwrd Clinical Trials Inc.	Easton	Pennsylvania
United States	Florida Cancer Specialists & Research Institute	Fort Myers	Florida
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	Miami Cancer Institute	Miami	Florida
United States	Tennessee Oncology	Nashville	Tennessee
United States	Memorial Healthcare System	Pembroke Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 9 months
Secondary	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.	Up to approximately 9 months
Secondary	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.	Up to approximately 9 months
Secondary	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.	Up to approximately 9 months
Secondary	Cohort A: Overall Survival (OS)	Defined as the time from the first dose of study drug to death of any cause.	Up to approximately 9 months
Secondary	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.	Up to approximately 9 months