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Tyrosine Kinase Inhibitor
Pemigatinib for Non-Small Cell Lung Cancer (FIGHT-210 Trial)
Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 302 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Pemigatinib, a medication that targets specific genetic changes in lung cancer cells. It is for patients with certain types of lung cancer who have not responded to other treatments. Pemigatinib works by blocking proteins that help cancer cells grow.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 302 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 302 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR) in Cohort A
Secondary study objectives
Duration of Response (DOR) in Cohort A
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Number of Participants With Any Treatment-related TEAE According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
+3 moreSide effects data
From 2022 Phase 2 trial • 147 Patients • NCT0292437659%
Alopecia
56%
Hyperphosphataemia
54%
Diarrhoea
46%
Fatigue
43%
Stomatitis
43%
Constipation
42%
Nausea
42%
Dysgeusia
39%
Dry mouth
35%
Dry eye
34%
Arthralgia
32%
Vomiting
31%
Decreased appetite
28%
Dry skin
26%
Hypophosphataemia
25%
Back pain
24%
Pain in extremity
21%
Palmar-plantar erythrodysaesthesia syndrome
20%
Abdominal pain
19%
Headache
19%
Urinary tract infection
19%
Weight decreased
18%
Dizziness
18%
Epistaxis
15%
Oedema peripheral
15%
Hypercalcaemia
15%
Anaemia
15%
Dehydration
14%
Myalgia
14%
Asthenia
13%
Dyspepsia
12%
Gastrooesophageal reflux disease
12%
Insomnia
12%
Nasal dryness
12%
Pruritus
12%
Onychomadesis
11%
Blood alkaline phosphatase increased
11%
Rash
11%
Nail discolouration
11%
Alanine aminotransferase increased
10%
Muscle spasms
10%
Pyrexia
10%
Abdominal pain upper
10%
Nail dystrophy
10%
Oropharyngeal pain
10%
Trichiasis
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Abdominal distension
8%
Hyperbilirubinaemia
8%
Hypertension
8%
Hypokalaemia
8%
Paronychia
8%
Onychoclasis
8%
Blood creatinine increased
8%
Aspartate aminotransferase increased
7%
Growth of eyelashes
7%
Fall
7%
Punctate keratitis
7%
Erythema
7%
Nasal congestion
7%
Platelet count decreased
6%
Conjunctivitis
6%
Lacrimation increased
6%
Nail disorder
6%
Nasopharyngitis
6%
Neuropathy peripheral
6%
Skin exfoliation
6%
Taste disorder
6%
Upper respiratory tract infection
6%
Cataract
6%
Eye pain
6%
Chills
6%
Blood bilirubin increased
6%
Depression
6%
Hyponatraemia
6%
Ocular hyperaemia
6%
Influenza like illness
5%
Dysphagia
5%
Vitreous floaters
5%
Cystitis
5%
Cholangitis
5%
Flank pain
5%
Hypotension
5%
Acute kidney injury
5%
Muscular weakness
5%
Neck pain
5%
Oral candidiasis
4%
Hyperuricaemia
4%
Pain
4%
Weight increased
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Activated partial thromboplastin time prolonged
3%
Breast pain
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Decubitus ulcer
2%
Sepsis
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Electrocardiogram QT prolonged
2%
Hypoalbuminaemia
2%
Failure to thrive
2%
Bacteraemia
2%
Hypocalcaemia
2%
Palpitations
2%
Pharyngitis
2%
Rash maculo-papular
2%
Tachycardia
2%
Trichomegaly
2%
Dysuria
2%
Hyperglycaemia
2%
Dysphonia
2%
Device occlusion
2%
Small intestinal obstruction
2%
Blood 1,25-dihydroxycholecalciferol decreased
2%
Chronic kidney disease
2%
Biliary obstruction
2%
Pleural effusion
2%
Pneumonia
2%
Hypercholesterolaemia
1%
Prostate cancer
1%
Skin infection
1%
Retinal detachment
1%
Septic shock
1%
Thrombosis
1%
Biliary tract infection
1%
Complication associated with device
1%
Enterobacter bacteraemia
1%
Intestinal obstruction
1%
Hyperkalaemia
1%
Jaundice
1%
Kidney infection
1%
Oesophageal varices haemorrhage
1%
Micturition urgency
1%
Seizure
1%
Pseudomonal bacteraemia
1%
Varices oesophageal
1%
Oral herpes
1%
Clostridium difficile infection
1%
Device leakage
1%
Gynaecomastia
1%
Somnolence
1%
Catheter site infection
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Hydronephrosis
1%
Optic ischaemic neuropathy
1%
Pneumonitis
1%
Transaminases increased
1%
C-reactive protein increased
1%
Cancer pain
1%
Candida infection
1%
Confusional state
1%
Herpes zoster
1%
Musculoskeletal pain
1%
Psoriasis
1%
Blood chloride decreased
1%
Cerebrovascular accident
1%
Malignant biliary obstruction
1%
Melaena
1%
Paraplegia
1%
Pneumonia aspiration
1%
Pneumonia pneumococcal
1%
Syncope
1%
Haemorrhoids
1%
Sinus pain
1%
Urinary tract pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: FGFR2 Rearrangements or Fusions
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Cohort C: Negative for FGF/FGFR Alterations
Other
Total
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: Non-squamous NSCLCExperimental Treatment1 Intervention
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 II: Cohort A: Squamous NSCLCExperimental Treatment1 Intervention
Participants with squamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements will receive intermittent dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
2022
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
392 Previous Clinical Trials
63,933 Total Patients Enrolled
Luisa Veronese, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You agree not to get pregnant or make someone pregnant during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Squamous NSCLC
- Group 2: Cohort B: Non-squamous NSCLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.