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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 302 days for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 147 Patients • NCT02924376

59%

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

Dyspnoea

Vitamin D deficiency

Onycholysis

Cough

Abdominal distension

Hyperbilirubinaemia

Hypertension

Hypokalaemia

Paronychia

Onychoclasis

Blood creatinine increased

Aspartate aminotransferase increased

Growth of eyelashes

Fall

Punctate keratitis

Erythema

Nasal congestion

Platelet count decreased

Conjunctivitis

Lacrimation increased

Nail disorder

Nasopharyngitis

Neuropathy peripheral

Skin exfoliation

Taste disorder

Upper respiratory tract infection

Cataract

Eye pain

Chills

Blood bilirubin increased

Depression

Hyponatraemia

Ocular hyperaemia

Influenza like illness

Dysphagia

Vitreous floaters

Cystitis

Cholangitis

Flank pain

Hypotension

Acute kidney injury

Muscular weakness

Neck pain

Oral candidiasis

Hyperuricaemia

Pain

Weight increased

Ascites

Skin fissures

Lymphocyte count decreased

Keratitis

Activated partial thromboplastin time prolonged

Breast pain

Dyspnoea exertional

Tinnitus

Blood parathyroid hormone decreased

Pollakiuria

Bronchitis

Cholangitis infective

Non-cardiac chest pain

Decubitus ulcer

Sepsis

Blood 1,25-dihydroxycholecalciferol increased

Electrocardiogram QT prolonged

Hypoalbuminaemia

Failure to thrive

Bacteraemia

Hypocalcaemia

Palpitations

Pharyngitis

Rash maculo-papular

Tachycardia

Trichomegaly

Dysuria

Hyperglycaemia

Dysphonia

Device occlusion

Small intestinal obstruction

Blood 1,25-dihydroxycholecalciferol decreased

Chronic kidney disease

Biliary obstruction

Pleural effusion

Pneumonia

Hypercholesterolaemia

Prostate cancer

Skin infection

Retinal detachment

Septic shock

Thrombosis

Biliary tract infection

Complication associated with device

Enterobacter bacteraemia

Intestinal obstruction

Hyperkalaemia

Jaundice

Kidney infection

Oesophageal varices haemorrhage

Micturition urgency

Seizure

Pseudomonal bacteraemia

Varices oesophageal

Oral herpes

Clostridium difficile infection

Device leakage

Gynaecomastia

Somnolence

Catheter site infection

Gastrointestinal haemorrhage

Haematemesis

Hydronephrosis

Optic ischaemic neuropathy

Pneumonitis

Transaminases increased

C-reactive protein increased

Cancer pain

Candida infection

Confusional state

Herpes zoster

Musculoskeletal pain

Psoriasis

Blood chloride decreased

Cerebrovascular accident

Malignant biliary obstruction

Melaena

Paraplegia

Pneumonia aspiration

Pneumonia pneumococcal

Syncope

Haemorrhoids

Sinus pain

Urinary tract pain

100%

80%

60%

40%

20%

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

~250

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