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Tyrosine Kinase Inhibitor

Crizotinib for Lung Cancer

Phase 2

Recruiting

Led By Natasha Leighl, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Must not have

Adverse events attributed to prior anti-cancer therapy > Grade 1 if clinically relevant

Receiving medications or substances known to be strong inhibitors or inducers of CYP3A4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of crizotinib in treating ROS1- or MET-mutated non-small cell lung cancer.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer that has spread and have specific gene changes (ROS1 or MET). They must be able to take oral meds, not have serious GI issues affecting drug absorption, use birth control, and have a life expectancy over 12 weeks. Can't join if they've had certain recent treatments or conditions like untreated brain metastases or heart rhythm problems.

What is being tested?

The study tests Crizotinib's effectiveness on lung cancer with ROS1 rearrangement or MET mutation/amplification. It's a phase 2 trial where participants receive Crizotinib to see how well it works against these genetic variations of the disease.

What are the potential side effects?

Crizotinib may cause vision disorders, nausea, diarrhea, liver enzyme elevations, swelling in legs/feet/hands/face (edema), constipation, vomiting, fatigue and decreased appetite among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My lung cancer is advanced, not squamous, and has specific genetic changes.

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I can take pills and don’t have major stomach or bowel issues affecting drug absorption.

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I can safely receive Crizotinib treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no significant side effects from previous cancer treatments.

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I am taking medication that strongly affects liver enzyme CYP3A4.

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I have brain metastases that haven't been treated and are causing symptoms.

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I have a long QT syndrome or my heart's electrical recovery time is 500 msec or longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Time-to-treatment Failure

EQ5D-5L Questionnaire Score

Edmonton Symptom Assessment Scale (ESAS) Score

+3 more

Side effects data

From 2020 Phase 3 trial • 207 Patients • NCT01639001

66%

Alanine aminotransferase increased

61%

Diarrhoea

60%

Aspartate aminotransferase increased

59%

Vomiting

54%

Nausea

41%

White blood cell count decreased

40%

Visual impairment

38%

Neutrophil count decreased

36%

Constipation

32%

Cough

28%

Headache

27%

Dizziness

26%

Oedema peripheral

26%

Decreased appetite

25%

Blood albumin decreased

21%

Pain in extremity

21%

Nasopharyngitis

20%

Neutropenia

19%

Anaemia

18%

Pyrexia

18%

Hypoalbuminaemia

17%

Upper respiratory tract infection

15%

Chest pain

15%

Dyspnoea

14%

Disease progression

14%

Blood lactate dehydrogenase increased

13%

Blood creatine phosphokinase increased

13%

Sinus bradycardia

13%

Vision blurred

13%

Gamma-glutamyltransferase increased

13%

Back pain

13%

Insomnia

13%

Protein total decreased

13%

Hypocalcaemia

12%

Rash

12%

Leukopenia

12%

Hypokalaemia

11%

Abdominal distension

10%

Abdominal pain

10%

Blood alkaline phosphatase increased

10%

Pain

10%

Alopecia

Chest discomfort

Blood creatinine increased

Fatigue

Oedema

Hypoaesthesia

Asthenia

Lymphocyte count decreased

Arthralgia

Abdominal pain upper

Platelet count decreased

Hypertension

Haemoptysis

Face oedema

Photopsia

Toothache

Haemoglobin decreased

Paraesthesia

Muscular weakness

Taste disorder

Bradycardia

Pneumonia

Blood creatine phosphokinase MB increased

Hyponatraemia

Hypoproteinaemia

Musculoskeletal pain

Red blood cell count decreased

Productive cough

Blood bilirubin increased

Pruritus

Thrombocytopenia

Pulmonary embolism

Dysphagia

Interstitial lung disease

Death

Pleural effusion

Pneumothorax

Subcutaneous emphysema

Hepatic function abnormal

Abdominal discomfort

Intestinal obstruction

Pancreatitis

Pancreatitis acute

Anaphylactic shock

Impaired healing

Phlebitis

Drug-induced liver injury

Gastrointestinal viral infection

Lower respiratory tract infection

Goitre

Ocular hypertension

Post procedural infection

Deep vein thrombosis

Cellulitis

Hyperuricaemia

Colon adenoma

Adenomyosis

Circulatory collapse

Fracture

Altered state of consciousness

100%

80%

60%

40%

20%

Study treatment Arm

Crizotinib

Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ROS1 RearrangementExperimental Treatment1 Intervention

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement will be assigned to this arm.

Group II: MET-amplificationExperimental Treatment1 Intervention

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-amplification will be assigned to this arm.

Group III: MET-activating Mutation (exon 14)Experimental Treatment1 Intervention

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-activating mutation (exon 14) will be assigned to this arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Crizotinib

2014

Completed Phase 3

~2960

0 / 9Eligibility criteria met