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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
55%
White blood cell count decreased
50%
Nausea
49%
Anaemia
46%
Vomiting
45%
Alanine aminotransferase increased
37%
Neutropenia
35%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
Decreased appetite
27%
Constipation
27%
Platelet count decreased
24%
Cough
21%
Haemoglobin decreased
20%
Leukopenia
17%
Chest pain
17%
Fatigue
16%
Blood albumin decreased
16%
Hyponatraemia
15%
Pyrexia
13%
Back pain
11%
Dizziness
11%
Dyspnoea
11%
Alopecia
10%
Thrombocytopenia
10%
Asthenia
9%
Diarrhoea
9%
Headache
9%
Insomnia
9%
Red blood cell count decreased
8%
Phlebitis
8%
Visual impairment
8%
Upper respiratory tract infection
8%
Nasopharyngitis
8%
Hypoalbuminaemia
8%
Haemoptysis
8%
Pruritus
7%
Rash
7%
Hypokalaemia
6%
Lymphocyte count decreased
6%
Blood bilirubin increased
6%
Pain in extremity
6%
Abdominal distension
6%
Pain
6%
Productive cough
5%
Oedema peripheral
5%
Musculoskeletal pain
4%
Arthralgia
4%
Vision blurred
4%
Chest discomfort
4%
Blood alkaline phosphatase increased
4%
Gamma-glutamyltransferase increased
4%
Paraesthesia
4%
Hypocalcaemia
3%
Abdominal pain
3%
Protein total decreased
2%
Abdominal pain upper
2%
Hypoaesthesia
1%
Pleural effusion
1%
Disease progression
1%
Death
1%
Blood creatinine increased
1%
Pneumonia
1%
Oedema
1%
Blood lactate dehydrogenase increased
1%
Hypoproteinaemia
1%
Hypertension
1%
Pericardial effusion
1%
Syncope
1%
Transaminases increased
1%
Cerebral infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy
Crizotinib

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
~2370

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,472 Total Patients Enrolled
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,634,153 Total Patients Enrolled
Natasha Leighl, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Crizotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04084717 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: MET-amplification, ROS1 Rearrangement, MET-activating Mutation (exon 14)
Non-Small Cell Lung Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT04084717 — Phase 2
Crizotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04084717 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research been conducted with Crizotinib in the past?

"Currently, 32 Crizotinib trials are ongoing. Of these, 6 have entered the third phase of clinical research and they originate from a single site in Pahrump, Nevada. Globally, there are 6887 locations running studies related to this drug therapy."

Answered by AI

What adverse effects should be expected with Crizotinib treatments?

"The safety of Crizotinib has been judged to be a 2 on the 1-3 scale, owing to its status as a Phase 2 trial. This implies that while there is data backing up the medication's safety, efficacy cannot yet be confirmed."

Answered by AI

What is the maximum number of participants accepted for this research endeavor?

"Affirmative. The clinicaltrials.gov website states that this medical research is currently enlisting participants, with the first post being published on December 3rd 2019 and the most recent update occurring November 26th 2021. This trial requires 50 individuals to be recruited from a single site."

Answered by AI

Is there an opportunity to join this experiment at the current time?

"According to official records from clinicaltrials.gov, this medical trial is presently recruiting participants. The study was first posted on December 3rd 2019 and its information was most recently updated on November 26th 2021."

Answered by AI

Is this an unprecedented research endeavor?

"Since 2011, Crizotinib has been extensively studied. Pfizer was the initial sponsor of a clinical trial in 2011 involving 44 patients; it eventually led to Phase 1 drug approval. Currently, 32 trials are active worldwide across 1204 cities and 36 nations."

Answered by AI
~5 spots leftby Dec 2024