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Tyrosine Kinase Inhibitor

Crizotinib for Non-Small Cell Lung Cancer

Phase 3
Recruiting
Led By David Gerber
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior treatment with crizotinib or another ALK inhibitor
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial studies crizotinib for patients with stage IB-IIIA NSCLC who have had surgery and have an ALK fusion mutation. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working.

Who is the study for?
This trial is for adults who've had surgery to remove stage IB-IIIA non-small cell lung cancer and have an ALK gene mutation. They should not be pregnant or breastfeeding, must not have other serious illnesses, and cannot have had certain cancers within the last 5 years. Participants need a good performance status (able to carry out daily activities) and can't be on drugs that strongly affect liver enzymes.
What is being tested?
The study is testing if crizotinib, which blocks a protein called ALK involved in tumor growth, is effective after surgery in patients with specific genetic changes in their lung cancer. It's compared against regular follow-up without this drug. Patients are randomly assigned to either receive crizotinib or undergo clinical observation.
What are the potential side effects?
Crizotinib may cause side effects like vision problems, nausea, diarrhea, constipation, vomiting, swelling of hands/feet/ankles (edema), dizziness upon standing up (orthostatic hypotension), liver problems indicated by blood tests changes, heart issues including slow heartbeat (bradycardia), and potential kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not been treated with crizotinib or any ALK inhibitor.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have any serious ongoing illnesses that would stop me from following the study's requirements.
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I am a woman who can have children and have had a recent pregnancy test.
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I don't have serious heart rhythm problems or uncontrolled atrial fibrillation.
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I am not taking any strong medications or supplements that affect liver enzymes.
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I have not had chemotherapy or radiation before lung cancer surgery.
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I finished my previous cancer treatments at least 2 weeks ago and have recovered.
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My lung cancer was surgically removed with clear margins and was stage IB (>= 4 cm), II, or IIIA.
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I am not pregnant or breastfeeding.
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My surgery was within the required time frame based on my treatment type.
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I do not have interstitial lung disease or fibrosis.
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I have not had chemotherapy or radiation before lung cancer surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Overall survival (OS)
Secondary study objectives
Disease free survival (DFS)
Toxicity rates, determined using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

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%
Leukopenia
12%
Rash
12%
Hypokalaemia
11%
Abdominal distension
10%
Abdominal pain
10%
Blood alkaline phosphatase increased
10%
Pain
10%
Alopecia
9%
Chest discomfort
9%
Blood creatinine increased
9%
Fatigue
9%
Oedema
9%
Hypoaesthesia
8%
Asthenia
8%
Lymphocyte count decreased
8%
Arthralgia
8%
Abdominal pain upper
8%
Platelet count decreased
8%
Hypertension
8%
Haemoptysis
7%
Face oedema
7%
Photopsia
7%
Toothache
7%
Haemoglobin decreased
7%
Paraesthesia
7%
Muscular weakness
6%
Pneumonia
6%
Blood creatine phosphokinase MB increased
6%
Bradycardia
6%
Taste disorder
6%
Hyponatraemia
6%
Hypoproteinaemia
6%
Musculoskeletal pain
6%
Red blood cell count decreased
6%
Productive cough
5%
Blood bilirubin increased
5%
Pruritus
4%
Thrombocytopenia
3%
Pulmonary embolism
2%
Interstitial lung disease
2%
Death
2%
Pleural effusion
2%
Dysphagia
2%
Pneumothorax
1%
Subcutaneous emphysema
1%
Phlebitis
1%
Anaphylactic shock
1%
Pancreatitis acute
1%
Abdominal discomfort
1%
Hepatic function abnormal
1%
Intestinal obstruction
1%
Pancreatitis
1%
Impaired healing
1%
Drug-induced liver injury
1%
Gastrointestinal viral infection
1%
Lower respiratory tract infection
1%
Goitre
1%
Ocular hypertension
1%
Post procedural infection
1%
Deep vein thrombosis
1%
Cellulitis
1%
Hyperuricaemia
1%
Colon adenoma
1%
Adenomyosis
1%
Circulatory collapse
1%
Fracture
1%
Altered state of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Crizotinib
Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (crizotinib)Experimental Treatment2 Interventions
Patients receive crizotinib PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (observation)Active Control2 Interventions
Patients undergo observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizotinib
2014
Completed Phase 3
~2960

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
178,879 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,832 Total Patients Enrolled
David GerberPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
447 Total Patients Enrolled

Media Library

Crizotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02201992 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A (crizotinib), Arm B (observation)
Non-Small Cell Lung Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT02201992 — Phase 3
Crizotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02201992 — Phase 3
~92 spots leftby May 2036
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