Your session is about to expire
← Back to Search
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
Pivotal Trial
No Placebo-Only Group
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 belowSelect...
I have not been treated with crizotinib or any ALK inhibitor.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I do not have any serious ongoing illnesses that would stop me from following the study's requirements.
Select...
I am a woman who can have children and have had a recent pregnancy test.
Select...
I don't have serious heart rhythm problems or uncontrolled atrial fibrillation.
Select...
I am not taking any strong medications or supplements that affect liver enzymes.
Select...
I have not had chemotherapy or radiation before lung cancer surgery.
Select...
I finished my previous cancer treatments at least 2 weeks ago and have recovered.
Select...
My lung cancer was surgically removed with clear margins and was stage IB (>= 4 cm), II, or IIIA.
Select...
I am not pregnant or breastfeeding.
Select...
My surgery was within the required time frame based on my treatment type.
Select...
I do not have interstitial lung disease or fibrosis.
Select...
I have not had chemotherapy or radiation before lung cancer surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
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 • NCT0163900166%
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
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%
Taste disorder
6%
Bradycardia
6%
Pneumonia
6%
Blood creatine phosphokinase MB increased
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%
Dysphagia
2%
Interstitial lung disease
2%
Death
2%
Pleural effusion
2%
Pneumothorax
1%
Subcutaneous emphysema
1%
Hepatic function abnormal
1%
Abdominal discomfort
1%
Intestinal obstruction
1%
Pancreatitis
1%
Pancreatitis acute
1%
Anaphylactic shock
1%
Impaired healing
1%
Phlebitis
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
121 Previous Clinical Trials
180,029 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,925 Total Patients Enrolled
David GerberPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
447 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT blood levels are not more than 2.5 times the upper limit of normal.Your ANC is at least 1500/mm^3.My cancer has a specific genetic change (ALK fusion) confirmed by a special test.I have not been treated with crizotinib or any ALK inhibitor.I am fully active or restricted in physically strenuous activity but can do light work.I am on low dose methotrexate or other cytotoxic agents for a non-cancer condition and can continue it during the study.I do not have any serious ongoing illnesses that would stop me from following the study's requirements.I don't have serious heart rhythm problems or uncontrolled atrial fibrillation.I finished my previous cancer treatments at least 2 weeks ago and have recovered.I am a woman who can have children and have had a recent pregnancy test.I am not taking any strong medications or supplements that affect liver enzymes.It has been at least 4 weeks since my surgery.I have not had chemotherapy or radiation before lung cancer surgery.I have recovered from previous cancer treatments, except for hair loss.I haven't had cancer that spread or needed whole-body treatment in the last 5 years, except for some skin cancers or cancers caught very early.I've had a chest CT scan within the last 6 months showing no signs of disease spread.My lung cancer was surgically removed with clear margins and was stage IB (>= 4 cm), II, or IIIA.I am not pregnant or breastfeeding.My surgery was within the required time frame based on my treatment type.Your hemoglobin level is at least 8.0 grams per deciliter.I do not have interstitial lung disease or fibrosis.Your blood creatinine level is not more than twice the upper limit of normal.I have not had chemotherapy or radiation before lung cancer surgery.I have fully recovered from my recent surgery.Your bilirubin levels in the blood should be no higher than 1.5 times the upper limit of normal.You have a platelet count of at least 30,000 per cubic millimeter of blood.I am on low dose methotrexate or other non-cancer drugs and can continue them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (crizotinib)
- Group 2: Arm B (observation)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.