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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
Study 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.Check my eligibility
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.See study design
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.
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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 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
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 • NCT0163900155%
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
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
~2370
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,754 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,686 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other efficacy studies have been done on Crizotinib?
"Crizotinib was first studied in 2007 at Surgical Intensive Care Unit Regional Hospital Jessa. As of now, there have been a total of 640 completed clinical trials. Out of these, 69 are active and ongoing, with a majority of these studies taking place in Canandaigua, New york."
Answered by AI
Could you please elucidate the risks associated with Crizotinib?
"Crizotinib has been deemed safe by our team at Power. This is due to the fact that it is a Phase 3 trial, which means that there is some data to support its efficacy and multiple rounds of data that support its safety."
Answered by AI
How many individuals are being included in this scientific research project?
"168 suitable patients are needed to fill the spots for this trial. Those who meet the requirements and live near one of the participating locations, such as Las Vegas Urology - Smoke Ranch in Canandaigua, New york or OptumCare Cancer Care at MountainView in Hendersonville, North carolina, are encouraged to apply."
Answered by AI
Are people needed for this clinical trial right now?
"That is correct. The online information from clinicaltrials.gov indicates that this research is still looking for 168 individuals from 100 different locations. The trial was originally posted on August 18th, 2014 with the most recent update happening on July 26th, 2022."
Answered by AI
Does this clinical trial use any innovative or cutting-edge methods?
"As of now, there are 69 open clinical trials involving Crizotinib in 38 countries and 1221 cities. The very first trial was sponsored by Baxter Healthcare Corporation in 2007. That initial study had 4640 participants and successfully completed Phase 4 drug approval. Since that initial trial, there have been 640 more."
Answered by AI
What are the FDA-approved indications for crizotinib?
"Crizotinib is the standard course of treatment for amino acid supplementation therapy. However, this medication can also be used to help patients with renal dysfunction, amino acid supplementation, and kidney failure."
Answered by AI
Are there different hospitals in state conducting this research?
"Currently, patients are being enrolled at Las Vegas Urology - Smoke Ranch in Canandaigua, New york, OptumCare Cancer Care at MountainView in Hendersonville, North carolina, and Sands Cancer Center in Belpre, Ohio. 100 other recruitment sites are also operational."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Maryland
How old are they?
65+
What site did they apply to?
Loma Linda University Medical Center
Boulder Community Hospital
Rocky Mountain Cancer Centers-Thornton
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
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