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Crizotinib for Non-Small Cell Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT01639001Trial Design
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- 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.
- Group 1: Arm A (crizotinib)
- Group 2: Arm B (observation)
- 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.
- 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
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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