Clinical Trials for ALK-positive Cancers - Are They for Me?
Should I enroll in a clinical trial for ALK-positive cancer?
The decision to enroll in a clinical trial requires a real understanding of what is being studied and how you will participate in the study. It is important to remember that clinical trials have been instrumental in developing all treatments for ALK-positive cancers. Many of our longest survivors have participated in clinical trials of treatments that are now the standard of care.
Why should ALK-positive patients in particular enroll in clinical trials?
Since ALK-positive cancer is a rare disease, it takes a long time to recruit enough patients for a clinical trial. The longer it takes to complete a clinical trial, the longer it takes to find better treatments for the illness. If you join a clinical trial, you help speed recruitment, which then speeds up results. Everyone with ALK-positive cancer will benefit from your participation.
What are the types of clinical trials?
There are several types of clinical trials. Interventional clinical trials are where you are given a new treatment either alone or in addition to a standard treatment. The new treatment could be a drug or other treatment that is not FDA approved yet, or it could be an approved treatment being used in a new way.
The other types of trials are prevention, screening, monitoring, diagnostic, and supportive care. These trials do not test a new treatment; instead, they gather information about other aspects of the diagnostic and treatment process.
What are the “phases” of Clinical Trials?
Phase 1 Trial: This is a first in human study. A treatment has been tested in the lab and/or in animals, and it is now ready for use in humans. Phase 1 trials determine safety and correct dosing of a treatment along with effectiveness. Phase 1 trial participants have often had progression on other treatments.
Phase 2 Trial: This is a study of a treatment that has been determined to be safe in phase 1 trials. These trials enroll more participants than phase 1 trials with more standardized dosing.
Phase 3 Trial: This is a larger study of a treatment that has been shown to be effective in phase 2 trials. In these trials there is a comparison to the current standard treatment. Those in the trial are randomly divided into 2 groups. One group receives the new investigational treatment while the other receives the current standard treatment.
Am I eligible to enroll in a clinical trial?
Trial eligibility is different for every clinical study. There are many studies that are exclusively for ALK-positive lung cancer patients and some that are for lung cancer in general but include ALK. To enter a trial, one must usually be physically strong enough to tolerate the potential side effects of the new treatment.
Each clinical trial may have several locations, sometimes even in small cancer clinics.
How can I find out about clinical trials?
Your doctor may refer you to a clinical trial, and this is ideal. But do not rely solely on your medical team to find the right clinical trial for you. There are many trials available, and it would be difficult for any oncologist to be aware of all current clinical trials. You are most invested in your care, and you can find a clinical trial that meets your needs.
There are also websites that can help you find a study, including lungcanceralliance.org, lungevity.org, and www.antidote.me.
In addition, ALK Positive has a spreadsheet that lists clinical trials for ALK, with locations of trials listed. You can find it at Clinical Trials Recruiting for ALK Cancers
What are the advantages of enrolling in a clinical trial?
· You may receive cutting edge treatment that could help you live longer.
· The study treatment will be free of cost to you and your insurance company.
· You will receive careful monitoring from an interested treatment team.
· Your doctor will likely have more experience and expertise in ALK-positive cancer.
· Your response to the new treatment will be recorded and will help determine treatment for ALK-positive patients in the future.
What are the disadvantages of enrolling in a clinical trial?
· You may have to travel some distance to the clinical trial location.
· The study may require more frequent appointments and tests, which may be inconvenient and may result in more co-pays and/or other medical expenses.
· The new treatment may not be more effective than the standard care.
· There may be unexpected treatment results, side effects, or toxicity.
When is the best time to enroll in a clinical trial?
Clinical trials are recruiting for all stages of disease, so you can enroll in clinical trials at many points in your treatment. These are the best times to enroll: before any treatment at all, when you are not tolerating your current treatment, when you have had progression on your current treatment, or when you have exhausted all standard treatments.
Frequently Asked Questions about clinical trials:
Will I get a placebo? Probably not. In the few trials with placebos, the placebo is added to standard treatment. If you are in the placebo group, it will be added to an effective treatment for your illness.
Can I quit the clinical trial at any time and choose to get standard treatment instead? Yes. You will sign an informed consent form that explains your rights.
Can I contact the sponsor of a clinical trial on my own? Yes. You can contact the study sponsors directly to find out more about the trial or your oncologist can contact them on your behalf. Their contact information is in the listing for the trial on the website ClinicalTrials.gov.
Will I get paid for being in an interventional trial? No. Treatment studies do not pay patients. But other types of studies can offer reimbursement for filling out questionnaires or other tasks.
What are the main reasons I would not be eligible for an ALK clinical trial? The main reasons for exclusion are these: leptomeningeal disease, interstitial lung disease (pneumonitis), another active cancer, or another serious health problem that would put you at risk or confuse the results of the trial.
Almost anyone with ALK-positive cancer can be a good fit for a clinical trial. A clinical trial can give you access to cutting edge treatment, and the study treatment will be provided free of cost. Clinical trials are available at all stages of treatment. Although your oncologist can refer you to a clinical trial, you may need to do some research to find a trial on your own. Participating in a clinical trial is a valuable way to enhance your treatment and help find a cure for ALK-positive cancers.
Click here for the ALK Positive Clinical Trials Spreadsheet: Clinical Trials Currently Recruiting for ALK-positive Cancers
As of May 2023, there are at least 50 clinical trials that are recruiting specifically for people with ALK-positive lung cancer. Many of these trials have multiple sites worldwide. Since ALK-positive cancer is a rare disease, it is difficult for any single oncologist to be aware of all the trials available. You can advocate for yourself and find a clinical trial that may be a good fit for you at any juncture in treatment.
*The ALK Positive Clinical Trials Spreadsheet was developed by the ALK Positive Medical Committee. The database is updated monthly. Disclaimer: these trials have been consolidated by volunteers and should not be considered exhaustive. Listing of these trials is not an endorsement, and ALK Positive does not recommend one trial over another. Please talk with your doctor about these or any trials you are interested in.
Author: Ellee Urban