By Daniel A. Saez, M.Sc., Treatment and Trials Navigator, GO2 for Lung Cancer
Patients often hear the words clinical trial and don’t know what to expect or sometimes even what a clinical trial is. GO2 for Lung Cancer has put together a list of frequently asked questions surrounding clinical trials for you to have a better understanding of how clinical trials relate to your treatment journey.
What is a clinical trial?
- A clinical trial is a research study involving people. This could be observational, biobanking (storing of biological samples for use in research), or to determine the effectiveness of a new therapy (or combination of therapies).
- Clinical trials can study new therapies, new uses of already approved therapies, or new combinations of already approved therapies.
Who is in charge of a clinical trial?
- Clinical trials are run by the principal investigator (PI).
- A PI is a scientist or doctor who is an expert in the subject of the trial.
- Clinical trials at multiple sites follow the same protocol designed by the PI.
What do clinical trials want to find out?
- The information that a clinical trial is trying to find out usually depends on the phase of the trial
- Phase 1 trials want to find out best dose for a therapy. Small doses of the therapy are given to some patients with increasing doses given to other patients. Doctors track the side effects of the therapy at each dose to determine if it is safe enough to move on to phase 2.
- Phase 2 trials continue to find out the safety profile of a therapy on a larger population of patients in a more specific type of cancer. While doctors track side effects and safety of the therapy, they also closely monitor if the therapy is working for patients on the trial. If a therapy is found to work, it can move on to phase 3.
- Phase 3 trials compare new therapies (or new combinations of therapies) to the current standard of care. For therapies to make it to phase 3 they have already proven to be tolerable and effective. The goal of a phase 3 trial is to find out if the new therapy (or new combination) is better than what is currently being used.
- After a treatment is approved, a phase 4 may also be required where the treatment is studied in additional people.
Who are clinical trials for?
- Clinical trials are all types of patients across all stages of lung cancer.
- Trials can enroll patients from stage 1 to stage 4 depending on the question the trial is trying to answer.
- Trials exist for patients with either non-small lung cancer (NSCLC), small cell lung cancer, or other rare types.
- For patients with NSCLC, trials exist for those with or without driver mutations.
How do I know if I am eligible for a clinical trial?
- Every clinical trial has different criteria for the patients who can participate in them. For more information on the criteria for a specific trial, contact the trial coordinator.
- Different clinical trials look for different types of patients so the easiest way to know if you are eligible is to talk to your doctor or call the GO2 for Lung Cancer HelpLine at 1-800-298-2436 and ask to speak to a LungMATCH specialist.
Can I stay with my doctor if I join a clinical trial?
- When patients enroll in a clinical trial the treating oncologist for the trial site becomes their doctor, in many but not all trials. Some types of trials where the patient’s treating oncologist does not change include biobanking trials.
How do I find out about clinical trials?
- There are several ways for patients to learn about clinical trials:
- Talk to your doctor about trials and see if they know of any.
- Call the GO2 for Lung Cancer HelpLine at 1-800-298-2436 and ask to speak to a LungMATCH specialist for a personalized nationwide clinical trial search free of charge.
- Seek a second opinion from a new doctor and ask if they know of any clinical trials for you.
- Use online clinical trial finders such as Antidote and TrialJectory.
What are the risks of a clinical trial?
- Depending on the phase of the clinical trial, how the therapy will affect you could be largely unknown.
- Like with approved therapies, every patient is different and even if there is already a lot known about a therapy, it is impossible to know if you will react to it the exact same way that other patients will or have in the past.
What do I get out of joining a clinical trial?
- Patients on a clinical trial get access to the most current cancer care, are treated by experts in the field, are closely monitored, and the results of being on the trial could help other patients with cancer.
What about placebos (a substance with no therapeutic effect used as a control measure)?
- Clinical trials for cancer patients do not use placebos alone. In clinical trials where a control group exists who does not receive the new treatment, these patients will receive the current standard of care.
Will I know if I am getting the experimental therapy?
- Not always. Clinical trials can either be open or blinded. In blinded trials, the patient (and many times the doctor) will not know what they are receiving. In open trials, everyone knows what the patient is receiving. Consider what type of trial you want and make sure that is what you are considering.
How do I know which trial is best for me?
- Knowing which trial is most suitable for a patient depends on a few different things: what phase is the trial, has the therapy been approved in a different use already, what are the logistics of the trial.
- The best way to get answers to these are to talk to your doctor about the trials you have in mind or call the GO2 for Lung Cancer HelpLine at 1-800-298-2436 and ask to speak to a LungMATCH specialist.
Ok, I’m sold. How do I get involved in a clinical trial?
- Getting enrolled in a clinical trial is a process which starts by contacting the trial researcher yourself or having your doctor do so. This information is usually available online. The trial will then screen you to make sure you’re a good match. If you are a good match, you will be walked through the potential risks and benefits of the trial and all the details. This is called the informed consent process. During informed consent, make sure you ask any questions that are unclear to you and don’t sign anything until your questions are answered to your satisfaction.
- Don’t forget that even after you are enrolled in a trial, you can leave it any time you want.
Who funds clinical trials?
- Clinical trials can be funded by a variety of sources ranging from the US government (NIH/NCI), pharmaceutical companies, non-profit organizations, or patient groups
If the clinical trial failed to provide effective tumors relieve Can patient get to another clinical trial?
If yes,
what is the time between clinical trial prior entering another one?? Does the patient able to have chemotherapy in between clinical trials?
Hi, Andree. Thank you for reaching out!
The ability for a patient to join a second clinical trial would be dependent on the inclusion criteria for the trial itself. If they allow the use of experimental treatments, then having been on a trial would not prevent a patient from joining another one. The time period between clinical trials could be as short as the trial’s specific washout period, the time prior to joining the trial that a patient must come off systemic treatment, which can be as short as 2 weeks but varies depending on the trial itself.
If a patient wishes to receive chemotherapy as a line of treatment between clinical trials, it could affect eligibility only if the new trial does not allow chemotherapy. It is also important to keep in mind that if a patient receives chemo and finds a new trial while still on chemo, they would still have to wait out the washout period and stop the chemotherapy before the washout period can begin.
If you have any specific questions about your lung cancer journey or interest in clinical trials, please call our HelpLine at 1-800-298-2436 and ask to speak to one of our LungMATCH specialists.