What It's Like to Be in a Lung Cancer Clinical Trial - Part One, Background Information

Have you ever thought about participating in a lung cancer clinical trial? The thought of taking an experimental drug, a new combination of drugs, or undergoing a new surgical or radiological procedure is exciting for some, scary for others. If you think a clinical trial might be in your future, I hope to bolster your interest with some information, and to soothe your fears. I was in a phase II trial of an experimental lung cancer drug for 8 months, and I believe it was a very good treatment choice for my situation.

First, we need some basic information. There are three types of clinical trials in cancer research, and it’s important to understand which type a particular trial is before signing on:

* Phase I trials test brand new treatments that humans have not used before to find out if a potential treatment is safe and what its side effects are. Drugs are tested for appropriate dosage and how they should be taken. These trials involve very small groups of patients, and these patients are the true pioneers.

* Phase II trials test a treatment in a larger group of patients to see if if actually works and to continue to monitor safety and side effects. In my opinion, phase II trials can be a sweet spot in the clinical trial process if there is good initial data on effectiveness.

* Phase III trials test the treatment in a large group of people and compare it to a standard treatment to see if it is an improvement in care over what is currently available. Patients are usually assigned at random to a particular treatment. Safety continues to be a major concern, and patients are closely monitored.

An important question is who pays for the costs of treatments, testing, and care that are part of the trial. If you are inquiring about a particular lung cancer clinical trial, this is one of the first things to ask about. In the U.S., clinical trials are often paid for by a partnership between the trial sponsor and the patient’s health insurance. In my case, insurance paid for everything that was part of my standard care, such as blood tests and scans, and the sponsor paid for everything special, such as specialized genomic and blood tests, plus provided the experimental drug at no cost. Make sure that you get detailed information on who will pay for what, because each trial is different. Also find out if the trial site is in network with your health insurance company, because that could have a major impact on how much a clinical trial might cost you out of pocket.

We all can imagine that being in a clinical trial could mean that we get to benefit from an amazing new lung cancer treatment before it becomes available to the rest of the world. Another very real advantage is that you get the best of care. When I was in a trial, I had blood tests, EKGs, and a consultation with my research oncologist every three weeks. Even if the treatment doesn’t work for you, you will be so closely monitored that you and your medical team will know that right away and you will be able to move on to a new treatment plan.

The greatest fear that patients seem to have about clinical trials is that they will be given a placebo that will have no effect on their cancer. That never happens in trials for lung cancer patients - it would be unethical. If you do not receive an experimental treatment in a trial, you will receive standard of care, plus you will be more closely watched than if you were receiving that treatment outside of a trial.

The National Institutes of Health estimates that only about 3% of all adult cancer patients participate in a clinical trial, and the participation rate may be even lower for lung cancer patients. To be able to enroll in a clinical trial requires being in the right place at the right time, with the right diagnosis and treatment history. While helping patients is the first objective of a trial, they have to be designed both for safety and to produce statistically valid results, and they will exclude patients with certain pre-existing conditions and certain prior treatments. If you can find a trial that matches your medical history, the next hurdle is getting to where the trial is being offered. Most trials are offered at major research hospitals, making it harder for people in smaller cities and rural areas to participate. There are reasons for that; one issue is making sure that tests and scans are done in the same way at all clinical trial sites. The powers that be recognize that lack of access is a problem, and are working on ways to offer more trials at community cancer centers. The NCI-MATCH study is an example of a trial that has been carefully designed to be able to be offered at community cancer centers as well as major cancer centers.

In Part Two I’ll describe what the clinical trial I was in was like, including the enrollment process, how I was cared for, and what I was required to do in return for a treatment that possibly extended my life by several months.

For more information, Free to Breathe has an excellent web page about lung cancer clinical trials. Check out the clinical trial finder at the bottom of the web page! freetobreathe.org/lung-canc...

Other good references:

NIH Clinical Trials and You - The Basics: nih.gov/health-information/...

NCI-MATCH: cancer.gov/about-cancer/tre...

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10 Replies

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  • There is so much that I had not considered. My oncologist knows that I will participate in a clinical trial in the event of progression.

    Seriously, is not considered the in network thing. Thanks Anita! I'm going to bookmark this for future reference.

  • Denise, glad this was helpful. Yes, we kind of assume that the trial sponsor pays for absolutely everything, and sometimes that may be true, but in most cases the sponsor is only paying for a portion of the costs. Our mutual friend Linnea has an ongoing bone of contention because in three phase I trials, not once has a sponsor paid for her parking. Seems petty, but it's a real cost to the patient.

    If the trial site is not in your insurance network, you could find yourself with some hefty bills in short order.

    Anita

  • Wow, I think it is awesome that you are one of the people that have/are doing the clinical trails & can't wait to see the next part.....

    Since I found out I've thought of trying to get into some of the clinical trails EXCEPT..I've got more & more medical issues happening...my worse thought is I CAN'T DO THEM Because I've got major allergies (can't do any of the scan dyes, when I need to knocked out for a biopsy & such it takes mega long to come out of it, very slow, slow healer, bruise easy & lasts a long time, blood type strange RH- unsure if I could even do/get a blood transfusion, (basically the doctor's have so much said all they can do is keep me comfortable).....I have always thought about asking if there is clinical trials for people like me of which would be being allergic to the scan dyes---(not being able to use the dyes makes it so much harder for the doctors to see the full extent), but I also feel there have got to be others allergic to the dyes & what is being done to help find other options....When I mentioned about trying a clinical trail my lung specialist said there are none with all my issues that (even if doing for being allergic to the dyes) that my other medical issues would make doing them harder to work with & would not suggest one for fear it could hurt me even more or cause things to grow/move even faster......(just in the last 6 months there are major changes to my lungs, kidney, intestines, colon, bladder & such are trying to shut down, eye problems happened real fast, and such...

    I am excited & looking forward to your next part....will try looking into information on the clinical trails (would my lung specialist have to allow me to do them or anything like that)...

  • Terri,

    Your oncologist is being honest with you. Every trial has a list of exclusions, and often you have to be in pretty good shape to be able to participate. When they don't know how a new drug is going to affect people, investigators are very concerned about giving you something that might make you even sicker than you are. As an example: I have MS, have been in remission for more than a decade, but I would not be allowed to enter any immunology trial I've looked at. They exclude people with auto-immune disorders because they are afraid the immunology drugs will cause the the disorders to flare up. I've just heard about another long awaited trial that is on hold because the very first patient to take the drug combination being tested had a cardiac event.

    Anita

  • Anita thanks & never thought of what my doctor was saying was actually right & watching for my well being....wow, with the very first person having a cardiac event that would really make me wonder & be more watchful for things happening & yes, agree that it should be on hold also (until they can find out what caused the cardiac event), maybe the person had underlying issues that no one knew about.......thanks again

  • Nice article Anita , lots of great info

    RW

  • Thanks RW. Hope you are hanging in there!

  • Anita I contacted the clinical trial that there trying to get people to do. It is a stage three for adnocarcinoma. A Lady called me back and we had a long talk. Since i'm cancer free they don't have a trial for me. She said she would keep in touch because evetully they would have a drug that would keep you cancer free. I thought that would be great.Hopfully it will happen soon. Jo

  • Wow, wouldn't that be wonderful, Jo!

  • Anita I didn't contact them for myself I wanted to know what it was for and if it would help any of the others. It is atrial three for adnocarcinoma I was hoping it would help someone on here. Healthunlocked is promoting it. I hope someone on here might do it. Jo

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