If you’re receiving top-notch care for advanced lung cancer, your oncologist should be talking with you about clinical trials. Clinical trials are tests, in human patients, of new medications, new combinations of medications, and/or new approaches to treatment. While it might sound scary at first to receive a medication or treatment that is still being tested, sometimes it is the only way to get access to the most effective treatment for your particular cancer. (If the term “clinical trials” hasn’t even come up in conversation with your oncologist, consider looking for a better one.)
This is because lung cancer treatment is changing so rapidly. New and promising approaches to treating lung cancer are being discovered all the time. Sometimes, although a medication or approach to treatment is still in clinical trials, there’s already good evidence that it is safe and works better than standard care for certain patients. Sometimes a medication or treatment has been around for a while and is known to be safe and have few side effects, but is being tested in combination with standard lung cancer care. In these cases, the risks can be low and the promise of greater effectiveness can be high – especially in the treatment of advanced lung cancer, where standard treatment is, unfortunately, still pretty limited in its effectiveness against the disease.
In the lab, a drug may seem to have promising cancer-fighting properties. Scientists can’t know for sure how it will work in humans, though, until humans try it. Therefore, the Food and Drug Administration requires carefully regulated tests of drugs in human patients to determine how safe and effective they are.
Clinical trials of new drugs and treatments proceed through three phases. In Phase I, a very small group of people are given the drug or treatment for the first time to determine safety, dosing, and side effects. In Phase II, a larger group of people receive the drug or treatment to evaluate its effectiveness. Finally, in Phase III, a large group of people receive the drug or treatment to confirm its effectiveness, compare it to commonly available treatments, and monitor its side effects. Drugs and treatments have to make it through all three phases before they can be approved for marketing. In every phase, if a drug turns out to be too toxic, the trial is halted and researchers return to the drawing board. There is also a Phase IV, consisting of studies done after the drug or treatment is on the market to evaluate long-term effects in various populations. (This description of the four phases is paraphrased from information provided by the National Institutes of Health at http://www.nlm.nih.gov/services/ctphases.html)
The number of clinical trials going on at any one time is quite overwhelming, even just the clinical trials for lung cancer treatments. All current clinical trials are listed in a public database at www.clinicaltrials.gov, which anyone can access. Some patients become very adept at learning about clinical trials, zeroing in on the ones that seem most promising for them, and getting enrolled even if it means going to a distant city for care. More often, your oncologist becomes the guide to the clinical trials in which he or she is able to enroll patients, identifying which ones make the best sense for you. Large cancer centers generally have access to more clinical trials than small ones; at some point, your local oncologist may recommend getting seen at a bigger center to find out what trials they have available.
In my short career as an advanced lung cancer patient, I’ve already been in three clinical trials. The first one was a study of a safe, commonly used antimalarial drug that has been around forever but was recently discovered to have potential cancer-fighting properties; I took it in combination with standard chemotherapy at Rutgers Cancer Institute of New Jersey. I dropped out of that study when Dr. Saraiya recommended briefly stopping my chemotherapy for some additional testing.
The second was a study of a PD-L1 inhibitor, a compound thought to enhance the cancer-fighting ability of the body’s own immune system. I was enrolled in this study through Memorial-Sloan Kettering Cancer Center, but not for very long. The first step was finding out if my tumor had the PD-L1 protein – even the test for the protein was experimental, so I had to be in the trial to be tested. I didn’t have the protein, so that was that.
Currently I am in a study of crizotinib, the drug on which I am now doing so well. I am also enrolled in this one through Memorial-Sloan Kettering. This is one is a bit confusing because it’s actually a Phase I study, even though crizotinib is now on the market under the name Xalkori. My doctor at Memorial-Sloan Kettering explained to me that sometimes, even when a drug has already “passed” one or more phases of testing, researchers keep enrolling patients in early-phase trials. This way, they can continue to collect important data without having to get a whole new trial approved.
I find it exciting to be in clinical trials. I feel like I’m on the cutting edge of medicine; even though I’m not a doctor or a scientist, I’m helping develop better treatments for cancer by trying them.
The National Institutes of Health provides a list of Frequently Asked Questions about clinical trials here: http://www.nlm.nih.gov/services/faqctgov.html