As We Get Smarter, So Do Clinical Trials

Jennifer King, Lung Cancer Alliance Director of Research and Science

Jennifer King, Lung Cancer Alliance Director of Research and Science

By Jennifer King, Lung Cancer Alliance Director of Science and Research

The information we have today about lung cancer – about diagnosis, staging, treatment and survivorship – is because we learned from the journeys of patients before you.  As a patient, an important way that you can be involved in research is to join a clinical trial. It may not just help you but could help others in the future, as well.

Today, I want to explain how clinical trials have been changing to help even more people. Now that we understand cancer better, researchers can use this knowledge to design smarter clinical trials that benefit more people and reach answers more quickly.  One type of new design is called an “umbrella” trial, because the trial covers multiple smaller trials underneath it (think of the smaller sub-studies as the spokes of the umbrella).  Patients with one specific type of disease enroll on the trial, but they are then assigned to one of several smaller studies (sub-studies) under the umbrella that is most appropriate for them.

A good example is the Lung-MAP trial for advanced squamous cell carcinoma, a type of non-small cell lung cancer.  If you have advanced squamous cell carcinoma, you may be able to join this trial, which will check your tumor tissue for certain gene changes that may be helping your cancer to grow and spread.  Depending on your personal results, you get assigned to the sub-study that is most likely to benefit you.  This is a win-win. You have a better chance of responding to the new drug being tested and researchers get more people with the exact tumor characteristics that they are looking for to enroll in each part of the trial.

The researchers running the trial are also able to change the sub-studies over time as we continue to learn more about treating cancer.  I was able to attend the Lung-MAP investigators meeting in June where they were discussing changes to the sub-studies now that Opdivo has been approved.  It was very clear how passionate the group was about making sure the research being done was best for the patients.  (An example discussion point: “Would patients want to go on the trial first or try Opdivo first?”)

Another important umbrella trial in lung cancer to consider is the ALCHEMIST trial for early stage lung cancer that can be treated by surgery.  Similar to LungMAP, there is genetic testing of the tumor. Those with certain changes to the EGFR or ALK genes will receive adjuvant (additional) therapy with drugs targeting these changes to see if these drugs will help keep the cancer from coming back.

Along with these newer umbrella trials that are specific to one cancer, there are also “basket” (also called “bucket”) trials that enroll patients with multiple cancer types. Basket/bucket trials enroll patients from many different cancers but then put them in “baskets” (sub-studies) based on the molecular profile of the tumor, not the type of cancer.  This goes hand in hand with the new, hot topic of precision medicine.

NCI-MATCH is a new basket trial from the National Institutes of Health that is now open across the country, assigning patients to drugs based on DNA sequencing of their tumor.  The American Society of Clinical Oncology is also starting a new clinical study called TAPUR later this year which allows patients to take drugs “off-label” (ie, a patient with lung cancer could take a drug approved for leukemia or melanoma) if the cancer has the type of  genetic change that the drug targets.  In both cases, it’s these precise changes in your cancer, not where it is located that determines the best trial therapy.

The key takeaway is that trial design is changing, for the better.  I was just talking with a pharmaceutical company executive in charge of a clinical trial program about how earlier in his career, a Phase I clinical trial was only to show if a drug was safe (not whether it worked).  Now they expect drugs to be truly helping people even in these early phases, because they are given to the right group of patients.

When evaluating your options for yourself or your loved ones, consider clinical trials and discuss them with your healthcare team.  You may be able to pay it forward and help us learn how to better treat lung cancer for everyone, including yourself. If you need help finding a trial, we have a Lung Cancer Clinical Trial Matching service that can be accessed online or through a phone navigator at 1-800-698-0931.

The following are great resources on the basics of clinical trials and why they are important, including LCA’s Understanding Clinical Trials brochure, the National Cancer Institute website and Cancer.Net’s PRE-ACT video series.