Ongoing Trials in the Adjuvant Setting in Early Non-Small Cell Lung Cancer


Dr. Jessica Donington provides an overview of key ongoing clinical trials of systemic adjuvant therapy in early non-small cell lung cancer.

Jessica Donington, M.D., M.S.C.R.: When we look at where we’re going in terms of systemic therapy and adjuvant therapy for resected patients, cancer immunotherapies are probably the biggest area of interest right now. There are several trials looking at the use of targeted therapies for patients with resected tumors that carry less frequent mutations than EGFR [epidermal growth factor receptor]. And those are typically things like ALK [anaplastic lymphoma kinase] and ROS [reactive oxygen species]. While we see EGFR mutations in about 10% to 15% of patients in the United States, those other mutations are more like 1%, 2%, 3%, maybe even 5%, but that’s it. There’s about 10 other targets out there, each 1% or 2% of the population. Again, trials that span the whole country to find as many patients as possible. With the cancer immunotherapy trials, there are quite a few of that. Cancer immunotherapies, there’s somewhere between five and six agents available in the United States in three different categories and many of those have trials, which are available here in the United States and throughout the world. And there are several trials that look at it the same way, the IMpower0101 does, looking at it after resection and after chemotherapy. And then we also have some trials which are starting to look at it, maybe we give the immunotherapy with the chemotherapy, or maybe we give it instead. Most of the, what we call inclusion criteria, those patients who are eligible for the trials is similar. We’re looking at that same population of patients with big tumors, without lymph nodes, all the way through to tumors that have mediastinal lymph nodes. And most people must undergo a standard operation and get out of it well. We are also looking, and it is a very exciting place also, about what if we give the cancer immunotherapies before surgery. And there is kind of some exciting thought, that if you can release the immune system and teach it what the tumor looks like, while the big tumor is in there, that we might — the immune system might do a better job at recognizing and finding those cells which have escaped. What we call the neoadjuvant space, or the space before surgery, is also incredibly popular for cancer immunotherapies. And there have been some trials which have already been reported with impressive results and there are many more that are ongoing. For those of us who treat lung cancer, we’ll be talking about whether the treatments before or after for a very long time. We’re probably going to have that conversation for the next five years or so. While we all agree that there’s going to be a huge population of patients who should be getting chemotherapy and cancer immunotherapies, how we deliver those therapies, in what order, for which patients, is kind of where the conversations are going. And I think another part of the conversation will eventually be, does everyone need the chemotherapy or do some people just need the immunotherapy? Do some people maybe need two immunotherapies? This is very unclear, but as Dr Dietrich mentioned, these are the questions we have been asking over the last five years in stage 4 disease. Do the same patterns hold for earlier stage disease? And they probably do. We need to ask the same questions and we probably need to use the same set of biomarkers to help decide who gets which treatment going forward. But it does increase again, the importance of good biopsies, good staging, and molecular analysis, even before you start your treatment. And one thing that’s challenging for patients about that, is that all of those steps take time. It’s additional procedures and it’s additional time, but it’s more important than ever to not start necessarily as quick as you can, but to find the most accurate treatment and to start on the correct path for you and your tumor is probably [of] utmost importance as we move forward. I know it’s challenging for my patients who just want their tumor out and they want it out yesterday. And I’m going to tell you that you need a PET [positron emission tomography] scan and EBUS [endobronchial ultrasound], then we’re going to wait 10 days to get the molecular analysis back. And then we’re going to take it to the board, and then we’re going to give you a treatment. But those are all the steps that we need in 2021 to tailor a treatment ideally for each patient and their tumors.

Transcript edited for clarity.

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