Lung Cancer Trials Require Modified Eligibility Criteria to Better Reflect Real-World Population

The evolution of clinical trial enrollment criteria to more accurately represent real-world lung cancer populations will be contingent on cooperation and innovation from members of the entire oncology community, including researchers, community oncologists, and trial sponsors, according to Edward S. Kim, MD, MBA.

“If you're investing [resources] and putting trials in the community, let's make sure that when patients come through the door, they're eligible,” Kim said in an interview with OncLive^® during the 24th Annual International Lung Cancer Congress®.

In the interview, Kim discussed key points from his presentation on the connections between clinical trial designs and patient representation in lung cancer research, highlighting necessary changes that would make cancer research more accessible to patients in community settings; multidisciplinary efforts that should take place at every step of the trial design and implementation process; and how future clinical trials should be intentional about the patient demographics.

Kim is the physician-in-chief of City of Hope Orange County and the vice physician-in-chief of City of Hope National Medical Center in Duarte, California

OncLive: What were the key focus points from your presentation on how changes in clinical trial designs could improve representation in lung cancer trials?

Kim: There has been so much innovation across oncology. [People are no longer] asking: When will we cure cancer? Many patients are cured. [Patients] are living with stage IV disease. [Patients] are being cured [through] prevention [or in] earlier stages [of disease]. The clinical trials that have led to this have all encompassed what we see today.

However, we can do better. We are not as good about being inclusive of all races, genders, ethnicities, and rural populations in these clinical trials. We hear the term “real-world populations.” Who comes through the door? Who needs help? We need to give these patients access to these cutting-edge clinical trials. The academic, high-powered centers are important for driving innovation and research, but 85% of patients who are treated [receive treatment] in community-based centers. We need to figure this out.

One area that I've been trying to champion and move forward is changing eligibility criteria. If we're going to achieve inclusive research, we need to be scientifically based in how we choose who should be in a trial, instead of cutting and pasting up to 40 different eligibility criteria. That's tough.

How can researchers, clinicians, and trial sponsors work together to design clinical trials that are more accessible for underrepresented groups?

Trying to increase representation and inclusivity in these trials is a multifactorial issue that will take multiple ways to solve. One way is that we must be purposeful in how we place trials into locations where there is not usually much access. That costs money and resources. I grew up in a small town in Indiana, and anytime we needed advanced health care, we needed to drive to Chicago, [Illinois], or Indianapolis.

Nothing could be more frustrating or self-serving than putting a trial with tough eligibility criteria into a rural place. You've invested money and resources, and now these patients cannot enroll. We can be better. We need geographic access.

[Additionally], more trial designs are allowing just-in-time [methods] or other [parameters]. Now, we need providers in the community centers to have access to these trials.

Finally, we need to write the trials. When you're sitting at the table, whether you're a sponsor, a young investigator, or a senior investigator, look at those eligibility criteria. The statistics section, adverse effects section, and calendar are important, but we find many unnecessary and scientifically invalid eligibility criteria. [The concept of revising these criteria] has been embraced by the National Cancer Institute Cancer Therapy Evaluation Program and the FDA, as well as multiple advocacy groups such as ASCO and Friends of Cancer Research. We published our most recent set of recommendations in the AACR journal. [Many] different groups [acknowledge] that this is a necessary change.

What resources does City of Hope offer to patients to improve representation in clinical trials?

City of Hope is uniquely placed. It's based in Duarte, [California]. It's been there [for approximately] 100 years and is an NCI-designated center, a center of innovation and research. However, we're expanding. I have been helping to lead the Irvine Campus development. Irvine, [California] brings a whole new demographic. [There], approximately 30% of patients are Asian-American and Pacific Islander, and approximately 35% of patients are Hispanic. We're seeing different populations.

We're now growing into south Atlanta, [Georgia], where the demographics are rural and African American. In Phoenix, [Arizona], [many patients are] Hispanic and [Native American, a population that has not been] studied deeply. North Chicago has a totally different demographic as well.

Our job is to make our clinical trials accessible to these populations and focus on enrollments there. This is the future. We are a connected system. That's what we hope to achieve with opening clinical trials and research across all these geographies, so we can be inclusive with our representation.

In the future, how might clinical trials delineate patient characteristics such as race and ethnicity for the purposes of wider representation that is more accurate to real-world populations?

Clinical trials should absolutely represent our population. Consider the question of ethnicity, race, and genomics: there are arguments that [these are] not just based on skin color or heritage, and genomics should drive ancestry. That's why [the tests that reveal] genetic linkages are popular because people are not sure what race they are until they see that genetic linkage.

Do I think we will get there one day? Absolutely. Do I think we need to be purposeful about the types of populations, geographic [and beyond, that we enroll]? Yes. Right now, [the categories include] the United States, the East, the West, and Europe. [Although we need] to start broad, we can get more specific. We're seeing companies do this. One company has opened a clinical trial in Africa in a disease that is more endemic and populous among that [region]. It's groundbreaking. That's the type of thing we need to be purposefully doing.

Reference

Kim ES. Changes in clinical trial designs to improve representations (pragmatic trial designs and real-world). Presented at: 24th Annual International Lung Cancer Congress; July 27-29, 2023; Huntington Beach, CA.