Real-World vs Clinical Trial Biomarker Testing in Early-Stage NSCLC

Although biomarker testing in early-stage non-small cell lung cancer has improved, some patients still do not receive full, guideline-recommended testing, according to Dr. Sandip Patel, a professor of Medical Oncology at University of California, San Diego (UCSD), who added that this points to a gap between clinical trial practices and everyday care.

He sat down for an interview with CURE to discuss findings from a real-world study of biomarker testing in early-stage resected non-small cell lung cancer in the U.S. These data were shared at IASLC 2025 World Conference on Lung Cancer and investigated how testing in everyday practice compares with clinical trials.

At UC San Diego Moores Cancer Center, Patel also serves as the leader of Experimental Therapeutics, deputy director of the Sanford Stem Cell Clinical Center, co-leader of Solid Tumor Therapeutics, and medical director of Clinical Research Informatics.

Transcript

What prompted you to explore real-world data on biomarker testing in early-stage lung cancer?

Historically, clinical trials looked at biomarker testing. That's really the tip of the iceberg. Most of oncology practice is kind of ‘underwater,’ in the sense that we don't see what happens, and real-world evidence is the way for us to kind of peer into that ocean a bit. What's done in a clinical trial or what's done in a published report is very different than what is seen in real practice.

We look at a Flatiron database on real-world testing in non-small cell lung cancer. Increasingly, as you mentioned, precision oncology methods have moved from just the metastatic setting, where they remain important, to now increasingly in the early-stage setting where we're trying to maximize cure rates or at least hold off relapses as long as possible. Those precision methods and those DNA tests and immune staining remain very important, for example, for PD-L1 testing for EGFR, ALK and ROS1, at the very least.

We want to see what real-world practice was like, since that’s where most patients are treated, in the community setting. And we found that over time, there's been improvement in testing rates, including in early-stage disease. But I think we can do more, and there are probably about 10 to 15% or 20% of patients that are not getting the full, appropriate testing in the curative-intent setting.

Trying to understand why and how we can help those patients is the next step to make sure that we can offer these treatments for patients. Because if we have targeted therapy of immunotherapy, you can only use targeted therapy effectively if you look for the target.

We don't want to be guessing; we want to be testing. We want to do this in the metastatic setting and in the early-stage setting. We want to find those barriers. Are they financial barriers? Are there logistical barriers? Are there practice-based barriers to get the test done? Because once we understand those problems, we can help that last group make sure to get the precision oncology treatments they deserve in the early-stage setting as well.

Transcript has been edited for clarity and conciseness.

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