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Now Enrolling: This lung cancer patient registry study by PrECOG aims to better understand an FDA-approved treatment

Lung x-ray on iPad

PrE1702, a new patient registry study and the first of its kind from PrECOG, LLC., is building momentum after enrolling its first patient in September 2024. A patient registry is a database that collects and stores information about people diagnosed with a specific disease or condition. This type of study differs from a traditional, treatment-based clinical trial in several ways:

  • It does not test a new therapy, but instead simply records information about patients’ experiences and the medical care they receive as part of the usual care for their cancer
  • It does not require that participants take a certain treatment or follow a specific study plan
  • Usually, there is no need for extra involvement from medical insurance

By analyzing registry data, researchers can better understand the impact of new treatments and their effectiveness over time. Researchers can also study side effects over time, including those that may not have been identified in prior trials. And, because patient registries typically have broad eligibility criteria, they can show the effects of new treatments in a more diverse and representative population than that of a clinical trial—a population that more closely resembles the “real world.”

Accordingly, the data collected in patient registries is often referred to as real-world data and any findings as real-world evidence. Examples of data collected in a registry include patient demographics, medical history, social history, treatments, health status, and side effects. To protect confidentiality, the data is de-identified, which means any information that could reveal the patients’ identities is removed.

The PrE1702 study is collecting real-world data on patients with advanced non-small cell lung cancer (NSCLC) with the EGFR tumor gene mutation. These patients usually receive treatment with a drug called Tagrisso® (generic name osimertinib), a type of targeted therapy that has been approved by the US Food and Drug Administration (FDA). Sometimes patients receive osimertinib together with chemotherapy, and sometimes osimertinib together with immunotherapy. Each patient’s doctor decides on the specific treatment that is best for that individual.

The goal is to learn whether the therapies have the same benefits for patients who may not have had the opportunity, wanted to, or been eligible to enroll in a trial. Researchers will also study the impact of these treatments on patients of various ages, races/ethnicities, and health conditions. Up to 538 patients will participate in the registry, approximately 250 receiving osimertinib only and approximately 250 receiving osimertinib with either chemotherapy or immunotherapy.

To participate in the study, patients simply sign a consent form authorizing that the required data may be collected from their medical records. They will also complete short research questionnaires up to five times. All patients will be followed by their doctor every 3-6 months for up to three years after they finish treatment.

“Participation in this registry will help us to care for all the patients in the real world who are not represented in clinical trials but need safe and effective cancer therapies,” said PrE1702 Study Chair Suzanne Cole, MD, from The University of Texas Southwestern Medical Center.

Learn more about the PrE1702 study at ecog-acrin.org.


PrECOG, LLC. is a cancer research group that aligns with and supports the scientific goals of the ECOG-ACRIN Cancer Research Group.

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