Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy/IO for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients Not Enrolled in Clinical Trials

The PrE1702 data registry study presents a unique opportunity for research sites to be part of a major new initiative to collect data from patients who are receiving osimertinib for their lung cancer treatment outside of a clinical trial. What makes this project unique is that the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) will study these real-world data (RWD) alongside those from the EA5182 clinical trial comparing osimertinib with or without bevacizumab as initial treatment for patients with EGFR-mutant non-small cell lung cancer (NSCLC).

PrE1702 is the first prospective RWD study for patients with EGFR-mutated NSCLC, leveraging the research strengths and broad reach of this large cancer research group. Investigators expect to gain a better understanding of the impact of these commonly prescribed treatments, as well as create a roadmap to guide future RWD collection strategies.

Using RWD to broaden our understanding of the efficacy of treatment regimens is a current priority of the US Food and Drug Administration (FDA), and the agency is providing funding to ECOG-ACRIN and PrECOG to conduct PrE1702.

PrE1702’s non-randomized patient registry has a simple design, no monitoring or auditing, and minimal documentation requirements. Baseline demographic, treatment, and toxicity data from consenting patients are abstracted from their electronic medical record (EMR) and entered into the clinical database, Medidata Rave. Patients will also be offered a short, 8-question FACT-L quality of life measure for completion. Treatment and patient follow-up for survival is every 3-6 months per standard of care, and the protocol does not dictate when patients are seen or imaged.

Additionally, the treatment regimen is the choice of the physician and patient at registration: (1) osimertinib alone or (2) osimertinib plus chemotherapy or immunotherapy. Notably, the PrE1702 data collection will request information on why the physician and patient chose monotherapy or the combination. The circumstances they describe will enhance understanding of the real-world settings that impact treatment selection—information that will be extremely beneficial for future patients.

Planned enrollment is 538 patients, with approximately 250 patients in each of the two groups. To be eligible for PrE1702, participants must have EGFR-mutated NSCLC that has spread to nearby lymph nodes or tissue, and/or has spread inside or outside of the lungs. The study is ideal for research sites to offer to patients who were screened for clinical trials but were not eligible or did not enroll for whatever reason.

The use of RWD is becoming increasingly important in today’s healthcare decision-making, and there is an urgent need to better understand what happens to patients treated outside of a clinical trial—a fact underscored by study chair Suzanne Cole, MD, when she presented PrE1702 at multiple sessions during the recent ECOG-ACRIN Fall Group Meeting: “Your 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.”

Learn more about PrE1702 at ecog-acrin.org.

Sites interested in opening PrE1702 can email the study chair Suzanne Cole, MD (UT Southwestern/Simmons Comprehensive Cancer Center), the study co-chair Maya Khalil, MD (University of Alabama/UAB Comprehensive Cancer Center), or Al B. Benson, III, MD, ECOG-ACRIN’s Real-World Data Committee Chair (Northwestern University/Lurie Comprehensive Cancer Center).