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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, January 15, 2025
Hushan Zhang, PhD, of Zhaotong Health Vocational College, Yunnan, China, and colleagues aim to conduct a study that evaluates the clinical relevance of detecting postoperative measurable residual disease (MRD) via circulating tumor DNA (ctDNA) to influence adjuvant treatment options in patients with non–small cell lung cancer (NSCLC), who carry a potentially high risk of recurrence. The proposed protocol for this study, which focuses on patients with resected EGFR-mutated NSCLC, was published in the American Journal of Cancer Research.
“This study [will provide] crucial insights into therapy guidance for EGFR-mutated NSCLC patients with MRD, potentially enhancing patient outcomes,” the study authors mentioned. “The findings from this study have the potential to significantly impact clinical practice by providing valuable information on postoperative recurrence risk prediction and guidance for therapy strategy in EGFR-mutated NSCLC patients with MRD, ultimately improving patient outcomes and survival rates.”
This open-label, randomized, controlled trial plans to enroll 1,068 adults with stage IA to IIA NSCLC who harbor an EGFR mutation and negative resection margins. Participants will be randomly assigned 1:1 to receive adjuvant treatment with osimertinib or to remain under observation. A crucial parameter is that if the patient’s peripheral blood sample is negative for ctDNA after next-generation sequencing, postoperative observation and follow-up alone will be appropriate. If the sample is positive for ctDNA, however, the individual will be randomly assigned to treatment or observation.
The primary endpoint of this trial is progression-free survival among patients with early-stage, EGFR-mutated, resected NSCLC receiving MRD-guided, adjuvant osimertinib. Secondary endpoints include 2- and 5-year progression-free survival rates, as well as quality of life, which was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Notable safety endpoints include the frequency of all, grade 3 or higher, and serious adverse events, as well as adverse events leading to treatment discontinuation or suspension.
Disclosure: The study authors reported no conflicts of interest.
American Journal of Cancer Research
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