Osimertinib Trial for EGFR-mutant NSCLC Reaches Primary Completion

The Phase 3 ECTOP-1022 study (NCT06323148) investigating osimertinib in patients with EGFR-mutant II-IIIA non-small cell lung cancer reached its primary completion on 2026-03-31. This milestone indicates the completion of data collection for the study's primary outcome measures.

Background

The study focuses on patients with EGFR-mutant non-small cell lung cancer (NSCLC), specifically those with stage II-IIIA disease who have undergone radical surgery. The trial aims to assess the role of osimertinib as an adjuvant therapy guided by circulating tumor DNA (ctDNA) minimal residual disease (MRD) status.

Trial design

The ECTOP-1022 study (NCT06323148) is a Phase 3 trial with an estimated enrollment of 226 participants. It investigates the use of osimertinib as an adjuvant target therapy. The study population includes patients with lung cancer, specifically those with an EGFR gene mutation and detectable minimal residual disease after surgery. Patients with positive ctDNA testing will receive standard treatment, and then those with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either an observation follow-up group or an osimertinib adjuvant treatment group. The interventions include osimertinib and no adjuvant therapy.

What this means

The primary completion of the ECTOP-1022 trial signifies a significant step towards understanding the potential role of osimertinib in a ctDNA-guided adjuvant setting for EGFR-mutant II-IIIA NSCLC. While results are not yet available, this milestone indicates that the main data collection period for the study's primary endpoints has concluded. The findings from this study are anticipated to provide crucial insights into personalized treatment strategies for this patient population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06323148, titled "Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)," was posted on 2026-03-31 on clinicaltrials.gov.