A GENE-BASED assay may help guide adjuvant chemotherapy decisions in early-stage non-squamous non-small cell lung cancer (NSCLC), according to interim results from a randomized clinical trial presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
The study enrolled 421 patients with stage IA–IIA non-squamous NSCLC who had undergone surgical resection. Researchers used a 14-gene assay, RiskReveal, to stratify tumors into low-, intermediate-, and high-risk categories. Among 194 patients categorized as intermediate- or high-risk and evaluable for this analysis, 87 were randomized to receive four cycles of platinum-based chemotherapy, and 107 to observation.
After 24 months, disease recurrence had occurred in fewer patients receiving chemotherapy compared to those under observation. Specifically, 96% of the chemotherapy group had no cancer recurrence versus 79% in the observation group. This translated to a 78% lower risk of recurrence for those who received chemotherapy. The median disease-free survival had not been reached in either group at the time of the analysis.
This prospective trial is the first of its scale to evaluate whether a commercially available molecular assay can identify early-stage NSCLC patients who may benefit from adjuvant chemotherapy, even when clinical features alone might not indicate the need for additional treatment. The investigators noted that around 55% of participants had stage IA NSCLC, a group not routinely considered for adjuvant chemotherapy based on current standards.
Based on the interim efficacy data, the trial’s Data Safety Monitoring Board recommended halting further enrollment. Follow-up continues for those already participating. The research team plans to explore how molecular profiling may intersect with targeted and immunotherapies in early-stage disease.
While these early findings suggest that molecular assays may support more individualized decisions following NSCLC surgery, long-term follow-up and full trial results will be needed to assess overall impact on survival outcomes.
Reference:
ASCO. May 31, 2025. Available at: https://asco1.sharefile.com/share/view/6ee8af44187f42b3/fod471b5-6c79-44e5-babd-39022782c4e4. Last accessed: 1 June 2025.
