Metabolic Signatures Predictive of Response to Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Studied in Phase 2 Trial

Strategic Insights -

Researchers at a leading institution are conducting a Phase 2 clinical trial to investigate metabolic glycolytic biomarkers predictive of response to neoadjuvant immunotherapy in non-small cell lung cancer (NSCLC). The trial, led by Saulo B. Silva, Associate Professor, MD, PhD, aims to develop a practical diagnostic approach to improve patient selection for immunotherapy. The study, currently open for recruiting 30 participants from the USA, will evaluate the relationship between glycolytic biomarkers and pathological response after two cycles of neoadjuvant nivolumab combined with platinum-based chemotherapy.

Key Takeaways:

  • The trial involves 30 patients with early-stage NSCLC (stage IB to IIIA) and aims to investigate metabolic glycolytic biomarkers predictive of response to neoadjuvant immunotherapy.
  • The study will measure baseline metabolic tumor volume (MTV) and SUVmax using PET/CT scans, while IHC markers and molecular profiling will be performed on pre-treatment biopsy samples.
  • The primary outcomes include major pathological response (<=10% viable tumor cells) and immune profile characterization (IHC for CD8, CD4, FOXP3, PD-1, CD68, CD163).
  • Secondary outcomes include event-free survival and treatment toxicity.
  • The study is expected to support a more cost-effective immunotherapy regimen for early-stage NSCLC.

Statistics:

  • 30 participants from the USA will be enrolled in the trial.
  • The study will evaluate the relationship between glycolytic biomarkers and pathological response after two cycles of neoadjuvant nivolumab combined with platinum-based chemotherapy.
  • The primary outcome of major pathological response will be measured using histopathological evaluation.
  • Secondary outcomes will include event-free survival measured at 6-month follow-up.

Sources:

  • ClinicalTrials.gov (NCT07084610)