A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol

Oncologist. 2024 Jun 3;29(6):e843-e847. doi: 10.1093/oncolo/oyae062.


For cancer clinical trials that require central confirmation of tumor genomic profiling, exhaustion of tissue from standard-of-care testing may prevent enrollment. For Lung-MAP, a master protocol that requires results from a defined centralized clinical trial assay to assign patients to a therapeutic substudy, we developed a process to repurpose existing commercial vendor raw genomic data for eligibility: genomic data reanalysis (GDR). Molecular results for substudy assignment were successfully generated for 369 of the first 374 patients (98.7%) using GDR for Lung-MAP, with a median time from request to result of 9 days. During the same period, 691 of 791 (87.4%) tissue samples received successfully yielded results, in a median of 14 days beyond sample acquisition. GDR is a scalable bioinformatic pipeline that expedites reanalysis of existing data for clinical trials in which validated integral biomarker testing is required for participation.

Keywords: Lung-MAP; biomarker; clinical trial; eligibility; genomic profiling.

MeSH terms

  • Biomarkers, Tumor* / genetics
  • Genomics / methods
  • Humans
  • Lung Neoplasms* / genetics
  • Lung Neoplasms* / pathology
  • Sequence Analysis, DNA / methods
  • Sequence Analysis, DNA / standards


  • Biomarkers, Tumor