Clinical Trial 21586

• Overview

  Study Title:

  LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer

  Summary:

  The primary purpose of this testing is to determine the presence of 10 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, and HER2, rearrangements in ALK, RET, NTRK, and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected.

  Objective:

  Primary Objective: The primary objective of this study is to determine the proportion of patients with stage IA2-III lung cancers who possess actionable oncogenic drivers. The screening approach will be considered feasible if, utilizing tumor or plasma assays, 35% of non-squamous non-small cell lung cancers are identified as having a actionable genomic alteration including ALK rearrangements, BRAFV600E mutations, EGFR sensitizing mutations, HER2 mutation, HER2 amplification, MET amplification, MET exon 14 mutation, RET rearrangements, NTRK rearrangement, KRAS G12C, or ROS1 rearrangements. Secondary Objective Measure Tumor Mutation Burden (TMB) in all patient tumor samples (mutations per megabase)

• Inclusion Criteria

  • Clinical stage IA2-III lung cancers
  • Potentially resectable if lung cancer suspicion confirmed pathologically
  • Operable

• Exclusion Criteria

  • No concurrent malignancy
  • No prior lung cancer within last 2 years
  • Purely ground glass pulmonary opacity

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