Clinical Trial

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17, D763QC00001)

MOA: Datopotamab Deruxtecan (Dato-DXd) is an ADC targeting TROP2 containing a topoisomerase I inhibitor payload

Key Eligibility Criteria:

• Documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC without AGA at the time of randomization
  • Must have negative test results for EGFR, ALK, ROS1 genomic alterations
  • No known tumor genomic alterations in NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, HER2 or any AGA with approved targeted tx
  • KRAS mutations, with exception of G12C, are eligible
• Radiographic PD on/after most recent tx for adv/met NSCLC
• 1-2 prior lines of tx with plt-based chemo + anti-PD-(L)1 combined or sequentially (in any order)
  • Prior tx with docetaxel excluded
  • Prior tx with any anti-TROP2 agent excluded
• Must provide FFPE tumor sample for assessment of TROP2
• Spinal cord compression or brain metastases excluded
  • If asymptomatic, stable, and without corticosteroids or anticonvulsants for at least 7 days prior to randomization are eligible
• At least 1 measurable lesion per RECIST v1.1