Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.

Trial Details

NCT ID
NCT06170788
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Sacituzumab tirumotecan
  • Pembrolizumab
  • Supportive care measures
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Burbank, California, United States|34.18084,-118.30897
  • Grand Junction, Colorado, United States|39.06387,-108.55065
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Marietta, Georgia, United States|33.9526,-84.54993

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
  • Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS…
  • Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemi…
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.

For full eligibility, visit ClinicalTrials.gov.

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