drugset / Trial / NCT06170788

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)

NCT06170788

Phase 3 Recruiting 614 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

Summary

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 1.1 (RECIST 1.1) after initial treatment.

Timeline

Start
2023-12-15
Primary completion
2028-01-25
Completion
2030-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified Intravenous