Clinical Trial

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)

Study acronym: TroFuse-007
Recruiting Phase 3
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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.
Protocol Amendment History 80 amendments
This ClinicalTrials.gov record has been amended 80 times since 2023-12-06; most recent amendment 2026-07-17.
Status change: Not Yet Recruiting → Recruiting 2024-01-04
Trial Details
NCT Number NCT06170788
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 614 participants
Start Date 2023-12-15
Primary Completion 2028-01-25 (estimated)
Study Completion 2030-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-30