drugset / Trial / NCT06422143

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

NCT06422143

Phase 3 Recruiting 851 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Timeline

Start
2024-06-10
Primary completion
2029-01-12
Completion
2031-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous