NCT06422143

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

Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 851 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.

Conditions

• Non-small Cell Lung Cancer
• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Intravenous (IV) infusion
BIOLOGICAL	sac-TMT	IV infusion
DRUG	Carboplatin	Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
DRUG	Paclitaxel	Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
DRUG	Nab-paclitaxel	Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.

Timeline

• Start date: 2024-06-10
• Primary completion: 2029-01-12
• Completion: 2031-02-12
• First posted: 2024-05-20
• Last updated: 2026-04-02

Locations

205 sites across 26 countries: United States, Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Peru, Poland, Romania, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study