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Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

NCT05609968 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2025-12-24

No results posted yet for this study

Summary

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

Sacituzumab Govitecan

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2027-01-12
Completion
2028-08-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • Estonia
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609968 on ClinicalTrials.gov