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A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

NCT06472076 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-09-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Conditions

  • Lung Cancer, Non-Small Cell

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

BIOLOGICAL

Belrestotug

Belrestotug will be administered.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered.

DRUG

Placebo

Placebo will be administered.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2027-02-02
Completion
2027-02-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Finland
  • France
  • Germany
  • Hong Kong
  • India
  • Japan
  • Mexico
  • Netherlands
  • Panama
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)

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 NCT06472076 on ClinicalTrials.gov