Pumitamig vs Pembrolizumab for Non-Small Cell Lung Cancer

Not yet recruiting at 249 trial locations
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with advanced Non-Small Cell Lung Cancer who haven't been treated before and have high levels of a protein called PD-L1 (≥ 50%). Specific eligibility details are not provided, but typically participants must be in good health aside from their cancer.

Inclusion Criteria

Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
My lung cancer is confirmed and is at an advanced stage.
My cancer has a PD-L1 expression of 50% or higher.
See 2 more

Exclusion Criteria

I don't have any genetic changes that can be treated with approved first-line therapies.
I do not have any untreated brain or spinal cord cancer spread.
Participants must not have an active autoimmune disease
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Pumitamig

Trial Overview

The study is testing the effectiveness of a new drug called Pumitamig against an established treatment, Pembrolizumab. Both drugs are given to see which works better for this type of lung cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: PumitamigExperimental Treatment1 Intervention
Group II: Arm B: PembrolizumabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

BioNTech SE

Industry Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University