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?

This trial explores the effectiveness of two treatments, Pumitamig and Pembrolizumab, for individuals with advanced Non-Small Cell Lung Cancer. It targets patients whose cancer cells exhibit a high level (50% or more) of PD-L1, a protein influencing the immune system's response to cancer. Participants must have a confirmed diagnosis of advanced lung cancer and should not have received any prior treatment for their advanced condition. This trial may suit those recently diagnosed and seeking a first treatment option. As a Phase 3 trial, it represents the final step before FDA approval, offering participants access to potentially groundbreaking treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Pumitamig has a manageable safety profile based on previous studies. Patients with advanced cancer, including lung cancer, have responded well to this treatment. Notably, Pumitamig is well-tolerated when combined with chemotherapy, with manageable safety concerns.

The FDA has already approved Pembrolizumab for treating various cancers, including non-small cell lung cancer, indicating its well-documented safety. While some side effects may occur, Pembrolizumab is generally considered safe for most people.

In summary, both treatments have established safety records. Pumitamig shows promise in ongoing research, and Pembrolizumab is already approved for similar conditions.12345

Why are researchers excited about this study treatment for Non-Small Cell Lung Cancer?

Pumitamig is unique because it offers a new approach to treating non-small cell lung cancer. Unlike most current treatments, which often focus on blocking proteins like PD-1 (as pembrolizumab does), Pumitamig targets a novel pathway that could potentially enhance the immune system's ability to fight cancer more effectively. Researchers are excited about Pumitamig because it could provide an alternative for patients who don't respond well to existing therapies or develop resistance over time. This new mechanism of action might lead to improved outcomes and broaden the options available for managing this challenging condition.

What evidence suggests that this trial's treatments could be effective for Non-Small Cell Lung Cancer?

This trial will compare Pumitamig and Pembrolizumab for treating advanced Non-Small Cell Lung Cancer (NSCLC). Research has shown that Pumitamig, which participants in this trial may receive, is promising. One study reported that 85% of patients on a low dose and 66.7% on a high dose experienced tumor shrinkage. The side effects were generally manageable, with serious side effects occurring in just over 40% of patients.

Pembrolizumab, another treatment option in this trial, is already a well-known treatment for NSCLC. Studies have shown it can help patients live longer and reduce tumor size, especially in those with high PD-L1 levels. Both treatments are effective, but Pembrolizumab has been successful for a longer time.12367

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pumitamig or Pembrolizumab as first-line treatment for advanced Non-Small Cell Lung Cancer

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Citations

BioNTech and Bristol Myers Squibb Present First Global ...

The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line ...

Study Details | NCT06712316 | Safety, Efficacy, and ...

The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains ...

WCLC 2025: Bispecific antibody dose shows promising ...

Among 38 evaluable patients, the overall response rate (ORR) was 85% and 66.7% with the low and high doses, respectively, with 89.5% of patients ...

Safety and Preliminary Effectiveness of BNT327, an ...

This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line ...

SABCS25: BioNTech, BMS flex upbeat interim mid-stage ...

Safety-wise, pumitamig's profile was manageable, with Grade ≥3 treatment-related adverse events reported in 42.5% and 38.2% of patients in ...

Safety, Preliminary Effectiveness of BNT327, an ...

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

Study Details | NCT06841055 | Safety and Preliminary ...

Study participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant ...