Pumitamig vs Durvalumab for Lung Cancer

Not yet recruiting at 247 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Pumitamig (a new potential drug) and Durvalumab, to determine which is more effective for individuals with Non-small Cell Lung Cancer (NSCLC) that cannot be surgically removed. It targets those who have already undergone a combination of chemotherapy and radiation without cancer progression. Suitable candidates have confirmed NSCLC, have completed at least two cycles of specific chemotherapy and radiation, and have not experienced cancer progression after this treatment. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if 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, when combined with chemotherapy, generally has a manageable safety profile for patients. Side effects are usually mild and align with expectations from past studies. No new safety concerns emerged, and few patients discontinued treatment early due to side effects. Although serious side effects occurred, they were uncommon, indicating that the treatment is generally well-tolerated.

Durvalumab has already received FDA approval for certain types of lung cancer, confirming its safety through thorough human testing. While it can cause side effects, these are typically known and manageable with medical care.

Both Pumitamig and Durvalumab have demonstrated safety in treating conditions like lung cancer, though monitoring for side effects during treatment remains important.12345

Why do researchers think this study treatment might be promising?

Pumitamig is unique because it targets lung cancer cells differently from the current standard treatments like chemotherapy and immunotherapy. Most treatments for lung cancer work by either killing fast-growing cells or boosting the immune system to attack cancer cells. But Pumitamig introduces a novel mechanism by specifically targeting certain proteins involved in cancer cell growth, offering the potential for more precise and effective treatment. Researchers are excited about Pumitamig because it could lead to fewer side effects and improve outcomes for patients who might not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for lung cancer?

This trial will compare Pumitamig with Durvalumab for lung cancer. Research has shown that Pumitamig, a special type of antibody, produces promising results in fighting cancer. In earlier studies with patients who have small cell lung cancer, Pumitamig slowed the cancer and helped patients live longer without progression. This suggests it might also be effective for non-small cell lung cancer. The treatment targets two pathways that aid cancer growth, potentially increasing its effectiveness. While more research is needed, these findings offer a positive sign for those considering this treatment option.15678

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 Stage III Non-small Cell Lung Cancer that can't be removed by surgery. They must have finished at least two rounds of platinum-based chemo and radiation without their cancer getting worse, and be in good physical shape (able to perform daily activities). People with autoimmune diseases, certain gene mutations, serious lung or heart conditions, or those who've had other recent cancer treatments can't join.

Inclusion Criteria

My lung cancer is confirmed and cannot be removed by surgery.
I have completed at least 2 cycles of chemotherapy with platinum and received radiation of 54 Gy or more.
My cancer did not worsen after chemoradiotherapy.
See 1 more

Exclusion Criteria

Participants must not have an active autoimmune disease
My non-squamous cancer does not have EGFR or ALK changes.
I don't have serious lung problems or a history of lung disease needing steroids.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Concurrent Chemoradiation Therapy

Participants receive platinum-based concurrent chemoradiation therapy

6-8 weeks

Treatment

Participants receive either Pumitamig or Durvalumab

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Pumitamig

Trial Overview

The study compares Pumitamig and Durvalumab as follow-up treatments after patients have already received chemoradiation therapy. The goal is to see which drug works better at keeping the cancer from advancing further in people whose tumors couldn’t be surgically removed.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BActive 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

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NCT07361510 | A Study to Evaluate the Efficacy of ...

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung ...

Bispecific antibody trial shows encouraging antitumour ...

The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer (Cohort 1) who received pumitamig in combination ...

Pumitamig Shows Positive Trend in PFS Treating Patients ...

Interim trial data presented at the 2025 World Conference on Lung Cancer shows pumitamig's promising efficacy in patients with extensive ...

Q2 2025 BNTX Presentation - BioNTech

Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1. 63. 1. Globocan – Cancer Tomorrow. 2. CancerMPact® 2024 ...

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

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).

BioNTech and BMS' bispecific touts 59.3% nine-month PFS ...

Alongside its promising efficacy, pumitamig plus chemotherapy was fairly well tolerated, with severe treatment-emergent adverse events (TEAEs) ...

Global Phase 2 Randomized Trial of BNT327 (Pumitamig; ...

... Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity. "The data are being presented ...