160 Participants NeededMy employer runs this trial

Imzokitug + Pumitamig for Lung Cancer

Recruiting at 73 trial locations
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Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 a new combination of treatments to evaluate their safety and effectiveness for people with advanced lung cancer. Participants will receive either a mix of Imzokitug (a potential new drug), Pumitamig (another potential new drug), and standard chemotherapy, or just Pumitamig with chemotherapy. The goal is to determine which option works better as a first treatment for non-small cell lung cancer that has spread or cannot be removed by surgery. Suitable candidates include those with a confirmed diagnosis of advanced non-small cell lung cancer who have not received previous treatment for their advanced cancer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in lung cancer treatment.

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

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?

A study found that Imzokitug, when combined with other treatments, had a manageable safety profile for patients with advanced lung cancer. While side effects occurred, they were not severe. Research also shows that most patients tolerated Imzokitug well.

For Pumitamig, studies suggest it also had a manageable safety profile. No new safety concerns emerged, and few patients discontinued treatment due to side effects.

Both treatments have been deemed safe enough for further testing and are generally well-tolerated by most patients. However, like any treatment, side effects can occur, so discussing any concerns with a doctor is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Imzokitug and Pumitamig for treating lung cancer because these drugs offer a fresh approach compared to traditional treatments like chemotherapy and targeted therapies. Imzokitug is unique due to its novel mechanism of action, which specifically targets and inhibits pathways critical for cancer cell survival, potentially leading to more effective tumor reduction. Pumitamig stands out for its ability to boost the immune system's response against cancer cells, which could enhance the body's natural ability to fight the disease. Together, these treatments could offer a powerful combination that not only targets cancer cells directly but also strengthens the body's defenses, offering new hope for improved outcomes in lung cancer treatment.

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

This trial will evaluate the effectiveness of Imzokitug and Pumitamig for treating non-small cell lung cancer (NSCLC) in separate treatment arms. Studies have shown promising results for both Imzokitug and Pumitamig individually. Specifically, research indicates that combining Pumitamig with chemotherapy helped up to 70% of patients with advanced NSCLC respond to treatment and kept the disease under control in all evaluable patients. Imzokitug, on the other hand, has improved patient outcomes, particularly by increasing survival rates. These findings suggest that using Imzokitug and Pumitamig, whether separately or together, could effectively treat NSCLC by enhancing patient response to treatment and controlling disease progression.678910

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 locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior treatment for their advanced disease. Participants should be healthy enough to receive chemotherapy and meet other medical requirements set by the study.

Inclusion Criteria

I have not received systemic therapy for advanced or metastatic cancer.
Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site
I have stage IV or recurrent, inoperable non-small cell lung cancer.
See 2 more

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply
My cancer does not have gene changes treatable with approved targeted drugs.
I have not received any immunotherapy treatments for my cancer.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) or Pumitamig and PDCT alone as first-line treatment for NSCLC

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Imzokitug
  • Pumitamig

Trial Overview

The study compares two treatments: one group gets Imzokitug plus Pumitamig and standard platinum-doublet chemotherapy, while the other group receives only Pumitamig with the same chemotherapy. The goal is to see if adding Imzokitug improves outcomes.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Arm D: Pumitamig + Histology-based PDCTExperimental Treatment7 Interventions
Group II: Arm C: Pumitamig + Imzokitug + Histology-based PDCTExperimental Treatment8 Interventions
Group III: Arm B: Pumitamig + Imzokitug + Histology-based PDCTExperimental Treatment8 Interventions
Group IV: Arm A: Pumitamig + Imzokitug + Histology-based PDCTExperimental Treatment8 Interventions

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

Citations

Real-World Outcomes and Clinical Predictors of Immune ...

Treatment outcomes included objective response rate, progression-free survival (PFS), and overall survival (OS). with a 5-year survival rate of around 19%.1

Treatment Options for Advanced Non-Small Cell Lung ...

We conducted analyses of the outcomes, costs, and cost-effectiveness of treatment for advanced. NSCLC for two distinct populations: 1. First-line treatment ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30591549/

Real-World Outcomes of Patients with Metastatic Non ...

Estimated median overall survival (OS) was 8.0 months (95% confidence interval 7.4-9.0 months). Estimated median OS was 4.7 months

Small Cell Lung Cancer — Competitive Landscape

~15–20% of all lung cancers, ~30,000 new US cases annually, and a 5-year overall survival rate below 7% in extensive-stage disease.

'Targeting' Improved Outcomes with Antibody-Drug ...

In this comprehensive review, we will be discussing the recent evidence including targets, efficacy and the safety of newer ADC candidates in NSCLC.

NCT07680764 | A Study To Assess the Safety, Tolerability, ...

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug. With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 1/2 study of Imzokitug plus Pumitamig and ...

A clinical trial testing whether adding a new medicine (Imzokitug) is safe enough for patients newly diagnosed with advanced or metastatic lung cancer

A Study To Assess the Safety, Tolerability, and Efficacy of ...

This research study is looking at new ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced.

Efficacy and safety of immune checkpoint inhibitors in non ...

This meta-analysis provides clinical evidence that ICIs improve PFS, OS, and ORR in NSCLC with fewer adverse effects.

Lung Cancer Clinical Trials | BMS Study Connect

Non-small cell lung cancer (NSCLC) accounts for about 85–90% of Lung Cancer diagnoses, Safety, Tolerability, and Efficacy of Imzokitug