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Not yet recruitingPHASE2INTERVENTIONAL

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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. It involves combining commonly used chemotherapy (platinum-doublet chemotherapy) with one or two new drugs, called Imzokitug and Pumitamig. The main goal is to find out if adding these new drugs makes the treatment more effective and safe than current approaches. Participants will be split into different groups. One group will receive two new drugs (Imzokitug and Pumitamig) alongside chemotherapy. Another group will receive one new drug (Pumitamig) with chemotherapy. Researchers will carefully check for side effects and how well the treatments shrink the cancer and improve life for patients. This is a Phase 2 study, meaning it's still in the earlier stages of testing these new combinations.

At a glance

Status
Not yet recruiting
Phase
PHASE2
Sponsor
Bristol-Myers Squibb
Enrolment target
160
Start
15 Aug 2026
Estimated completion
15 Sep 2030

What is this study about?

This study is about finding better ways to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that has become advanced or has spread to other parts of the body. When lung cancer reaches this stage, it can be challenging to treat effectively. Doctors are always looking for new treatments that can help patients live longer and have a better quality of life.

In this study, researchers are testing two new anti-cancer drugs, Imzokitug and Pumitamig. These drugs work differently from traditional chemotherapy. We already know that standard chemotherapy, often called platinum-doublet chemotherapy, can help. This study wants to see if adding Imzokitug and/or Pumitamig to this standard chemotherapy makes the treatment even more effective and safe as a first treatment for advanced NSCLC.

Participants in the study will receive either both new drugs plus chemotherapy, or just one new drug (Pumitamig) plus chemotherapy. By comparing these groups, doctors hope to learn which combination works best, if it helps shrink the cancer more, and if it leads to fewer or manageable side effects. This research is important because it could lead to new treatment options for people with advanced lung cancer.

Key takeaways

  • Tests new drug combinations for advanced non-small cell lung cancer.
  • Compares two new drugs plus chemotherapy against one new drug plus chemotherapy.
  • Aims to find more effective and safer first-line treatments.
  • Involves regular hospital visits for treatment and health checks.
  • Is a Phase 2 study, meaning these combinations are still being evaluated.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to have non-small cell lung cancer that has been confirmed by a biopsy. It needs to be at an advanced stage (stage 4) or have come back after previous treatment and can't be removed by surgery. This would be your first medicine treatment for your advanced or widespread cancer. We would also need a tissue sample of your cancer from the last five months.

You would generally need to be fairly well and able to carry out daily activities with little difficulty. Your cancer must also be measurable, meaning doctors can see and track its size. We cannot include you if your cancer has certain specific genetic changes that can be treated with other approved medicines, if you've already had immunotherapy, or if you have untreated cancer spread to your brain.

There are a few other health factors that might mean you can't join the study, but the study team would go through all these details with you. Generally, participants need to be 18 years old or older, and the study is open to both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have advanced or spread non-small cell lung cancer?
  2. Is this my first medicine treatment for my advanced cancer?
  3. Am I generally well and able to do most daily activities?
  4. Have I had a recent tumor biopsy (within the last 5 months)?
  5. Have I NOT had immunotherapy before?
  6. Do I NOT have untreated cancer spread to my brain?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either a combination of two new drugs (Imzokitug and Pumitamig) plus chemotherapy, or one new drug (Pumitamig) plus chemotherapy. You won't get to choose which group you are in, as this is decided randomly, like flipping a coin. You will have regular visits to the hospital or clinic to receive your treatments and have various tests done, such as blood tests, scans (like CT scans), and physical exams. These tests help the doctors monitor your health, check how your body is reacting to the treatment, and see if the cancer is responding.

The specific number of visits and tests will depend on the treatment schedule and how you respond. You will be closely monitored for any side effects. Treatment will continue for as long as it is helping you and you are tolerating it well. After completing treatment, you will have follow-up appointments to track your long-term health. The total duration of your involvement could range from several months to a few years, depending on your treatment response and the follow-up plan.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments before they are widely available. While there's no guarantee that the treatment will help everyone, some people might find the new drug combinations more effective than standard treatments. However, like all medicines, the study drugs and chemotherapy can cause side effects. These can vary from mild to severe, and the study team will carefully monitor you and manage any side effects that arise. You will receive detailed information about all known and potential risks before you decide to join. It's very important to remember that participating in a clinical trial is always voluntary. You can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

  • Local Institution - 0170
    Verified postcode
    Athens, United States
  • Local Institution - 0034
    Verified postcode
    Lexington, United States
  • Local Institution - 0171
    Verified postcode
    Lexington, United States
  • Local Institution - 0123
    Verified postcode
    Baltimore, United States
  • Local Institution - 0102
    Verified postcode
    Omaha, United States
  • Local Institution - 0080
    Verified postcode
    New York, United States
  • Local Institution - 0105
    Verified postcode
    Nashville, United States
  • Local Institution - 0095
    Verified postcode
    Houston, United States
  • Local Institution - 0135
    Verified postcode
    Madison, United States
  • Local Institution - 0092
    Verified postcode
    Viedma, Argentina
  • Local Institution - 0082
    Verified postcode
    Rosario, Argentina
  • Local Institution - 0094
    Verified postcode
    Buenos Aires, Argentina

Common questions

What type of lung cancer is this study for?

This study is for advanced or spread non-small cell lung cancer (NSCLC), which has been confirmed by a biopsy.

Are the study drugs new?

Yes, Imzokitug and Pumitamig are new drugs being tested in combination with standard chemotherapy as a first treatment.

Will I know which treatment I'm getting?

No, you won't choose. You'll be randomly assigned to receive one of the treatment combinations as part of the study design.

What if I have side effects?

The study team will closely monitor you and provide care to help manage any side effects you experience.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your future medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study To Assess the Safety, Tolerability, and Efficacy of …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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