All studies
Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

This research is investigating a new treatment approach for non-small cell lung cancer that has spread to other parts of the body (metastatic NSCLC). The study combines two medicines, amivantamab and cetrelimab. In the first part, doctors will work to find the safest and most effective dose of these two drugs when given together. In the second part, they will observe how well this combination treatment shrinks tumors and controls the cancer in different groups of patients. These groups include people whose cancer has specific genetic changes (EGFR mutations) and those whose cancer shows high levels of a protein called PD-L1. The goal is to see if this new combination can offer a helpful option for people who have already tried other standard treatments for their lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Janssen Research & Development, LLC
Enrolment target
71
Start
18 May 2023
Estimated completion
31 Mar 2027

What is this study about?

This study is looking into a new way to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body. When cancer spreads, it's called metastatic. The study is testing two medicines together: a drug called amivantamab and another one called cetrelimab.

In the first part of the study, the main aim is to find the best and safest dose of these two medicines when given at the same time. This is important to make sure the treatment is as effective as possible while keeping side effects manageable. Once the best dose is found, the second part of the study will begin.

In the second part, doctors will look closely at how well this new combination treatment works in different groups of people. Some patients might have specific changes in their cancer cells, like problems with a gene called EGFR. Others might have cancer cells that show high levels of a protein called PD-L1. Understanding how the treatment works in these different groups will help doctors know who might benefit most from this new combination in the future.

Key takeaways

  • Tests a new combination of two drugs for advanced lung cancer.
  • Aims to find the best dose and see how well it works.
  • For people whose lung cancer has spread and who have tried other treatments.
  • Looks at specific genetic changes and protein levels in cancer cells.
  • Close monitoring by doctors for safety and effectiveness.

Who may be eligible?

To join this study, you need to have non-small cell lung cancer that has spread to other parts of your body. You should have already tried other standard treatments for your cancer, or not be able to have them. This includes chemotherapy and other targeted therapies, depending on your specific cancer type. If your cancer has certain genetic changes (like EGFR mutations), you would need to have progressed on other treatments meant for those changes.

Your cancer must show at least one area that can be measured by scans, and you should generally be well enough to take part, meaning you can carry out most everyday activities without much trouble.

There are also some reasons why you might not be able to join. For example, if you have other serious uncontrolled health problems like diabetes, an active infection, or a bleeding disorder. The doctors will check all of these things carefully to make sure the study is safe for you.

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 non-small cell lung cancer that has spread?
  2. Have I already tried standard treatments for my cancer?
  3. Do I have at least one cancer spot that can be measured on scans?
  4. Am I generally well enough to do most daily activities?
  5. Do I have any other serious health conditions that might prevent me from joining?
  6. Have my cancer cells been tested for specific genetic changes (like EGFR) or protein levels (PD-L1)?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the new combination of medications, amivantamab and cetrelimab. Initially, the study focuses on finding the right dose, so the exact dose you receive might vary until it's established. The research team will regularly monitor your health very closely with blood tests, scans, and physical examinations to see how you're responding to the treatment and to keep an eye on any side effects. You'll have regular hospital visits for these check-ups and to receive your medication. The total duration of your participation would depend on how well the treatment works for you and how you tolerate it, with ongoing follow-up after the treatment phase ends.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from a new treatment that isn't yet widely available, and your participation helps doctors learn more about cancer. However, new treatments can have side effects, which the study team will monitor closely. There's also no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (43)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • City of Hope
    Verified postcode
    Duarte, United States
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verified postcode
    Irvine, United States
  • Cancer and Blood Specialty Clinic
    Verified postcode
    Los Alamitos, United States
  • Providence Portland Medical Center
    Verified postcode
    Portland, United States
  • Providence Oncology and Hematology Care Clinic Westside
    Verified postcode
    Portland, United States
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Virginia Cancer Specialists
    Verified postcode
    Fairfax, United States
  • Fundacao Pio XII
    Verified postcode
    Barretos, Brazil
  • Cetus Oncologia
    Verified postcode
    Belo Horizonte, Brazil
  • PERSONAL Oncologia de Precisao e Personalizada
    Verified postcode
    Belo Horizonte, Brazil
  • CIONC Centro Integrado de Oncologia de Curitiba
    Verified postcode
    Curitiba, Brazil
  • Hospital do Cancer de Londrina
    Verified postcode
    Londrina, Brazil

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study focuses on it when it has spread to other parts of the body.

What are amivantamab and cetrelimab?

These are two different medicines being tested together. They work in different ways to fight cancer cells.

What does 'metastatic' mean?

It means the cancer has spread from where it started in the lung to other parts of your body.

What does 'Phase 1' and 'Phase 2' mean?

Phase 1 trials find the safest dose of a new treatment. Phase 2 trials then see how well that dose works.

Will I receive a placebo?

No, this study is testing two active drugs together. You will receive the study medications.

How to find out more

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

Discussion

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