Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

This study, called Morpheus-Lung, is a research trial exploring new treatment combinations for people with non-small cell lung cancer that has spread to other parts of the body (metastatic). Researchers are comparing several different drug combinations, including commonly used cancer medicines and newer ones. The main goal is to find out how effective these new combinations are at shrinking or controlling the cancer (this is called the 'objective response rate'). They also want to understand if these treatments are safe and what side effects they might cause. This is an early-stage study, meaning it's one of the first times these specific combinations are being tested in people to better understand their potential.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

149

Start

27 Jun 2024

Metastatic non-small cell lung cancer (NSCLC)

What is this study about?

This research study, known as Morpheus-Lung, is designed to investigate new ways to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC) when it has spread to other parts of the body. This is often referred to as advanced or metastatic lung cancer. The study is looking at several different treatment combinations, which include some common cancer medications like Avastin and Tecentriq, as well as some newer experimental drugs. The main purpose is to see how well these combinations work together to fight the cancer.

The study is divided into two main parts, Phase I and Phase II, which means it's an early-stage study. In these phases, doctors are carefully watching to see if the treatments are safe and what kinds of side effects might occur. They are also measuring how much the cancer shrinks or stops growing with these new combinations. This is a special type of study called an 'umbrella study' which means it tests several different treatment combinations at the same time under one main study. This can help researchers find out faster which combinations are most promising.

Finding new and more effective treatments for advanced lung cancer is very important. This study aims to contribute to our understanding of how different drugs can work together to improve patient outcomes. By carefully testing these combinations, researchers hope to identify better options for patients living with metastatic non-small cell lung cancer in the future.

Key takeaways

This study is testing new combinations of drugs for advanced lung cancer.
It's an early-stage study (Phase I/II) focused on safety and how well the treatments work.
Several different drugs, including both known and experimental ones, are being used.
The main goal is to find out if these new combinations can shrink or stabilize the cancer.
Participants will have regular clinic visits and tests to monitor their health.
It's important to discuss all aspects of the study with your doctor.

Who may be eligible?

To be able to join this study, participants generally need to be at least 18 years old. The study is open to both men and women.

Beyond age and sex, there will be other important health requirements. For example, your doctors will need to check your general health, your specific type of lung cancer, and how well your organs are working, like your kidneys and liver. These checks are put in place to ensure that taking part in the study is as safe as possible for you and that the results of the study are clear and accurate.

It's important to remember that not everyone with metastatic non-small cell lung cancer will be able to join. Your specialist doctor will review all your medical information carefully to see if you meet all the specific criteria. They will discuss this with you in detail if you are interested.

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.

Are you 18 years old or older?
Do you have non-small cell lung cancer that has spread?
Are you generally well enough to take part in a study?
Are you willing and able to attend regular appointments for tests and treatment?
Have you discussed your overall health and other conditions with the study doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the experimental treatment combinations. This would typically involve coming to the hospital or clinic for regular appointments. During these visits, you'd have various tests, such as blood tests, scans (like CT scans), and physical exams, to check how you're responding to the treatment and to monitor for any side effects.

The medications are given in different ways; some might be given through a drip into your arm (infusion), while others might be tablets you take by mouth. The exact schedule of visits and treatments would depend on which treatment combination you are assigned to. These visits could be frequent at first and then become less often over time.

After you finish the main treatment part of the study, doctors and nurses would continue to follow up with you to monitor your health and any long-term effects. The total length of your involvement in the study would vary depending on your individual response to the treatment, but studies like this often last for a number of months, or even years, including the follow-up period.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving new treatments before they are widely available and contributing to medical knowledge that could help future patients. However, there are also potential risks involved. The experimental treatments might not work for you, or they could cause side effects that range from mild to severe, some of which might be serious. Doctors will carefully monitor you for any side effects and provide care to manage them. It is very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain

Common questions

What is 'metastatic non-small cell lung cancer'?

This means your lung cancer started in your lung and has now spread to other parts of your body. 'Non-small cell' is the most common type of lung cancer.

What does a 'Phase I/II study' mean?

It means this is an early stage of testing. Phase I checks safety and dosage, and Phase II assesses if the treatment works and continues to check safety, often combining these steps.

What are the 'interventions' listed?

These are the medicines being tested in the study. Some are already used, and others are newer drugs or combinations being evaluated.

What is 'objective response rate (ORR)'?

This is a way for doctors to measure how much the cancer shrinks or disappears in response to the treatment being tested.

Will I know which treatment I'm getting?

This is an 'open-label' study, which means that both you and your study doctor will know which treatment you are receiving.