Active not recruitingPHASE3INTERVENTIONAL

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

This study, called NEPTUNE, is testing a new combination of two medicines, durvalumab and tremelimumab, for people with advanced non-small cell lung cancer that has spread. This is for people who haven't had treatment for their advanced cancer before. The new drug combination will be compared to standard chemotherapy treatments. Doctors want to find out if the new drugs are better at helping people live longer and how safe they are. Participants will be chosen by chance to receive either the new drugs or standard chemotherapy. It's a global study, meaning many hospitals around the world are taking part.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

953

Start

03 Nov 2015

Estimated completion

31 Dec 2026

Non Small Cell Lung Carcinoma NSCLC

What is this study about?

This study is called NEPTUNE, and it's looking into new ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has spread to other parts of their body (which doctors call 'metastatic') and who are getting treatment for the first time for their advanced cancer. The main goal is to see if a combination of two new medicines, durvalumab and tremelimumab, works better and is safer than the usual chemotherapy treatments.

At the moment, chemotherapy is a standard first treatment for this kind of cancer. But researchers are always looking for new and improved options. Durvalumab and tremelimumab are types of medicines that work with your body's immune system to fight cancer. They aim to boost your natural defences to attack the cancer cells. This study is important because it could lead to new treatment choices for people with advanced lung cancer.

By comparing the new drug combination with standard chemotherapy, the researchers hope to understand which approach gives patients the best chance. They'll be carefully watching how long people live and whether the treatments cause any serious side effects. This kind of research helps doctors make better decisions about how to treat lung cancer in the future.

Key takeaways

This study is for people with advanced non-small cell lung cancer.
It tests new immune therapies against standard chemotherapy.
Participants will be randomly assigned to one of two treatment groups.
The main aim is to see which treatment helps people live longer and is safer.
It's a 'first-line' treatment study, meaning it's for people having their initial treatment for advanced cancer.

Who may be eligible?

To be able to join this study, you would need to be at least 18 years old and have advanced non-small cell lung cancer that has spread. Importantly, your cancer shouldn't have specific genetic changes called EGFR mutations or ALK rearrangements. You also must not have received any previous treatment for your advanced lung cancer; this would be your very first treatment.

There are also some health conditions that would mean you couldn't join. For example, if you have certain severe autoimmune conditions (where your immune system mistakenly attacks your own body) like Crohn's disease, or if you've had certain types of previous immune treatments. If your cancer is a mix of non-small cell and small cell lung cancer, or if you have certain brain tumours that are causing symptoms or need steroid treatment, you wouldn't be able to take part.

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 at least 18 years old?
Do you have advanced non-small cell lung cancer that has spread?
Have you *not* had any previous treatment for your advanced lung cancer?
Does your cancer *not* have specific genetic changes called EGFR or ALK?
Are you generally well enough to do most day-to-day activities?
Do you *not* have certain serious autoimmune diseases or unmanaged brain tumours?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly chosen to receive either the new drug combination (durvalumab + tremelimumab) or one of the standard chemotherapy treatments. This means you wouldn't get to choose which treatment you receive. You would have regular visits to the hospital for your treatment, checks, and tests, which would include blood tests and scans, to see how you are responding to the treatment and to monitor for any side effects. These visits and tests are crucial for the researchers to understand how the treatments are working. The total time you spend in the study would depend on how your treatment is progressing, but it typically involves treatments over several months, followed by regular check-ups.

Potential risks and benefits

Taking part in this study could offer you access to new treatments before they are widely available. While there's no guarantee, the new drugs might be more effective than standard treatment. However, like all medicines, both the new drugs and standard chemotherapy can have side effects, which could be serious. The researchers will closely monitor you for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (210)

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

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Anaheim, United States
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San Diego, United States
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Santa Rosa, United States
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Louisville, United States
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Florham Park, United States
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Albuquerque, United States
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East Setauket, United States
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Fresh Meadows, United States
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Poughkeepsie, United States
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Stony Brook, United States
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Canton, United States
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Columbus, United States

Common questions

What is non-small cell lung cancer (NSCLC)?

NSCLC is the most common type of lung cancer. 'Metastatic' means the cancer has spread from where it started to other parts of the body.

What are durvalumab and tremelimumab?

These are new immune therapies, which are medicines that help your body's own immune system fight cancer cells more effectively.

What does 'randomised' mean?

It means you will be chosen purely by chance, like flipping a coin, to receive either the new drug combination or standard chemotherapy. Neither you nor your doctor can choose.

Do I have to pay to be in the study?

No, all treatments, tests, and care related to the study are provided free of charge.

What if my condition changes during the study?

Your health will be closely monitored. If your condition changes or if the treatment is not suitable, the study doctors will discuss the best next steps for your care.