AuthorisedTherapeutic exploratory (Phase II)Interventional

METAREM / META-1 - METAREM : Adaptive Master Trial for Advanced Cancers with Rapid Evaluation of Molecular & Immune Status for Stratified Immunotherapies in Oncology / META-1 : Anti-PD1 monotherapy in 1L advanced NSCLC patients with PDL1 TPS > 50% and PTI=0

This research is a two-part study called METAREM and META-1, focusing on advanced cancers that have spread or can't be removed. META-1 specifically investigates a type of advanced lung cancer (non-small cell lung cancer, or NSCLC) where particular markers are high, but others are absent. The study is testing two different cancer drugs, Keytruda and Libtayo, to see how well they work. Researchers want to find out if these drugs can stop the cancer from getting worse within 12 weeks. They will also look at how patients feel, their quality of life, and any side effects. This is a Phase II study, meaning it's exploring new treatments.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Unicancer

Enrolment target

Start

16 Apr 2026

METAREM:Patients with advanced cancer, as defined as unresectable locally advanced malignancies or metastatic cancers (including leukemias and lymphomas).

What is this study about?

This research programme, made up of two parts called METAREM and META-1, is designed to find better ways to treat advanced cancers. Advanced cancer means the cancer has spread from where it started or can't be fully removed by surgery. The METAREM part acts like a bigger framework, looking at different ways to match treatments to patients based on specific features of their cancer.

The META-1 part of the study is specifically focusing on a type of advanced lung cancer called non-small cell lung cancer (NSCLC). For patients in this part, their cancer must have a high level of a certain marker called PD-L1 (over 50%) and not have certain other genetic changes (EGFR, ALK, ROS1 mutations). In this study, we are testing two medicines, Keytruda and Libtayo. These are types of immunotherapy, which work by helping your body's own immune system fight the cancer. We want to see if these medicines can stop the cancer from growing for at least 12 weeks.

Beyond simply stopping cancer growth, the researchers are also very interested in how these treatments affect your daily life. They will look at whether the tumours shrink, how long people live, and if the cancer stays away for a longer period. Importantly, they will also closely monitor any side effects you might experience and how the treatment impacts your overall quality of life. This helps us understand not just if the treatment works, but how well people feel while receiving it.

Key takeaways

Targets advanced cancers, including a specific type of lung cancer (NSCLC).
Tests new immunotherapy drugs: Keytruda and Libtayo.
Aims to see if the drugs stop cancer growth for at least 12 weeks.
Will closely monitor side effects and patient quality of life.
Participation involves regular hospital visits for treatment and assessments.
You can stop participating at any time.

Who may be eligible?

To join the main METAREM study, you would need to have an advanced cancer. This means your cancer has spread or doctors cannot remove it with surgery. This includes certain blood cancers like leukaemia and lymphoma.

For the META-1 part of the study, which focuses on lung cancer, there are some specific requirements. You would need to be starting your first treatment for advanced non-small cell lung cancer, and your cancer must show a high level of a specific marker called PD-L1 (over 50%). Also, your cancer shouldn't have certain other genetic changes that doctors usually check for.

All participants must be at least 18 years old. Both men and women can take part in this study.

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 advanced cancer that has spread or can't be removed?
If you have lung cancer, is it non-small cell lung cancer (NSCLC)?
Have your doctors confirmed that your lung cancer has high PD-L1 (over 50%) but not certain other genetic changes (EGFR/ALK/ROS1 mutations)?
Are you currently starting your very first treatment for this advanced lung cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the study medications, Keytruda or Libtayo, which are given through a drip into your arm. These treatments are typically given regularly, usually over several weeks or months, depending on how your body responds. You would have regular visits to the hospital for these infusions and for various tests.

These tests will include blood tests, body scans to check on your cancer, and questionnaires to understand how you are feeling and your quality of life. You'll fill out surveys regularly to report any side effects you experience. Your doctor and the study team will monitor you closely throughout the treatment period. The overall duration of your participation will depend on how you respond to the treatment and the study's follow-up plan, but it will involve weekly check-ins for side effects initially, and regular hospital visits for treatment and assessments.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving new treatments that aren't widely available yet, which could help slow down or shrink your cancer. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious. The study team will carefully monitor you for any side effects and manage them as best as possible. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What kind of cancer is this study for?

The general study is for advanced cancers that have spread or can't be removed. One part specifically focuses on a type of advanced lung cancer called non-small cell lung cancer (NSCLC).

What medicines are being tested?

The study is testing two medicines called Keytruda and Libtayo, which are types of immunotherapy that help your body's immune system fight cancer.

What are the doctors hoping to find out?

They want to see if the medicines can stop cancer from growing for at least 12 weeks, how they affect your quality of life, and what side effects they might cause.

Do I have to do anything special to join?

You need to be over 18. For the lung cancer part, your cancer needs to have specific markers and not others, which your doctor can test for.

What does a 'Phase II' study mean?

A Phase II study means researchers are exploring if a new treatment works and is safe for a particular condition, after it has been shown to be safe in smaller studies.