AuthorisedTherapeutic exploratory (Phase II)Interventional

Hyperprogression upon cemiplimab alone or with chemotherapy in PD-L1 ≥ 50% NSCLC: a biomarker guided phase 2 trial – HYPERBOLIC study

This study, called HYPERBOLIC, is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) where a marker called PD-L1 is high. We are looking at a new medicine called cemiplimab (also known as Libtayo), which is an immunotherapy. Some patients will also receive standard chemotherapy drugs like cisplatin or carboplatin, along with paclitaxel or pemetrexed. The main purpose is to understand if cemiplimab, either alone or with chemotherapy, might cause the cancer to grow very quickly in some patients, a rare event called 'hyperprogression'. We will also look at how well the treatments work and what side effects they might cause. This helps doctors learn how to best use these medicines.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita' Vita-salute S. Raffaele

Enrolment target

700

Start

10 Feb 2026

non-small cell lung cancer (NSCLC)

What is this study about?

This study, named HYPERBOLIC, is designed for people who have a specific type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. For this study, patients must have a high level of a protein called PD-L1 in their cancer cells. This protein helps doctors decide if a certain type of treatment, like cemiplimab, might be helpful.

The study is looking at a medicine called cemiplimab (also known by its brand name, Libtayo). This is an immunotherapy, which means it helps your body's own immune system fight the cancer. Some patients in the study will receive cemiplimab on its own, while others will receive it along with standard chemotherapy drugs such as cisplatin, carboplatin, paclitaxel, or pemetrexed. This study is in an early stage (Phase II), meaning we are still gathering more information about the treatment.

One of the main things we want to understand is if these treatments, particularly cemiplimab, might sometimes cause the cancer to grow very quickly in some patients. This is a rare occurrence called 'hyperprogression.' We will carefully monitor how the cancer responds and also look at how effective the treatments are overall, and what side effects people might experience. By doing this, we hope to find safer and more effective ways to treat non-small cell lung cancer.

Key takeaways

This study is for advanced non-small cell lung cancer with high PD-L1.
It tests cemiplimab (Libtayo) with or without chemotherapy.
A key focus is on understanding if cancer can grow very quickly after starting treatment.
Researchers will also track how well the treatment works and its side effects.
Your cancer response will be monitored closely with scans and blood tests.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women.

Specifically, you need to have non-small cell lung cancer (NSCLC) that shows high levels of a protein called PD-L1. Your doctor will be able to check for this protein.

There might be other health conditions or previous treatments that could mean this study isn't right for you. Your doctor will go through all the details to see if you meet all the requirements.

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.

Am I 18 years old or older?
Do I have non-small cell lung cancer?
Has my doctor confirmed my cancer has high levels of PD-L1?
Am I able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive cemiplimab, which is given as a drip into a vein, either on its own or together with chemotherapy drugs. The specific chemotherapy you receive will depend on what your doctors think is best for you.

Throughout the study, you'll have regular hospital visits. These visits will include check-ups by the doctors, blood tests, and scans (like CT scans) to see how your cancer is responding and to monitor for any side effects. These scans will help us understand if the cancer is shrinking, staying the same, or growing. We will be paying close attention to how quickly your cancer might grow in the first few weeks.

The study will continue for as long as the treatment is helping and side effects are manageable. After you stop treatment, doctors will keep in touch to follow up on your health for a period of time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving new treatments that aren't widely available yet, which could help your cancer. However, there's no guarantee that the treatment will work for you, and like all medicines, cemiplimab and chemotherapy can cause side effects. These could range from mild to serious. The doctors will monitor you closely for any side effects and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
Italy

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for people with advanced forms of it.

What is cemiplimab (Libtayo)?

It's a type of immunotherapy that helps your body's immune system fight cancer cells.

What is 'hyperprogression'?

It's when a cancer grows very quickly shortly after starting a new treatment. This study is trying to understand if this happens with these drugs.

Will I get chemotherapy?

Some patients will get cemiplimab alone, others will get it with standard chemotherapy drugs like cisplatin or carboplatin.

How long will I be in the study?

Treatment will continue as long as it's helping and you're feeling well. You'll have follow-up visits afterwards.