AuthorisedTherapeutic exploratory (Phase II)Interventional

A multicenter open-label phase II study of Cemiplimab plus chemotherapy, selected on the basis of baseline cytidine deaminase activity, in advanced squamous non-small cell lung cancer - CECYDE trial - GOIRC-04-2024

This phase II clinical trial explores a new treatment option for people with advanced squamous non-small cell lung cancer. Participants will receive an immunotherapy drug called cemiplimab alongside standard chemotherapy. Immunotherapy works by helping your body's natural immune system recognise and attack cancer cells. Chemotherapy works by directly destroying rapidly dividing cells. In this trial, doctors will also check your baseline level of a natural enzyme called cytidine deaminase (CDA). This protein plays a role in how the body processes chemotherapy. Researchers want to see if checking CDA levels helps predict who benefits most, particularly focusing on patients with lower CDA activity. The main goal of the study is to see if this drug combination improves one-year survival rates and keeps the cancer from growing, while carefully tracking patient safety and side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica

Enrolment target

108

Start

03 Jul 2026

Advanced squamous non-small cell lung cancer

What is this study about?

Squamous non-small cell lung cancer is a common form of lung cancer that begins in the cells lining the airways. When the cancer is described as advanced, it means it has spread to nearby tissue or other parts of the body. In these situations, surgery alone is usually not possible, and doctors look to drug treatments to control the disease, relieve symptoms, and help people live longer.

In recent years, immunotherapy has changed how doctors treat lung cancer. Drugs like cemiplimab help take the 'brakes' off your immune system so your own white blood cells can find and fight cancer cells. In this study, called the CECYDE trial, researchers are combining cemiplimab with standard chemotherapy to find out whether using both treatments together works better than chemotherapy alone.

A key part of this trial is looking at a natural protein in the body called cytidine deaminase (CDA). This enzyme is involved in breaking down certain medicines, including some chemotherapy drugs. Doctors want to understand whether testing a person's CDA levels before treatment can help predict how well the combination will work. By focusing on patients with lower CDA activity, researchers hope to see if this tailored approach leads to better outcomes.

By following participants over months and years, the trial team aims to measure how long the treatment keeps tumours stable and whether it extends overall life expectancy. The results could help doctors personalise future lung cancer care, ensuring patients receive the treatments best suited to their individual biology.

Key takeaways

Tests the combination of cemiplimab (immunotherapy) and standard chemotherapy.
Designed for adults with advanced squamous non-small cell lung cancer.
Uses a blood test to check CDA enzyme levels to help guide and understand treatment results.
Aims to find out if the combination improves survival and tumour control.
Participation is entirely voluntary, with close monitoring throughout.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with advanced squamous non-small cell lung cancer. Both men and women can take part.

To be considered, your cancer must be confirmed as squamous non-small cell lung cancer, and it must be at an advanced stage. You will also have tests to check your overall fitness and organ health to ensure that receiving chemotherapy and immunotherapy is safe for you.

You may not be eligible if you have certain other serious medical conditions, such as severe auto-immune diseases or active infections, or if your general health makes travelling to appointments and receiving strong cancer treatments unsuitable. Your cancer doctor will review your full medical history to confirm whether you qualify.

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.

I am aged 18 or older.
I have been diagnosed with advanced squamous non-small cell lung cancer.
I am well enough to attend regular hospital appointments for treatment.
I am willing to have blood tests and regular imaging scans.
I am happy to discuss my full medical history with the research team.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will receive the immunotherapy drug cemiplimab alongside standard chemotherapy. Both medicines are usually given as an infusion through a small tube into a vein (a drip) in the hospital day unit. You will visit the clinic regularly for treatment cycles and check-ups.

Before you start, you will have blood tests (including tests to measure your CDA enzyme level) and imaging scans, such as CT or PET scans, to measure the size of your tumour. During the study, you will have regular blood tests and repeat scans every few weeks or months to see how well the cancer is responding.

Treatment will continue for as long as the medication helps control your cancer and the side effects are manageable. After active treatment ends, the research team will continue to check on your health and wellbeing through regular follow-up visits or phone calls for up to five years.

Potential risks and benefits

The main hope of taking part is that combining cemiplimab with chemotherapy may shrink your tumour, slow down the cancer, or help you live longer, though these benefits cannot be guaranteed. You will also receive very close health monitoring from a specialist cancer team. However, there are risks of side effects. Chemotherapy can cause nausea, tiredness, hair loss, and an increased risk of infection. Immunotherapy can cause your immune system to attack healthy parts of your body, leading to inflammation in organs such as the lungs, bowels, or liver. Your medical team will watch you closely and treat any problems quickly. Joining the trial is entirely your choice, and you can withdraw at any time without your normal NHS care being affected.

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 cemiplimab?

Cemiplimab is an immunotherapy medicine that helps your body's immune system recognise and attack cancer cells.

What does an 'open-label' study mean?

Open-label means both you and your doctors will know exactly which treatments you are receiving. There are no dummy treatments or placebos used in this trial.

Why is cytidine deaminase (CDA) important?

CDA is a natural enzyme that breaks down certain chemotherapy drugs. Researchers want to see if testing CDA levels helps predict which patients get the best results from treatment.

Will I still receive standard cancer treatment?

Yes. The trial combines the study drug cemiplimab with standard chemotherapy that is commonly used to treat this type of lung cancer.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can leave the trial at any time, for any reason, and your regular medical team will continue to support you with standard care.