Study of cemiplimab treatment after surgery in patients with stage II-IIIA non-small cell lung cancer who have not received chemotherapy and have PD-L1 expression of 1% or higher

3 1 1 1

What is this study about?

This study focuses on patients with non-small cell lung cancer (NSCLC) who have had their cancer surgically removed and are at stage II-IIIA of the disease. The study specifically looks at patients whose tumor cells show a certain protein marker called PD-L1. These patients have not received chemotherapy after their surgery.

The study will test a medication called cemiplimab (also known as LIBTAYO), which is given through an intravenous infusion. This medicine belongs to a group of drugs called immunotherapy, which helps the body’s immune system fight cancer cells. The purpose is to determine if giving cemiplimab after surgery can help prevent the cancer from returning, compared to patients who receive no additional treatment after surgery.

During the study, participants will either receive cemiplimab treatment or be observed without treatment. The medication will be given through an infusion into a vein every few weeks. The total treatment period may last up to 42 weeks. Doctors will monitor the participants’ health and check if the cancer returns during and after the treatment period.

1 Initial treatment preparation

Your participation begins after successful lung cancer surgery and confirmation of stage II-IIIA non-small cell lung cancer (NSCLC)

A test will confirm if your tumor has a specific protein marker called PD-L1 at a level of 1% or higher

Your tissue sample from surgery will be sent for additional testing to verify PD-L1 levels

2 Treatment assignment

You will be randomly assigned to one of two groups:

Group 1: Receiving cemiplimab treatment

Group 2: Observation without additional treatment

3 Treatment administration (if assigned to treatment group)

LIBTAYO (cemiplimab) 350 mg will be given through an intravenous infusion (directly into your vein)

The medication is first prepared as a solution from a concentrated form

Regular health assessments will monitor your response to treatment

4 Follow-up period

Regular check-ups will track your recovery and any signs of disease return

Your doctor will monitor for any side effects using a standardized rating system

The study will continue until December 2030

5 Health monitoring

Regular assessments of your overall health status

Tracking of any new health issues that may develop

Documentation of your recovery progress

Who Can Join the Study?

  • You must be at least 18 years old
  • You must have had surgery to remove stage II-IIIA non-small cell lung cancer with clean surgical margins (meaning all visible cancer was removed)
  • Your tumor must show a specific protein marker called PD-L1 at a level of 1% or higher
  • You must be fully recovered from any surgery-related complications
  • You must not be suitable for or have refused standard chemotherapy treatment with platinum-based drugs due to either:
    • Your own choice to refuse this treatment
    • Your doctor’s assessment that you are not fit for this treatment due to age (70 or older) or other health conditions
  • You must have a life expectancy of at least 3 months
  • Your major organs must be functioning properly
  • You must provide a tissue sample from your previous surgery for additional testing
  • You must provide written informed consent to participate
  • If you are a woman who can become pregnant, you must have a negative pregnancy test
  • Your cancer must not have returned after the surgery

Who Cannot Join the Study?

  • Prior treatment with any immunotherapy (medications that help your immune system fight cancer)
  • Active or untreated brain or spinal cord tumors
  • History of organ transplant
  • Active autoimmune disease (conditions where your immune system attacks your own body)
  • Ongoing infections requiring treatment
  • Previous cancer treatment within the last 3 years (except for certain skin cancers)
  • Known allergic reactions to similar medications
  • Uncontrolled heart, lung, liver, or kidney disease
  • Pregnancy or breastfeeding
  • Unable to undergo required medical tests and procedures
  • Current participation in other clinical trials
  • Use of systemic steroids (pills or injections that affect your whole body) or other medications that suppress the immune system
  • Serious medical conditions that could interfere with study participation
  • History of certain lung diseases that could affect study results

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Centre Hospitalier D Avignon Avignon France
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Universitario De Cruces Barakaldo Spain
Hospital General Universitario De Valencia Valencia Spain
Azienda USL Toscana Centro Prato Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
North Estonia Medical Centre Foundation Tallin Estonia
Beaumont Hospital Dublin Ireland
Hfmkshjx Vjtc dejyeukc Barcelona Spain
Iwutznhe Rtyagojcx Pow Lw Sclxfz Din Tomqpd Dvgy Ajgwkac Iaac Slhdtg Meldola Italy
Apsgdbf Obvushnlljm Ufywedmfjwhwp Svpujg Siena Italy
Kldgxazi dsm Usypyjdmoxhp Mlbyezyj Ahv Munich Germany
Hwxoxcfk Dt Lr Sgflr Cipd I Slon Pek Barcelona Spain
Si Vbhmwatdkhwhrar Uncrzgnibl Hhiapzqi Dublin Ireland
Cmgy Umxntawspi Hmrgwvcc Cork Ireland
Cmxjyd Hlysblsjskt Rtirmcvi Dazbpkfopnugug Angers France
Hojgqens Udpnotpgzbvik dk A Cfaalg A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.09.2025
Estonia Estonia
Recruiting
01.09.2025
France France
Not yet recruiting
01.09.2025
Germany Germany
Not yet recruiting
01.09.2025
Ireland Ireland
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Cemiplimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It belongs to a group of drugs called PD-1 inhibitors. This medication works by blocking certain proteins that cancer cells use to hide from your immune system, allowing your body’s natural defenses to better recognize and attack the cancer cells. It is used after surgery in patients with non-small cell lung cancer to help prevent the cancer from returning.

Non-small cell lung cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. It typically develops slowly and forms solid tumors in the lung tissue. The disease can progress through different stages, from stage I where cancer is localized, to stage IIIA where it has spread to nearby lymph nodes. NSCLC accounts for the majority of all lung cancer cases and can affect various parts of the lungs. The condition involves abnormal cell growth that can spread from its original location to surrounding tissues.

Trial ID:
2024-519901-36-00
Protocol code:
ETOP 27-23 ARCH
NCT ID:
NCT06931717
Trial Phase:
Therapeutic confirmatory (Phase III)

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