New drug could keep lung cancer from coming back after surgery

NCT ID NCT06931717

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether the immunotherapy drug cemiplimab can prevent lung cancer from returning after surgery in patients with stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 levels of 1% or higher. About 390 participants will either receive cemiplimab or be observed without treatment. The main goal is to see if the drug improves disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cemiplimab (a drug that helps the immune system fight cancer)
What this could lead to: If it works, this could offer a new option to delay or prevent lung cancer recurrence after surgery without needing chemotherapy.
What could go wrong: This is still being tested—results are not yet known. The drug may cause immune-related side effects, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at screening prior randomisation. * Complete resection with negative surgical margins (R0). * Acceptable types of surgical resection include any of the following: * Lobectomy, sleeve lobectomy, bilobectomy, or pneumectomy. * Segmentectomy for tumours ≤2 cm is permitted in patients with poor pulmonary reserve or another major comorbidity that contraindicates lobectomy. * Wedge resection is not allowed. * Lymph node dissection should be done according to applicable guidelines. * No disease recurrence following surgical resection. * Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test. * Availability of archival FFPE tumour tissue for central PD-L1 expression testing. * Patient is not considered for adjuvant platinum-based chemotherapy due to: * Documented patient refusal; or * Patient is unfit to receive adjuvant platinum-based chemotherapy (per investigator assessment) due to: ECOG PS2, or ECOG PS 0/1 and aged ≥70 years with substantial comorbidities or other contraindication(s) to platinum-based doublet chemotherapy. * Estimated life expectancy of ≥3 months. * Age ≥18 years. * Patient has recovered from surgery-related complications. * Adequate haematological, renal and liver function. * Patient is able to comply with the trial protocol, in the investigator's judgment. * Negative pregnancy test Female participants of childbearing potential (including women who had their last menstruation in the last 2 years), must have a negative serum pregnancy test within 5 weeks before randomisation. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment and at every treatment visit (urine beta HCG test is sufficient). * Use of highly effective contraceptive methods Female participants of childbearing potential (including women who had their last menstruation in the last 2 years) and male participants with a female partners of childbearing potential must agree to use a highly effective method of contraception for the duration of the protocol treatment and until 4 months after the last dose of cemiplimab. * Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention. Exclusion Criteria: * EGFR-mutant or ALK-rearranged NSCLC. * Any small cell component * Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC. Note: Previous treatment for another malignancy not excluded as per next criterion (Participating in another interventional clinical trial for NSCLC) is allowed if the below conditions are fulfilled: * Treatment with an approved systemic therapy is completed \>4 weeks before randomisation or * Treatment with systemic biologic therapy is completed \>5 half-lives before randomisation and patient has recovered from any immune-mediated adverse events and endocrinopathies are adequately managed with hormone replacement. * Participating in another interventional clinical trial for NSCLC. * Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment. Exceptions: * Non-melanoma skin cancer that has undergone potentially curative therapy * In situ cervical carcinoma * Any tumour that has been deemed to be definitively treated, such as definitively treated non-metastatic prostate cancer. * Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to randomisation. Physiologic replacement doses are allowed even if they are \>10 mg of prednisone per day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder. Note: Patients who require a brief course of steroids (ex. 3 days in the week before randomisation) or physiologic replacement are allowed to be included in the study. * Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusions: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment. * Encephalitis, meningitis, organic brain disease (e.g., Parkinson's disease) or uncontrolled seizures within 1 year prior to randomisation. * Myocardial infarction within 6 months prior to randomisation. * Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation. * Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency. * Patients with known HIV infection who have controlled infection \[undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen\] are allowed to be included in the study. Patients with controlled HIV infection should be monitored according to local standards. * Patients with hepatitis B (HBsAg+) with controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) may be included in the study. Patients with controlled infection must undergo regular monitoring of HBV DNA. Patients must remain on antiviral therapy for at least 6 months after the last dose of cemiplimab. * Patients who are hepatitis C virus antibody positive (HCV Ab+) with controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be included in the study. * Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation. * Receipt of a live vaccine within 28 days before randomisation. * Receipt of a COVID-19 vaccination within 1 week before randomisation. * Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation. * Known or suspected hypersensitivity to cemiplimab or its excipients. * Women who are pregnant, planning to become pregnant or are in the period of lactation. * Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study. * Patients who are, or have an immediate family member who is, a member of the clinical study team, unless prior approval has been obtained from the sponsor (ETOP IBCSG Partners Foundation). * Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

35 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AOU Maggiore della Carità
NOT_YET_RECRUITING

Novara, Italy
AULSS2 Marca Trevigiana Treviso
NOT_YET_RECRUITING

Treviso, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
RECRUITING

Verona, Italy
Azienda ospedaliero-universitaria Senese Siena
NOT_YET_RECRUITING

Siena, Italy
Beaumont Hospital
RECRUITING

Dublin, Ireland
CHU d'Angers
NOT_YET_RECRUITING

Angers, France
Centre hospitalier d'Avignon
NOT_YET_RECRUITING

Avignon, France
Complejo Hospitalario Universitario
RECRUITING

A Coruña, Spain
Cork University Hospital
NOT_YET_RECRUITING

Cork, Ireland
Evangelische Lungenklinik Berlin
NOT_YET_RECRUITING

Buch, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITING

Milan, Italy
Fondazione IRCCS Policlinico S. Matteo
RECRUITING

Pavia, Italy
Hospital Clínico San Carlos
RECRUITING

Madrid, Spain
Hospital Clínico San Cecilio de Granada
RECRUITING

Granada, Spain
Hospital General Universitario Dr. Balmis de Alicante
RECRUITING

Alicante, Spain
Hospital General Universitario de Valencia
RECRUITING

Valencia, Spain
Hospital Universitario Cruces
RECRUITING

Barakaldo, Spain
Hospital Universitario Nuestra Señora de Candelaria
RECRUITING

Santa Cruz de Tenerife, Spain
Hospital Universitario Vall D'Hebron
RECRUITING

Barcelona, Spain
Hospital Universitario de Jerez de La Frontera
RECRUITING

Jerez de la Frontera, Spain
Hospital de La Santa Creu I Sant Pau
RECRUITING

Barcelona, Spain
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
RECRUITING

Meldola, Italy
Instituto Europeo di Oncologia (IEO)
RECRUITING

Milan, Italy
Kantonsspital Winterthur
RECRUITING

Winterthur, Switzerland
LMU München
RECRUITING

München, Germany
National University Hospital
RECRUITING

Singapore, Singapore
North Estonia Medical Centre Foundation
RECRUITING

Talinn, Estonia
Nuovo Ospedale di Prato Santo Stefano
RECRUITING

Prato, Italy
Pius Hospital, University Medicine Oldenburg
NOT_YET_RECRUITING

Oldenburg, Germany
Ruhrlandklinik Essen
RECRUITING

Essen, Germany
St James's Hospital
RECRUITING

Dublin, Ireland
St. Vincent's University Hospital
NOT_YET_RECRUITING

Dublin, Ireland
University Hospital Basel
RECRUITING

Basel, Switzerland
University of Perugia, AO SM Misericorida Perugia
NOT_YET_RECRUITING

Perugia, Italy
Wien AKH
NOT_YET_RECRUITING

Vienna, Austria

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