A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2029

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Cemiplimab

Cemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.

Trial Locations (34)

Unknown

Wien AKH, Vienna

North Estonia Medical Centre Foundation, Talinn

CHU d'Angers, Angers

Centre hospitalier d'Avignon, Avignon

Evangelische Lungenklinik Berlin, Buch

Ruhrlandklinik Essen, Essen

LMU München, München

Pius Hospital, University Medicine Oldenburg, Oldenburg

Beaumont Hospital, Dublin

St James's Hospital, Dublin

SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria

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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Instituto Europeo di Oncologia (IEO), Milan

AOU Maggiore della Carità, Novara

Instituto Oncologico Veneto IRCCS, Padua

Fondazione IRCCS Policlinico S. Matteo, Pavia

University of Perugia, AO SM Misericorida Perugia, Perugia

Azienda ospedaliero-universitaria Senese Siena, Siena

AULSS2 Marca Trevigiana Treviso, Treviso

Universita di Verona - Department of Medicine, Verona

National University Hospital, Singapore

Complejo Hospitalario Universitario, A Coruña

Hospital General Universitario Dr. Balmis de Alicante, Alicante

Hospital Universitario Cruces, Barakaldo

Hospital de La Santa Creu I Sant Pau, Barcelona

Hospital Universitario Vall D'Hebron, Barcelona

Hospital Clínico San Cecilio de Granada, Granada

Hospital Universitario de Jerez de La Frontera, Jerez de la Frontera

Hospital Clínico San Carlos, Madrid

Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

Hospital General Universitario de Valencia, Valencia

University Hospital Basel, Basel

Kantonsspital Winterthur, Winterthur

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK