Clinical trial • Phase III • Oncology|Respiratory

CEMIPLIMAB for Non-small cell lung cancer (resected)|Stage II–IIIA non-small cell lung cancer|PD-L1-positive non-small cell lung cancer

Phase III trial of CEMIPLIMAB for Non-small cell lung cancer (resected)|Stage II–IIIA non-small cell lung cancer|PD-L1-positive non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Non-small cell lung cancer (resected)|Stage II–IIIA non-small cell lung cancer|PD-L1-positive non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-06-2025
First CTIS Authorization Date
08-10-2025

Trial design

Randomised, open-label, control arm: observation (no adjuvant treatment). experimental arm: 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. Phase III trial across 32 sites in Estonia, Germany, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: Observation (no adjuvant treatment). Experimental arm: 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.
Biomarker Stratified
True, PD-L1 (central) ≥1%
Target Sample Size
300
Trial Duration For Participant
365

Eligibility

Recruits 300 Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent is required before any trial-related intervention. Subject information and informed consent form documents (L1_SIS and ICF Master and country/language-specific ICFs) are provided (multiple language versions listed in the trial documents)..

Pregnancy Exclusion
Negative pregnancy test for female participants of childbearing potential
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Written informed consent is required before any trial-related intervention. Subject information and informed consent form documents (L1_SIS and ICF Master and country/language-specific ICFs) are provided (multiple language versions listed in the trial documents).

Inclusion criteria

  • {"criterion_text":"- Resected pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC with negative surgical margins (R0). No disease recurrence following surgical resection.\n- Written Informed Consent before any trial-related intervention\n- Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.\n- Availability of archival FFPE tumour tissue for central PD-L1 expression testing.\n- Patient is not considered for adjuvant platinum-based chemotherapy due to a. Documented patient refusal; or b. 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\n- Estimated life expectancy of ≥3 months\n- Age ≥18 years\n- Patient has recovered from surgery-related complications\n- Adequate organ function\n- Negative pregnancy test for female participants of childbearing potential"}

Exclusion criteria

  • {"criterion_text":"- EGFR-mutant or ALK-rearranged NSCLC.\n- Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation.\n- Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency.\n- Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation.\n- Receipt of a live vaccine within 28 days before randomisation.\n- Receipt of a COVID-19 vaccination within 1 week before randomisation.\n- Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation.\n- Known or suspected hypersensitivity to cemiplimab or its excipients.\n- Any small cell component.\n- Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC.\n- Participating in another interventional clinical trial for NSCLC.\n- Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment.\n- Any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to randomisation.\n- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.\n- Encephalitis, meningitis, organic brain disease (e.g., Parkinson’s disease) or uncontrolled seizures within 1 year prior to randomisation.\n- Myocardial infarction within 6 months prior to randomisation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%)","definition_or_measurement_approach":"Measured as disease-free survival; the primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression ≥1%."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Measured as overall survival (time-to-event)."}
  • {"endpoint_text":"- Incidence, nature and severity of adverse events according to CTCAE v5","definition_or_measurement_approach":"Adverse events assessed and graded according to CTCAE v5."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
63
Consent Approach
Written informed consent by the participant is required before any trial-related intervention. ICF and subject information materials (L1_SIS and ICF Master and multiple language/country-specific ICFs) are provided; language versions include (documents listed) German, French, Italian, Spanish, Estonian, Russian and English country-specific ICFs and patient information materials.

Geography

Total Number Of Sites
32
Total Number Of Participants
300

Estonia

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
20
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
North Estonia Medical Centre Foundation
Department Name
chemotherapy
Principal Investigator Name
Kersti Oselin
Principal Investigator Email
info@regionaalhaigla.ee
Contact Person Name
Kersti Oselin
Contact Person Email
info@regionaalhaigla.ee

Germany

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
22
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Department of Thoracic Surgery and Thoracic Endoscopy
Principal Investigator Name
Servet Bölükbas
Principal Investigator Email
servet.boeluekbas@rlk.uk-essen.de
Contact Person Name
Servet Bölükbas
Site Name
Pius-Hospital Oldenburg
Department Name
Medical Oncology
Principal Investigator Name
Frank Griesinger
Principal Investigator Email
frank.griesinger@pius-hospital.de
Contact Person Name
Frank Griesinger
Site Name
LMU Klinikum Muenchen AöR
Department Name
Med. Klinik und Poliklinik V
Principal Investigator Name
Amanda Tufman
Principal Investigator Email
Amanda.Tufman@med.uni-muenchen.de
Contact Person Name
Amanda Tufman
Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Christian Grohé
Principal Investigator Email
chistian.grohe@jsd.de
Contact Person Name
Christian Grohé
Contact Person Email
chistian.grohe@jsd.de

Austria

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
32
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Dept. of Thoracic Surgery
Principal Investigator Name
Clemens Aigner
Principal Investigator Email
clemens.aigner@meduniwien.ac.at
Contact Person Name
Clemens Aigner

France

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
17
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumology Allergology
Principal Investigator Name
Youssef OULKHOUIR
Principal Investigator Email
youssef.oulkhouir@chu-angers.fr
Contact Person Name
Youssef OULKHOUIR
Site Name
Centre Hospitalier D Avignon
Department Name
Pneumologie
Principal Investigator Name
Malek Zoghlami Boussofara
Principal Investigator Email
ZOGHLAMI.Malek@ch-avignon.fr
Contact Person Name
Malek Zoghlami Boussofara
Contact Person Email
ZOGHLAMI.Malek@ch-avignon.fr

Italy

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
22
Number Of Sites
10
Number Of Participants
60

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia medica 1
Principal Investigator Name
Marta Brambilla
Principal Investigator Email
marta.brambilla2@istitutotumori.mi.it
Contact Person Name
Marta Brambilla
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology Department
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
UOC Immunoterapia Oncologica
Principal Investigator Name
Michele Maio
Principal Investigator Email
maio@unisi.it
Contact Person Name
Michele Maio
Contact Person Email
maio@unisi.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncology
Principal Investigator Name
Lorenzo Belluomini
Principal Investigator Email
lorenzo.belluomini@univr.it
Contact Person Name
Lorenzo Belluomini
Contact Person Email
lorenzo.belluomini@univr.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Dh Oncologico -Edificio E ingresso 11A
Principal Investigator Name
Adolfo Favaretto
Principal Investigator Email
adolfo.favaretto@aulss2.veneto.it
Contact Person Name
Adolfo Favaretto
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Principal Investigator Name
Federica Biello
Principal Investigator Email
federica.biello@maggioreosp.novara.it
Contact Person Name
Federica Biello
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Thoracic Oncology Division
Principal Investigator Name
Antonio Passaro
Principal Investigator Email
antonio.passaro@ieo.it
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Oncologia
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
SC Oncologia Medica
Principal Investigator Name
Giulio Metro
Principal Investigator Email
giulio.metro@ospedale.perugia.it
Contact Person Name
Giulio Metro
Site Name
Azienda USL Toscana Centro
Department Name
SOC Oncologia Medica
Principal Investigator Name
Daniele Pozzessere
Principal Investigator Email
daniele.pozzessere@uslcentro.toscana.it
Contact Person Name
Daniele Pozzessere

Spain

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
41
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Hospital Universitario Nuestra Senora De Candelaria
Department Name
Medical Oncology
Principal Investigator Name
Larla Mercedes Medina Sánchez
Principal Investigator Email
karlamedinas@yahoo.es
Contact Person Name
Larla Mercedes Medina Sánchez
Contact Person Email
karlamedinas@yahoo.es
Site Name
Hospital De Jerez De La Frontera
Department Name
Medical Oncology
Principal Investigator Name
Maria Angeles Moreno Santos
Principal Investigator Email
angeles.moreno.mam@gmail.com
Contact Person Name
Maria Angeles Moreno Santos
Contact Person Email
angeles.moreno.mam@gmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Paula Espinosa Olarte
Principal Investigator Email
paula.espinosa.olarte@gmail.com
Contact Person Name
Paula Espinosa Olarte
Site Name
Hospital Clinico San Carlos
Department Name
Oncologia medica
Principal Investigator Name
Carlos Aguado
Principal Investigator Email
carlos.aguadodela@salud.madrid.org
Contact Person Name
Carlos Aguado
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Principal Investigator Name
Silvia Sequero López
Principal Investigator Email
silsq90@gmail.com
Contact Person Name
Silvia Sequero López
Contact Person Email
silsq90@gmail.com
Site Name
Complejo Hospitalario Universitario Juan Canalejo
Department Name
ONCOLOGÍA
Principal Investigator Name
Rosario GARCIA CAMPELO
Principal Investigator Email
MA.Rosario.Garcia.Campelo@sergas.es
Contact Person Name
Rosario GARCIA CAMPELO
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Oncologia
Principal Investigator Name
Bartomeu Massuti
Principal Investigator Email
bmasstis@seom.org
Contact Person Name
Bartomeu Massuti
Contact Person Email
bmasstis@seom.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
Alex Martinez Marti
Principal Investigator Email
amartinezmarti@vhio.net
Contact Person Name
Alex Martinez Marti
Contact Person Email
amartinezmarti@vhio.net
Site Name
Hospital Universitario De Cruces
Department Name
Medical Oncology
Principal Investigator Name
Xabier Mielgo-Rubio
Principal Investigator Email
xmielgo@hotmail.com
Contact Person Name
Xabier Mielgo-Rubio
Contact Person Email
xmielgo@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Principal Investigator Name
Sergio Martinez
Principal Investigator Email
smartinezre@santpau.cat
Contact Person Name
Sergio Martinez
Contact Person Email
smartinezre@santpau.cat

Ireland

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
38
Number Of Sites
4
Number Of Participants
50

Sites

Site Name
St Vincent's University Hospital
Department Name
medical Oncology
Principal Investigator Name
Sarah Lochrin
Principal Investigator Email
sarahlochrin@svhg.ie
Contact Person Name
Sarah Lochrin
Contact Person Email
sarahlochrin@svhg.ie
Site Name
Cork University Hospital
Department Name
medical Oncology
Principal Investigator Name
Sinéad Noonan
Principal Investigator Email
sinead.noonan@hse.ie
Contact Person Name
Sinéad Noonan
Contact Person Email
sinead.noonan@hse.ie
Site Name
Beaumont Hospital
Department Name
Oncology
Principal Investigator Name
Jarushka Naidoo
Principal Investigator Email
jarushkanaidoo@beaumont.ie
Contact Person Name
Jarushka Naidoo
Contact Person Email
jarushkanaidoo@beaumont.ie
Site Name
St James's Hospital
Department Name
Medical Oncology
Principal Investigator Name
Patrick Forde
Principal Investigator Email
PaForde@stjames.ie
Contact Person Name
Patrick Forde
Contact Person Email
PaForde@stjames.ie

Sponsor

Primary sponsor

Full Name
ETOP IBCSG Partners Foundation
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Switzerland

Third parties

  • {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"EU QP release, Distribution to study sites","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Frontier Science Foundation-Hellas","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Italy","full_name":"Istituto Europeo Di Oncologia S.r.l.","duties_or_roles":"Biobank","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
LIBTAYO 350 mg concentrate for solution for infusion.
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/19/1376/001)
Starting Dose
350 mg i.v.
Dose Levels
350 mg then 700 mg
Frequency
350 mg every 3 weeks (±3 days) for 4 cycles, then 700 mg every 6 weeks (±1 week) for 6 cycles
Maximum Dose
700 mg

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