Actively Recruiting
A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy
Led by ETOP IBCSG Partners Foundation · Updated on 2026-06-01
390
Participants Needed
33
Research Sites
N/A
Total Duration
On this page
Sponsors
E
ETOP IBCSG Partners Foundation
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase III randomized trial to evaluate the effectiveness of adjuvant cemiplimab immunotherapy in patients with surgically removed stage II-IIIA non-small cell lung cancer (NSCLC) who have not received prior adjuvant platinum-based chemotherapy. The study focuses on patients whose tumors show PD-L1 expression of 1% or higher. This trial aims to compare disease-free survival between those receiving cemiplimab and those under observation without additional treatment. Participants in the experimental group receive cemiplimab at a dose of 350 mg intravenously every 3 weeks for 4 cycles, followed by 700 mg intravenously every 6 weeks for 6 cycles or until relapse or unacceptable side effects occur. The control group undergoes observation without adjuvant treatment. The study treatment continues until disease relapse or unacceptable toxicities arise, with strict monitoring throughout. During the trial, patients will be regularly assessed for disease recurrence, survival, and treatment side effects for up to approximately 59 months from randomization. Evaluations include imaging to detect recurrence and monitoring of adverse events according to standardized criteria. Safety and overall survival are also tracked, with follow-up continuing for several years to capture long-term outcomes and treatment impact.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathological stage II to IIIA non-small cell lung cancer
- Complete surgical tumor removal with negative margins (R0)
- Acceptable surgical types: lobectomy, sleeve lobectomy, bilobectomy, pneumectomy, or segmentectomy for tumors ≤2 cm if needed
- No wedge resection allowed
- Lymph node dissection performed per guidelines
- No disease recurrence after surgery
- Tumor PD-L1 expression ≥1% by local test
- Availability of tumor tissue for central PD-L1 testing
- Not receiving or considered for adjuvant platinum-based chemotherapy due to refusal or unfitness
- Estimated life expectancy of at least 3 months
- Recovered from surgery-related complications
- Adequate blood, kidney, and liver function
- Able to comply with study protocol
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during and for 4 months after treatment
- Signed informed consent
You will not qualify if you...
- EGFR-mutant or ALK-rearranged non-small cell lung cancer
- Any small cell lung cancer component
- Prior neoadjuvant or adjuvant systemic treatment for NSCLC
- Participation in another interventional NSCLC clinical trial
- Active progressing malignancy other than NSCLC requiring treatment
- Use of ongoing or recent systemic corticosteroids over 10 mg prednisone/day (except physiologic replacement)
- Significant autoimmune disease requiring immunosuppressive treatment within 5 years
- Encephalitis, meningitis, brain disease, or uncontrolled seizures within 1 year
- Myocardial infarction within 6 months
- Interstitial lung disease or active pneumonitis within 5 years
- Uncontrolled infections including HIV, hepatitis B or C (unless controlled)
- Recent serious infection requiring hospitalization within 2 weeks
- Receipt of live vaccine within 28 days or COVID-19 vaccine within 1 week before randomization
- Prior allogeneic stem cell or organ transplantation
- Known allergy to cemiplimab or its components
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Family member on study team without sponsor approval
- Investigator judgment of unlikely compliance with study procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 39 weeks or until relapse or unacceptable toxicities, whichever occurs first
Participants receive cemiplimab infusions as adjuvant immunotherapy following surgery to prevent cancer recurrence.
10 infusions over up to 39 weeks (4 infusions every 3 weeks, followed by 6 infusions every 6 weeks)
Duration - Up to approximately 59 months from randomization
Participants are monitored for disease recurrence and overall survival after completing treatment or observation.
Regular follow-up visits to monitor health status
Trial Site Locations
Total: 33 locations
1
Wien AKH
Vienna, Austria
Not Yet Recruiting
2
North Estonia Medical Centre Foundation
Talinn, Estonia
Actively Recruiting
3
CHU d'Angers
Angers, France
Not Yet Recruiting
4
Centre hospitalier d'Avignon
Avignon, France
Not Yet Recruiting
5
Evangelische Lungenklinik Berlin
Buch, Germany
Not Yet Recruiting
6
Ruhrlandklinik Essen
Essen, Germany
Not Yet Recruiting
7
LMU München
München, Germany
Actively Recruiting
8
Pius Hospital, University Medicine Oldenburg
Oldenburg, Germany
Not Yet Recruiting
9
Beaumont Hospital
Dublin, Ireland
Not Yet Recruiting
10
St James's Hospital
Dublin, Ireland
Not Yet Recruiting
11
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Italy
Actively Recruiting
12
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Not Yet Recruiting
13
Instituto Europeo di Oncologia (IEO)
Milan, Italy
Actively Recruiting
14
AOU Maggiore della Carità
Novara, Italy
Not Yet Recruiting
15
Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
Not Yet Recruiting
16
University of Perugia, AO SM Misericorida Perugia
Perugia, Italy
Not Yet Recruiting
17
Nuovo Ospedale di Prato Santo Stefano
Prato, Italy
Actively Recruiting
18
Azienda ospedaliero-universitaria Senese Siena
Siena, Italy
Not Yet Recruiting
19
AULSS2 Marca Trevigiana Treviso
Treviso, Italy
Not Yet Recruiting
20
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy
Actively Recruiting
21
National University Hospital
Singapore, Singapore
Actively Recruiting
22
Complejo Hospitalario Universitario
A Coruña, Spain
Actively Recruiting
23
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Spain
Actively Recruiting
24
Hospital Universitario Cruces
Barakaldo, Spain
Not Yet Recruiting
25
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Not Yet Recruiting
26
Hospital Universitario Vall D'Hebron
Barcelona, Spain
Actively Recruiting
27
Hospital Clínico San Cecilio de Granada
Granada, Spain
Not Yet Recruiting
28
Hospital Universitario de Jerez de La Frontera
Jerez de la Frontera, Spain
Actively Recruiting
29
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
30
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Actively Recruiting
31
Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
32
University Hospital Basel
Basel, Switzerland
Actively Recruiting
33
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
Research Team
H
Heidi Roschitzki, PhD
S
Susanne Roux
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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