Actively Recruiting
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
Led by ETOP IBCSG Partners Foundation · Updated on 2026-04-14
390
Participants Needed
33
Research Sites
163 weeks
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
ARCH is a randomised, stratified, multicentre, phase III trial. Protocol treatment consists of cemiplimab, 350 mg i.v., every 3 weeks, for 4 cycles, followed by 700 mg i.v., every 6 weeks for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first. The primary objective of the study is to determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients without prior adjuvant platinum-based chemotherapy, compared to observation without adjuvant treatment. The primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression of ≥1%.
CONDITIONS
Official 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...
- Pathological stage II-IIIA NSCLC according to UICC/AJCC 9th edition
- Brain imaging completed pre- or postoperatively; if not, must have brain CT or MRI at screening
- Complete surgical removal of tumor with negative margins (R0)
- Acceptable surgery types: lobectomy, sleeve lobectomy, bilobectomy, pneumectomy; segmentectomy allowed for tumors 4 cm if poor lung reserve or major comorbidity
- Wedge resection not allowed
- Lymph node dissection per guidelines
- No disease recurrence after surgery
- Tumor PD-L1 expression 1% by local test
- Archival tumor tissue available for central PD-L1 testing
- Not considered for adjuvant platinum-based chemotherapy due to patient refusal or unfitness (ECOG PS2, or PS 0/1 with age 70 and comorbidities/contraindications)
- Estimated life expectancy 3 months
- Age 18 years
- Recovered from surgery-related complications
- Adequate blood, kidney, and liver function
- Able to comply with trial protocol
- Negative pregnancy test for women of childbearing potential within 5 weeks before randomisation and repeated before treatment and each visit
- Use of highly effective contraception during treatment and for 4 months after last dose
- Signed informed consent prior to any trial procedures
You will not qualify if you...
- EGFR-mutant or ALK-rearranged NSCLC
- Presence of 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 (exceptions: non-melanoma skin cancer, in situ cervical carcinoma, definitively treated non-metastatic prostate cancer)
- Ongoing corticosteroid therapy >10 mg prednisone/day unless physiological replacement
- Significant autoimmune disease treated with systemic immunosuppressants within 5 years
- Encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year
- Myocardial infarction within 6 months
- Interstitial lung disease or active pneumonitis within 5 years
- Uncontrolled HIV, hepatitis B or C infection, or immunodeficiency (controlled HIV/HBV/HCV allowed with monitoring)
- Infection requiring hospitalization or IV antibiotics within 2 weeks before randomisation
- Live vaccine within 28 days before randomisation
- COVID-19 vaccine within 1 week before randomisation
- Prior allogeneic stem cell or organ transplantation or autologous stem cell transplant within 12 weeks
- Known allergy to cemiplimab or its components
- Pregnant, planning pregnancy, or breastfeeding
- Not willing to use effective contraception if sexually active and of childbearing potential
- Immediate family member involved in study team without sponsor approval
- Investigator judgment of unlikely compliance with study requirements
AI-Screening
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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
Not Yet 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
CONTACT
S
Susanne Roux
CONTACT
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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