Non-Small Cell Lung CancerPhase 3ARCHNCT06931717

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

A Phase 3 study testing Cemiplimab in people with Non-Small Cell Lung Cancer, run by ETOP IBCSG Partners Foundation at 35 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Cemiplimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 390 participants
Where: 35 sitesin 9 countries
Study dates: 12 Jan 2026to Mar 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Show all 32Show fewer

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.

Trial locations and contacts

35 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Heidi Roschitzki, PhD contact

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

Susanne Roux contact

+41 31 511 94 00

ARCH@etop.ibcsg.org

Country

City, postcode or hospital

Sites recruiting now only

35 sites in 9 countries

Italy10 sites, 10 recruiting

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
Angelo Delmonte, angelo.delmonte@irst.emr.it
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Marta Brambilla, marta.brambilla2@istitutotumori.mi.it
Not yet recruiting
Instituto Europeo di Oncologia (IEO)
Milan
Antonio Passaro, antonio.passaro@ieo.it
Recruiting
AOU Maggiore della Carità
Novara
Federica Biello, gloria.borra@maggioreosp.novara.it
Not yet recruiting
Fondazione IRCCS Policlinico S. Matteo
Pavia
Francesco Agustoni, f.agustoni@smatteo.pv.it
Recruiting
University of Perugia, AO SM Misericorida Perugia
Perugia
Giulio Metro, giulio.metro@ospedale.perugia.it
Not yet recruiting
Nuovo Ospedale di Prato Santo Stefano
Prato
Daniele Pozzessere
Recruiting
Azienda ospedaliero-universitaria Senese Siena
Siena
Michele Maio, maio@unisi.it
Not yet recruiting
AULSS2 Marca Trevigiana Treviso
Treviso
Adolfo Favaretto, ADOLFO.FAVARETTO@AULSS2.VENETO.IT
Not yet recruiting
Azienda Ospedaliera Universitaria Integrata di Verona
Verona
Lorenzo Belluomini, lorenzo.belluomini@univr.it
Recruiting

Other trials in Italy

Spain10 sites, 10 recruiting

Complejo Hospitalario Universitario
A Coruña
Rosario Garcia Campelo, ma.rosario.garcia.campelo@sergas.es
Recruiting
Hospital General Universitario Dr. Balmis de Alicante
Alicante
Bartomeu Massuti, tomeumassutis@gmail.com
Recruiting
Hospital Universitario Cruces
Barakaldo
Xabier Mielgo, xabier.mielgorubio@osakidetza.eus
Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona
Sergio Martinez Recio, smartinezre@santpau.cat
Recruiting
Hospital Universitario Vall D'Hebron
Barcelona
Alex Martinez Marti, amartinezmarti@vhio.net
Recruiting
Hospital Clínico San Cecilio de Granada
Granada
Silvia Sequero Lopez, silsq90@gmail.com
Recruiting
Hospital Universitario de Jerez de La Frontera
Jerez de la Frontera
Mª Ángeles Moreno Santos, angeles.moreno.mam@gmail.com
Recruiting
Hospital Clínico San Carlos
Madrid
Carlos Aguado, carlos.aguado84@gmail.com
Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
Karla Medina Sánchez, Karlamedinas510@gmail.com
Recruiting
Hospital General Universitario de Valencia
Valencia
Paula Espinosa Olarte, paula.espinosa.olarte@gmail.com
Recruiting

Other trials in Spain

Germany4 sites, 4 recruiting

Evangelische Lungenklinik Berlin
Buch
Christian Grohé, christian.grohe@jsd.de
Not yet recruiting
Ruhrlandklinik Essen
Essen
Servet Bölükbas, servet.boeluekbas@rlk.uk-essen.de
Recruiting
LMU München
München
Amanda Tufman, amanda.tufman@med.uni-muenchen.de
Recruiting
Pius Hospital, University Medicine Oldenburg
Oldenburg
Frank Griesinger, frank.griesinger@pius-hospital.de
Recruiting

Other trials in Germany

Ireland4 sites, 4 recruiting

Cork University Hospital
Cork
Sinead Noonan
Not yet recruiting
Beaumont Hospital
Dublin
Jarushka Naidoo, jarushkanaidoo@beaumont.ie
Recruiting
St James's Hospital
Dublin
Patrick Forde, PaForde@stjames.ie
Recruiting
St. Vincent's University Hospital
Dublin
Sarah Lochrin
Not yet recruiting

Other trials in Ireland

France2 sites, 2 recruiting

CHU d'Angers
Angers
Youssef Oulkhouir, youssef.oulkhouir@chu-angers.fr
Recruiting
Centre hospitalier d'Avignon
Avignon
Malek Zoghlami, zoghlami.malek@ch-avignon.fr
Not yet recruiting

Other trials in France

Switzerland2 sites, 2 recruiting

University Hospital Basel
Basel
Judith Hafer, judith.hafer@usb.ch
Recruiting
Kantonsspital Winterthur
Winterthur
Laetitia Mauti, laetitia.mauti@ksw.ch
Recruiting

Other trials in Switzerland

Austria1 site, 1 recruiting

Wien AKH
Vienna
Clements Aigner, clemens.aigner@meduniwien.ac.at
Recruiting

Other trials in Austria

Estonia1 site, 1 recruiting

North Estonia Medical Centre Foundation
Talinn
Kersti Oselin, kersti.oselin@regionaalhaigla.ee
Recruiting

Other trials in Estonia

Singapore1 site, 1 recruiting

National University Hospital
Singapore
Ross Soo, ross_soo@nuhs.edu.sg
Recruiting

Other trials in Singapore

About this study

Official title: A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy

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: Non-Small Cell Lung Cancer
Being tested: Cemiplimab
Keywords: NSCLC, Stage II-IIIA NSCLC
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CemiplimabDrug
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.

Study groups in NCT06931717
Study group	Role	What they receive
Experimental Arm: Cemiplimab	Experimental	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. Receives: Drug: Cemiplimab
Control Arm: Observation	No intervention	Observation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease-free survival (DFS)
Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).
Measured: From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.

Secondary outcomes (2)

Overall survival (OS)
OS is defined as the time from the date of randomisation until death from any cause. Censoring (for patients who are not reported as having died) will occur at the date last known to be alive. Patients without post-randomisation information will be censored at the date of randomisation (plus 1 day).
Measured: From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.
Incidence, nature and severity of adverse events according to CTCAE v5.
All safety parameters will be summarised in tables to evaluate the toxicity/safety profile of the protocol treatment.
Measured: From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 2026Mar 2029

First posted17 Apr 2025
Study start12 Jan 2026
Primary completionMar 2029 (estimated)
Study completionMar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 390 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06931717
Sponsor's protocol ID: ETOP 27-23
Acronym: ARCH
Status last verified: Oct 2026
First submitted: 2 Apr 2025
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT06931717
Acronym / sponsor ID: ARCH / ETOP 27-23
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC, Stage II-IIIA NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 390 participants (estimated)
Lead sponsor: ETOP IBCSG Partners FoundationResearch network
Collaborators: Regeneron Pharmaceuticals
Study start: 12 Jan 2026 (actual)
Primary completion: Mar 2029 (estimated)
Study completion: Mar 2029 (estimated)
First posted: 17 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental Arm: Cemiplimab	Experimental	Drug: CemiplimabCemiplimab, 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.
Control Arm: Observation	No intervention	–Observation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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).
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.
Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.

Key exclusion criteria (32 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CemiplimabCemiplimab, 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.	Drug	Experimental Arm: Cemiplimab

Primary outcome

Disease-free survival (DFS)
Time frame: From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.
Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).

2 secondary outcomes

Overall survival (OS)
Time frame: From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.
Incidence, nature and severity of adverse events according to CTCAE v5.
Time frame: From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Heidi Roschitzki, PhD contact

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

Susanne Roux contact

+41 31 511 94 00

ARCH@etop.ibcsg.org

Ross Soo, MB BS, PhD, FRACP study chair

National University Hospital, Singapore

Patrick Forde, MD, MBBCh, PhD study chair

Trinity St James Cancer Institute, Dublin, Ireland

Servet Bölükbas, MHBA, FETCS, FEBTS, FCCP study chair

Universitätsmedizin Essen - Ruhrlandklinik Lungenkrebszentrum am Westdeutsches Tumorzentrum (LWTZ), Essen, Germany

35 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cemiplimab in people with Non-Small Cell Lung Cancer, run by ETOP IBCSG Partners Foundation at 35 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Italy, Spain, Germany, Ireland, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heidi Roschitzki, PhD (+41 31 511 94 00, heidi.roschitzki@etop.ibcsg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.