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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

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. Read more about this study

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.
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  • 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.

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%.

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 groupRoleWhat they receive
Experimental Arm: CemiplimabExperimentalCemiplimab, 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: ObservationNo interventionObservation.

What is being measured

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

  1. 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)
  1. 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.

  2. 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.

  1. First posted17 Apr 2025
  2. Study start12 Jan 2026
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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

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?
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.

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