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

NCT06931717 | Recruiting Phase 3 DMC

• 1 other identifier: ETOP 27-23
• Study Type: interventional
• Target: 390
• Locations: 8 countries
• Sites: 32

Brief 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. 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

Keywords

NSCLC; Stage II-IIIA NSCLC

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).

  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)

  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.

  From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

Study Arms (2)

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.

Drug: Cemiplimab

Control Arm: Observation

NO INTERVENTION

Observation.

Interventions

Cemiplimab DRUG

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.

Experimental Arm: Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (33)

Wien AKH

Vienna, Austria

NOT YET RECRUITING

North Estonia Medical Centre Foundation

Talinn, Estonia

RECRUITING

CHU d'Angers

Angers, France

NOT YET RECRUITING

Centre hospitalier d'Avignon

Avignon, France

NOT YET RECRUITING

Evangelische Lungenklinik Berlin

Buch, Germany

NOT YET RECRUITING

Ruhrlandklinik Essen

Essen, Germany

NOT YET RECRUITING

LMU München

München, Germany

RECRUITING

Pius Hospital, University Medicine Oldenburg

Oldenburg, Germany

NOT YET RECRUITING

Beaumont Hospital

Dublin, Ireland

NOT YET RECRUITING

St James's Hospital

Dublin, Ireland

NOT YET RECRUITING

IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

NOT YET RECRUITING

Instituto Europeo di Oncologia (IEO)

Milan, Italy

RECRUITING

AOU Maggiore della Carità

Novara, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

NOT YET RECRUITING

University of Perugia, AO SM Misericorida Perugia

Perugia, Italy

NOT YET RECRUITING

Nuovo Ospedale di Prato Santo Stefano

Prato, Italy

RECRUITING

Azienda ospedaliero-universitaria Senese Siena

Siena, Italy

NOT YET RECRUITING

AULSS2 Marca Trevigiana Treviso

Treviso, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Complejo Hospitalario Universitario

A Coruña, Spain

RECRUITING

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Spain

RECRUITING

Hospital Universitario Cruces

Barakaldo, Spain

NOT YET RECRUITING

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Vall D'Hebron

Barcelona, Spain

RECRUITING

Hospital Clínico San Cecilio de Granada

Granada, Spain

NOT YET RECRUITING

Hospital Universitario de Jerez de La Frontera

Jerez de la Frontera, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ross Soo, MB BS, PhD, FRACP

  National University Hospital, Singapore

  STUDY CHAIR

• Patrick Forde, MD, MBBCh, PhD

  Trinity St James Cancer Institute, Dublin, Ireland

  STUDY CHAIR

• Servet Bölükbas, MHBA, FETCS, FEBTS, FCCP

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

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 17, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

FR (2); IE (2); SG (1); ES (10); CH (2); DE (4); AU (1); IT (10)