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Study identifier: NCT06931717 Synced from ClinicalTrials.gov · July 29, 2026
● 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

Condition: Non-Small Cell Lung Cancer  ·  Sponsor: ETOP IBCSG Partners Foundation

PhasePhase 3
Planned participants390
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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%.

This description comes directly from the study's public registry record.

Talk to the study team

Heidi Roschitzki, PhD  ·  +41 31 511 94 00  ·  heidi.roschitzki@etop.ibcsg.org

Susanne Roux  ·  +41 31 511 94 00  ·  ARCH@etop.ibcsg.org

Always discuss trial participation with your own doctor first.

Locations (35)

Wien AKHVienna, AustriaNot Yet Recruiting
North Estonia Medical Centre FoundationTalinn, EstoniaRecruiting
CHU d'AngersAngers, FranceNot Yet Recruiting
Centre hospitalier d'AvignonAvignon, FranceNot Yet Recruiting
Evangelische Lungenklinik BerlinBuch, GermanyNot Yet Recruiting
Ruhrlandklinik EssenEssen, GermanyRecruiting
LMU MünchenMünchen, GermanyRecruiting
Pius Hospital, University Medicine OldenburgOldenburg, GermanyNot Yet Recruiting
Cork University HospitalCork, IrelandNot Yet Recruiting
Beaumont HospitalDublin, IrelandRecruiting
St James's HospitalDublin, IrelandRecruiting
St. Vincent's University HospitalDublin, IrelandNot Yet Recruiting

+ 23 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06931717