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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DRUG

Cemiplimab

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.

Sponsors & Collaborators

Principal Investigators

  • Ross Soo, MB BS, PhD, FRACP · National University Hospital, Singapore

  • Patrick Forde, MD, MBBCh, PhD · Trinity St James Cancer Institute, Dublin, Ireland

  • Servet Bölükbas, MHBA, FETCS, FEBTS, FCCP · Universitätsmedizin Essen - Ruhrlandklinik Lungenkrebszentrum am Westdeutsches Tumorzentrum (LWTZ), Essen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • Austria
  • Estonia
  • France
  • Germany
  • Ireland
  • Italy
  • Singapore
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06931717 on ClinicalTrials.gov