NCT06931717

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-12
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-04-17
• Last updated: 2026-04-14

Locations

33 sites across 9 countries: Austria, Estonia, France, Germany, Ireland, Italy, Singapore, Spain, Switzerland