OncoMatch/Clinical Trials/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
Is NCT06931717 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Cemiplimab for non-small cell lung cancer.
Treatment: Cemiplimab — 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%.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥1% (≥1%)
Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test
Excluded: EGFR mutation
EGFR-mutant ... NSCLC [excluded]
Excluded: ALK fusion
ALK-rearranged NSCLC [excluded]
Disease stage
Required: Stage II, IIIA
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: neoadjuvant systemic therapy
Prior neoadjuvant ... systemic treatment for NSCLC [excluded]
Cannot have received: adjuvant systemic therapy
Prior ... adjuvant systemic treatment for NSCLC [excluded]
Lab requirements
Blood counts
adequate haematological function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify