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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT06931717 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 expression ≥1% is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR mutation is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
What disease stage is eligible?
Stage II or IIIA is required.
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