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%.
Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at screening prior randomisation.
Complete resection with negative surgical margins (R0).
Lobectomy, sleeve lobectomy, bilobectomy, or pneumectomy.
Segmentectomy for tumours ≤2 cm is permitted in patients with poor pulmonary reserve or another major comorbidity that contraindicates lobectomy.
EGFR-mutant or ALK-rearranged NSCLC.
Any small cell component
Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC.
Treatment with an approved systemic therapy is completed >4 weeks before randomisation or
ETOP IBCSG Partners Foundation
Lead sponsor
Regeneron Pharmaceuticals
Collaborator