27-23 ARCH

A randomised phase III trial of adjuvant cemiplimab in patients with resected stage II-IIIA NSCLC who have not received prior adjuvant chemotherapy

The aim of this trial is to determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients with resected stage II-IIIA NSCLC 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%.

Trial Scheme

Trial Information

Primary Endpoint:

Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%)

Secondary Endpoints:

Overall survival
Incidence, nature and severity of adverse events according to CTCAE v5

Exploratory Endpoints:

Subgroup analysis of patients who refuse chemotherapy versus patients who are unfit to receive chemotherapy
Subgroup analysis of patients by centrally confirmed PD-L1 levels 1-49% versus ≥50%
Immune- and NSCLC-related other exploratory biomarkers in tumour tissues, and blood collected within the study

Target Sample Size:

390 randomized patients

Protocol Release Date:

28 February 2025

Trial Organisation

Trial Chair:

Ross Soo, Singapore, Singapore

Trial Co-Chairs:

Patrick Forde, Dublin, Ireland
Servet Bölükbas, Essen, Germany

Sponsor:

ETOP IBCSG Partners Foundation

Coordinating Group:

ETOP IBCSG Partners Foundation

Participating Groups:

Clinical Trials Ireland (CTI) and Spanish Lung Cancer Group (SLCG)

Registrations:

EU CT number: 2024-519901-36
clinicaltrials.gov: NCT06931717

Participating Countries:

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

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
ARCH@etop.ibcsg.org