A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Summary

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Timeline

Start

2024-10-15

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Jones DR, Opitz I, Harpole D, Yanagawa J, Lim E, Tsutani Y, Tan DSW, Dacic S, Ganti AK, Bodla S, Batig A, Lyfar P, Forcina A, Felip E. TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2026 Jan;171(1):1-9. doi: 10.1016/j.jtcvs.2025.09.017. Epub 2025 Sep 19.

Drugs

Indications