TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I NSCLC

David R. Jones

doi:10.1016/j.jtcvs.2025.09.017

TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I NSCLC

2025-09-19

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PRE

AI

D

David R. Jones *

I

Isabelle Opitz

D

David H. Harpole

J

Jane Yanagawa

E

Eric Lim

Y

Yasuhiro Tsutani

D

Daniel Shao-Weng Tan

S

Sanja Đačić

A

Apar Kishor Ganti

A

Anastasiya Batig

P

Pavlo Lyfar

A

Alessandra Forcina

E

Enriqueta Felip

DOI：10.1016/j.jtcvs.2025.09.017

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Abstract

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Five-year disease recurrence rates for patients with stage I non-small cell lung cancer (NSCLC) post-surgery are variable (15%-40%). There is an urgent need for novel biomarker strategies to identify high-risk patients who may benefit from adjuvant treatment. High-risk pathological features, including high-grade histology and lymphovascular or visceral pleural invasion, serve as independent risk factors for worse outcomes. Pre-operative circulating tumor DNA (ctDNA) detection is also correlated with poorer outcomes in stage I NSCLC. Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate composed of a humanized anti-TROP2 antibody conjugated to a potent topoisomerase I inhibitor via a plasma-stable linker, and rilvegostomig, an Fc-reduced, monovalent, bispecific, humanized IgG1 antibody targeting both PD-1 and TIGIT receptors, have shown promise in NSCLC studies. Combining Dato-DXd with rilvegostomig may improve treatment outcomes in select patients with stage I NSCLC.

TROPION-Lung12: A phase 3 study of adjuvant datopotamab deruxtecan and rilvegostomig in ctDNA-positive or high-risk pathology stage I NSCLC

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