Clinical Trials - DataSource by Daiichi Sankyo

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

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.

CONDITIONS

Non-small Cell Lung Cancer

PRODUCT

Dato-DXd

GENDER

ALL

AGE

18 Years

SPONSOR

AstraZeneca

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

228 Global Locations

Trial Summary

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to 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.

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

1. Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC2. Complete surgical resection (R0) of the primary NSCLC3. Unequivocal no evidence of disease at post-surgical4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)5. ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery6. Adequate bone marrow reserve and organ function

1. Sensitizing EGFR mutation and/or ALK alteration2. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening3. Significant pulmonary function compromise4. History of another primary malignancy within 3 years (with exceptions)5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled8. History of active primary immunodeficiency9. Clinically significant corneal disease

This was last updated on 2025-11-06 19:34:39.693.

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