OncRef

Clinical Trial: NCT06564844

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2026-09-23

Study Overview

Brief 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.

Official Title

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)

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Drug: Datopotamab Deruxtecan
  • Drug: Rilvegostomig
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Drug: Etoposide
  • Drug: Pemetrexed
  • Drug: Vinorelbine
  • Drug: UFT

Other Study ID Numbers

  • D926TC00001
  • 2024-512195-35-00

Start Date (Actual)

2024-10-15

Primary Completion Date (Actual)

2026-07-10

Study Completion Date (Estimated)

2027-03-31

Enrollment (Actual)

25

Study Type

Interventional

Phase

Phase 3