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 - TROPION-Lung12

Study identifier:D926TC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

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)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Datopotamab Deruxtecan, Rilvegostomig, Carboplatin, Cisplatin, Etoposide, Pemetrexed, Vinorelbine, UFT

Sex

All

Estimated Enrollment

660

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 28 Oct 2024
Estimated Primary Completion Date: 03 Nov 2031
Estimated Study Completion Date: 01 Feb 2035

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo

Inclusion and exclusion criteria