Study identifier:D926TC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Non-small Cell Lung Cancer
Phase 3
No
Datopotamab Deruxtecan, Rilvegostomig, Carboplatin, Cisplatin, Etoposide, Pemetrexed, Vinorelbine, UFT
All
660
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dato-DXd + rilvegostomig Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W). | Drug: Datopotamab Deruxtecan Datopotamab Deruxtecan IV (intravenous) Other Name: Dato-DXd, DS-1062a Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Name: AZD2936 |
Experimental: Rilvegostomig Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W). | Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Name: AZD2936 |
Active Comparator: Standard of Care (SoC) Patients in SoC group will undergo observation or will receive Investigator’s Choice of Chemotherapy (ICC). | Drug: Carboplatin Carboplatin IV (intravenous), Active Comparator Drug: Cisplatin Cisplatin IV (intravenous), Active Comparator Drug: Etoposide Etoposide IV (intravenous), Active Comparator Drug: Pemetrexed Pemetrexed IV (intravenous), Active Comparator Drug: Vinorelbine Vinorelbine IV (intravenous), Active Comparator Drug: UFT UFT Oral route of administration, Active Comparator |