TROPION-Lung12
Research type
Research Study
Full 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
IRAS ID
1010075
Contact name
Yehan Wijesinghe
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers are looking for better ways to improve outcomes for patients with Stage I non-small cell lung carcinoma (NSCLC) post-surgery. Surgery is considered curative for this patient population, however the rates of disease recurrence 5 years after surgery are highly variable (15% to 40%). This study will focus on novel biomarkers that are required to identify patients with a high risk of recurrence.
Detection of ctDNA pre-surgery represents a novel biomarker capable of differentiating indolent lung adenocarcinoma biology from aggressive biology with propensity for recurrence.
Below interventions will be used in the study:
Rilvegostomig is a bispecific immune checkpoint inhibitor (CPI) meaning that it targets two proteins, PD-L1 and TIGIT, at the same time.
Dato-DXd is designed to target a protein called TROP2, found at high levels on the surface of some cancer cells.
Researchers believe that the combination of Dato-DXd and rilvegostomig may offer improved efficacy in the patient population of interest. The preliminary efficacy data from the ongoing studies where Dato-DXd is used as monotherapy or in combination with anti-PD-(L)1 agents with or without chemotherapy, and where bispecific rilvegostomig is used as monotherapy, are promising.
These data support the hypothesis that the combination of Dato-DXd and bispecific rilvegostomig has the potential to address the unmet medical need for an effective and tolerable adjuvant treatment which can reduce the risk of disease recurrence.
Patients will be randomly assigned to one of three treatment arms:
Experimental - Dato-DXd + Rilvegostomig
Experimental - Rilvegostomig alone
Control - SoC (observation or investigator’s choice of chemotherapy)
Rilvegostomig, Dato-DXd and SoC chemotherapy are all given through a needle directly into a vein.
Participants will receive trial treatment for up to 12 months/18 cycles (whichever is earlier). This trial will include about 660 participants.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0096
Date of REC Opinion
7 Oct 2024
REC opinion
Further Information Favourable Opinion