A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression
The purpose of this study is to learn about whether an investigational drug called rilvegostomig, when used alone or in combination with another anti-cancer drug called datopotamab deruxtecan (also called Dato-DXd) will work and be safe for the treatment of the type of cancer you have, which is called locally advanced or metastatic non-squamous NSCLC. In this study, we will be comparing the experimental treatment with an approved treatment called pembrolizumab. This study will also help us to better understand the studied condition and associated health problems.
- Category
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
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ERM Project ID
106148
Trial contact details
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Contact person
RIO Clinical Trials
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Phone
61 7 31631369
What you need to know
Who can take part
- Documented diagnosis of non-squamous NSCLC
- Stage IIIB or IIIC or Stage IV metastatic NSCLC not suitable for curative surgery or definitive chemoradiation
- Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
Patients who have received prior systemic therapy for advanced/metastatic NSCLC are not suitable for this trial.
What is involved for you
If you agree to take part in this study and the study is suitable for you, your participation will last approximately 66 months.
The study will have three periods:
- Screening period before you start taking the study treatment: up to 28 days and one study visit.
- Treatment period when you will be randomised to a study drug or standard of care comparator. Each three week cycle and one study visit per cycle. During these visits you may have a physical exams, ECG, blood tests, eye exams, tumour assessments (ie-CT scans)
- Follow-up period after you have finished taking the study treatment: up to 90 days after your last dose, two study visits, then every three months.
Trial dates
July 2024 - August 2027
