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Monoclonal Antibodies
Dato-DXd + Rilvegostomig for Non-Small Cell Lung Cancer (TROPION-Lung10 Trial)
Phase 3
Recruiting
Led By Suresh S. Ramalingam, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see how well a new drug called Dato-DXd works when used alone or with another drug, compared to the standard treatment pembrolizumab, for patients with a specific
Who is the study for?
This trial is for adults with advanced non-squamous NSCLC that has high PD-L1 expression (TC ≥ 50%) and no treatable gene changes. Participants should not have had prior therapy for their condition.
What is being tested?
The study tests Dato-DXd with Rilvegostomig or just Rilvegostomig against Pembrolizumab alone in first-line treatment. It aims to see which is more effective and safe for this type of lung cancer.
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss, blood clots, allergic reactions to the drugs being tested, and potential impacts on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS) in TROP2 biomarker positive participants.
Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
Secondary study objectives
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
Immunogenicity
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Rilvegostomig MonotherapyExperimental Treatment1 Intervention
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Group II: Arm 1: Datopotamab Deruxtecan in Combination With RilvegostomigExperimental Treatment2 Interventions
Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Group III: Arm 3: Pembrolizumab MonotherapyActive Control1 Intervention
Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,269 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
423 Previous Clinical Trials
468,788 Total Patients Enrolled
Suresh S. Ramalingam, MDPrincipal InvestigatorEmory University, Atlanta, Georgia, United States of America.
1 Previous Clinical Trials
28 Total Patients Enrolled