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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 weeks
Treatment ~ Varies
Follow Up ~approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 years for reporting.

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
Duration of Response (DoR)
Immunogenicity
Objective Response Rate (ORR)
+7 more

Awards & 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: Dato-DXd in Combination With RilvegostomigExperimental Treatment2 Interventions
Participants in the 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.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,384 Previous Clinical Trials
289,109,747 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
411 Previous Clinical Trials
450,258 Total Patients Enrolled
Suresh S. Ramalingam, MDPrincipal InvestigatorEmory University, Atlanta, Georgia, United States of America.
1 Previous Clinical Trials
28 Total Patients Enrolled
~450 spots leftby Apr 2028
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