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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

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.

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