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Monoclonal Antibodies

Arm 1: Dato-DXd in Combination With Rilvegostomig for Non-Small Cell Lung Cancer (TROPION-Lung10 Trial)

Phase 3

Waitlist Available

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

TROPION-Lung10 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.Check my eligibility

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.See study design

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.

TROPION-Lung10 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) in TROP2 biomarker positive participants.

Progression-Free Survival (PFS) in TROP2 biomarker positive participants.

Secondary outcome measures

Duration of Response (DoR)

Immunogenicity

Objective Response Rate (ORR)

+7 more

TROPION-Lung10 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,612,689 Total Patients Enrolled

Daiichi SankyoIndustry Sponsor

393 Previous Clinical Trials

415,626 Total Patients Enrolled

Suresh S. Ramalingam, MDPrincipal InvestigatorEmory University, Atlanta, Georgia, United States of America.

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How prevalent is the participation of North American clinics in this research?

"At the moment, this study is being conducted at 73 medical facilities. These sites are situated in Wien, Newmarket, Rozzano, and various other locations worldwide. It is advisable to choose a site close to your residence for convenience purposes if you decide to participate."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The study was first posted on April 26, 2024, and most recently edited on April 5, 2024. Although patient enrollment is not active at the moment, it's noteworthy that there are a total of 1519 ongoing clinical trials actively seeking participants."

Answered by AI

Has the combination of Dato-DXd and Rilvegostomig in Arm 1 received FDA authorization?

"Following a thorough evaluation, our team at Power has rated the safety of Arm 1: Dato-DXd combined with Rilvegostomig as 3. This assessment is based on existing efficacy data and numerous rounds of safety data obtained during this Phase 3 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

2024. "Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06357533.