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
Condition(s) studied
Investigational drug(s) / intervention(s)
Datopotamab Deruxtecan: Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig: Rilvegostomig IV (intravenous)
Pembrolizumab: Pembrolizumab IV (intravenous)
Study summary
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) in TROP2 biomarker positive participants. — Approximately 4 years
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis. - Overall Survival (OS) in TROP2 biomarker positive participants. — Approximately 6 years
OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of OS.
Trial sites (289)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Anchorage | Alaska | Recruiting |
| Research Site | Tucson | Arizona | Recruiting |
| Research Site | Little Rock | Arkansas | Recruiting |
| Research Site | Springdale | Arkansas | Recruiting |
| Research Site | Anaheim | California | Recruiting |
| Research Site | Beverly Hills | California | Recruiting |
| Research Site | Fountain Valley | California | Recruiting |
| Research Site | Newport Beach | California | Suspended |
| Research Site | Clermont | Florida | Recruiting |
| Research Site | Gainesville | Florida | Recruiting |
| Research Site | Miami Beach | Florida | Recruiting |
| Research Site | Orange City | Florida | Recruiting |
| Research Site | Orlando | Florida | Recruiting |
| Research Site | Orlando | Florida | Withdrawn |
| Research Site | West Palm Beach | Florida | Recruiting |
| Research Site | Atlanta | Georgia | Suspended |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Atlanta | Georgia | Withdrawn |
| Research Site | Hinsdale | Illinois | Recruiting |
| Research Site | Noblesville | Indiana | Recruiting |
| Research Site | Paducah | Kentucky | Recruiting |
| Research Site | Annapolis | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Dearborn | Michigan | Recruiting |
| Research Site | Farmington Hills | Michigan | Recruiting |
| Research Site | Grand Rapids | Michigan | Recruiting |
| Research Site | Traverse City | Michigan | Withdrawn |
| Research Site | Hattiesburg | Mississippi | Recruiting |
| Research Site | Kansas City | Missouri | Recruiting |
| Research Site | Bozeman | Montana | Withdrawn |
| Research Site | Grand Island | Nebraska | Recruiting |
| Research Site | Omaha | Nebraska | Recruiting |
| Research Site | Las Vegas | Nevada | Recruiting |
| Research Site | Reno | Nevada | Withdrawn |
| Research Site | Voorhees Township | New Jersey | Suspended |
| Research Site | Stony Brook | New York | Recruiting |
| Research Site | Greenville | North Carolina | Recruiting |
| Research Site | Salisbury | North Carolina | Recruiting |
+ 249 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More AstraZeneca trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06357533 on ClinicalTrials.gov ↗ ← All trials in Italy