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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
* Known tumour PD-L1 expression status defined as TC ≥ 50%
* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
* ECOG performance status of 0 or 1
* Adequate bone marrow reserve and organ function
Exclusion Criteria:
* Prior systemic therapy for advanced/metastatic NSCLC.
* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
* History of another primary malignancy within 3 years
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol.
* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
* History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Has significant pulmonary function compromise, as determined by the investigator
* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
* History of leptomeningeal carcinomatosis
* Known clinically significant corneal disease
* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
* History of active primary immunodeficiency
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 (287)
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
+ 247 more sites — see the full list on the official registry below.
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.
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