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

Recruiting · NCT06357533 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

Datopotamab Deruxtecan Pembrolizumab Rilvegostomig

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 29 US states.

Research Site - Anchorage, Alaska, United States
Research Site - Tucson, Arizona, United States
Research Site - Little Rock, Arkansas, United States
Research Site - Springdale, Arkansas, United States
Research Site - Anaheim, California, United States
Research Site - Beverly Hills, California, United States
Research Site - Fountain Valley, California, United States
Research Site - Newport Beach, California, United States
Research Site - Clermont, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Miami Beach, Florida, United States
Research Site - Orange City, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - West Palm Beach, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Hinsdale, Illinois, United States
Research Site - Noblesville, Indiana, United States
Research Site - Paducah, Kentucky, United States
Research Site - Annapolis, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - Boston, Massachusetts, United States
Research Site - Dearborn, Michigan, United States
Research Site - Farmington Hills, Michigan, United States
Research Site - Grand Rapids, Michigan, United States
Research Site - Traverse City, Michigan, United States
Research Site - Hattiesburg, Mississippi, United States
Research Site - Kansas City, Missouri, United States
Research Site - Bozeman, Montana, United States
Research Site - Grand Island, Nebraska, United States
Research Site - Omaha, Nebraska, United States
Research Site - Las Vegas, Nevada, United States
Research Site - Reno, Nevada, United States
Research Site - Voorhees Township, New Jersey, United States
Research Site - Stony Brook, New York, United States
Research Site - Greenville, North Carolina, United States
Research Site - Salisbury, North Carolina, United States
Research Site - Cincinnati, Ohio, United States
Research Site - Columbus, Ohio, United States
Research Site - Maumee, Ohio, United States
Research Site - Toledo, Ohio, United States
Research Site - Portland, Oregon, United States
Research Site - Greenville, South Carolina, United States
Research Site - Sioux Falls, South Dakota, United States
Research Site - Chattanooga, Tennessee, United States
Research Site - Knoxville, Tennessee, United States
Research Site - Fort Worth, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Houston, Texas, United States
Research Site - Kingwood, Texas, United States
Research Site - Odessa, Texas, United States
Research Site - Fort Belvoir, Virginia, United States
Research Site - Leesburg, Virginia, United States
Research Site - Midlothian, Virginia, United States
Research Site - Richmond, Virginia, United States
Research Site - Tacoma, Washington, United States

Showing 60 of 287 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →