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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Open-label, sponsor-blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig 		Participants in the Datopotamab Deruxtecan (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.
  • Drug: Datopotamab Deruxtecan
    Datopotamab Deruxtecan IV (intravenous)
    Other names:
    • Dato-DXd
  • Drug: Rilvegostomig
    Rilvegostomig IV (intravenous)
    Other names:
    • AZD2936
Experimental
Arm 2: Rilvegostomig Monotherapy 		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.
  • Drug: Rilvegostomig
    Rilvegostomig IV (intravenous)
    Other names:
    • AZD2936
Active Comparator
Arm 3: Pembrolizumab Monotherapy 		Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Drug: Pembrolizumab
    Pembrolizumab IV (intravenous)
    Other names:
    • KEYTRUDA

Recruiting Locations

Research Site
Anchorage, Alaska 99508

Research Site
Tucson, Arizona 85719

Research Site
Little Rock, Arkansas 72205

Research Site
Springdale, Arkansas 72762

Research Site
Anaheim, California 92801

Research Site
Beverly Hills, California 90211

Research Site
Fountain Valley, California 92708

Research Site
Clermont, Florida 34711

Research Site
Gainesville, Florida 32608

Research Site
Miami Beach, Florida 33140

Research Site
Orange City, Florida 32763

Research Site
Orlando, Florida 32806

Research Site
West Palm Beach, Florida 33401

Research Site
Atlanta, Georgia 30318

Research Site
Atlanta, Georgia 30322

Research Site
Hinsdale, Illinois 60521

Research Site
Noblesville, Indiana 46062

Research Site
Paducah, Kentucky 42003

Research Site
Annapolis, Maryland 21401

Research Site
Boston, Massachusetts 02114

Research Site
Boston, Massachusetts 02215

Research Site
Dearborn, Michigan 48126

Research Site
Farmington Hills, Michigan 48334

Research Site
Grand Rapids, Michigan 49503

Research Site
Hattiesburg, Mississippi 39401

Research Site
Kansas City, Missouri 64132

Research Site
Grand Island, Nebraska 68803

Research Site
Omaha, Nebraska 68130

Research Site
Las Vegas, Nevada 89102

Research Site
Stony Brook, New York 11794

Research Site
Greenville, North Carolina 27834

Research Site
Salisbury, North Carolina 28144

Research Site
Cincinnati, Ohio 45219

Research Site
Maumee, Ohio 43537

Research Site
Toledo, Ohio 43623

Research Site
Greenville, South Carolina 29607

Research Site
Sioux Falls, South Dakota 57105

Research Site
Fort Worth, Texas 76104

Research Site
Houston, Texas 77030

Research Site
Kingwood, Texas 77339

Research Site
Odessa, Texas 79761

Research Site
Fort Belvoir, Virginia 22060

Research Site
Leesburg, Virginia 20176

Research Site
Midlothian, Virginia 23114

Research Site
Richmond, Virginia 23230

Research Site
Tacoma, Washington 98405

Research Site
Vancouver, Washington 98684

Research Site
Wenatchee, Washington 98801

Research Site
Appleton, Wisconsin 54911

Research Site
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.