RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus 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 (TROPION-Lung10)

Quick Facts

Study Start:2024-04-11
Study Completion:2030-05-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06357533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically documented non-squamous NSCLC.
  2. * 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.
  3. * 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.
  4. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
  5. * Known tumour PD-L1 expression status defined as TC ≥ 50%
  6. * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
  7. * ECOG performance status of 0 or 1
  8. * Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
  1. * Prior systemic therapy for advanced/metastatic NSCLC.
  2. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
  3. * History of another primary malignancy within 3 years
  4. * Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  5. * Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
  6. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
  7. * History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  8. * Has significant pulmonary function compromise, as determined by the investigator
  9. * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
  10. * History of leptomeningeal carcinomatosis
  11. * Known clinically significant corneal disease
  12. * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
  13. * History of active primary immunodeficiency

Contacts and Locations

Study Contact

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

Principal Investigator

Suresh S. Ramalingam, MD
PRINCIPAL_INVESTIGATOR
Emory University, Atlanta, Georgia, United States of America.

Study Locations (Sites)

Research Site
Anchorage, Alaska, 99508
United States
Research Site
Tucson, Arizona, 85719
United States
Research Site
Fayetteville, Arkansas, 72703
United States
Research Site
Little Rock, Arkansas, 72205
United States
Research Site
Beverly Hills, California, 90211
United States
Research Site
Glendale, California, 91204
United States
Research Site
Long Beach, California, 90806
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Gainesville, Florida, 32608
United States
Research Site
Miami Beach, Florida, 33140
United States
Research Site
Orlando, Florida, 32827
United States
Research Site
Punta Gorda, Florida, 33980
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Atlanta, Georgia, 30342
United States
Research Site
Stockbridge, Georgia, 30281
United States
Research Site
Indianapolis, Indiana, 46260
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Dearborn, Michigan, 48126
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Royal Oak, Michigan, 48073
United States
Research Site
Traverse City, Michigan, 49684
United States
Research Site
Hattiesburg, Mississippi, 39401
United States
Research Site
Bozeman, Montana, 59715
United States
Research Site
Grand Island, Nebraska, 68803
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
Las Vegas, Nevada, 89102
United States
Research Site
Reno, Nevada, 89502
United States
Research Site
Voorhees, New Jersey, 08043
United States
Research Site
Stony Brook, New York, 11794
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Salisbury, North Carolina, 28144
United States
Research Site
Cincinnati, Ohio, 45219
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Portland, Oregon, 97213
United States
Research Site
Greenville, South Carolina, 29607
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Memphis, Tennessee, 38103
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
Odessa, Texas, 79761
United States
Research Site
Fort Belvoir, Virginia, 22060
United States
Research Site
Leesburg, Virginia, 20176
United States
Research Site
Richmond, Virginia, 23230
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Vancouver, Washington, 98684
United States
Research Site
Wenatchee, Washington, 98801
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Suresh S. Ramalingam, MD, PRINCIPAL_INVESTIGATOR, Emory University, Atlanta, Georgia, United States of America.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-11
Study Completion Date2030-05-24

Study Record Updates

Study Start Date2024-04-11
Study Completion Date2030-05-24

Terms related to this study

Keywords Provided by Researchers

  • NSCLC
  • Non-Small Cell Lung Cancer
  • Datopotamab Deruxtecan
  • Rilvegostomig
  • Pembrolizumab
  • Non-squamous
  • PD-L1 expression >=50%
  • Locally-advanced NSCLC
  • Metastatic NSCLC

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer