ACTIVE_NOT_RECRUITING

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

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

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Official Title

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

Quick Facts

Study Start:2024-10-15
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06564844

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. 1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
  2. 2. Complete surgical resection (R0) of the primary NSCLC
  3. 3. Unequivocal no evidence of disease at post-surgical
  4. 4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
  5. 5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
  6. 6. Adequate bone marrow reserve and organ function
  1. 1. Sensitizing EGFR mutation and/or ALK alteration
  2. 2. 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
  3. 3. Significant pulmonary function compromise
  4. 4. History of another primary malignancy within 3 years (with exceptions)
  5. 5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
  6. 6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  7. 7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
  8. 8. History of active primary immunodeficiency
  9. 9. Clinically significant corneal disease

Contacts and Locations

Principal Investigator

David Jones, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center, New York, United States of America
Enriqueta Felip, MD
PRINCIPAL_INVESTIGATOR
Vall d'Hebron Hospital, Barcelona, Spain

Study Locations (Sites)

Research Site
Tucson, Arizona, 85724
United States
Research Site
Duarte, California, 91010
United States
Research Site
Glendale, California, 91204
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Lone Tree, Colorado, 80124
United States
Research Site
Washington D.C., District of Columbia, 20007
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
St. Petersburg, Florida, 33709
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Evanston, Illinois, 60201
United States
Research Site
Zion, Illinois, 60099
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Baltimore, Maryland, 21237
United States
Research Site
Farmington Hills, Michigan, 48334
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Minneapolis, Minnesota, 55407
United States
Research Site
Billings, Montana, 59102
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
East Syracuse, New York, 13057
United States
Research Site
Mineola, New York, 11501
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10065
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Bethlehem, Pennsylvania, 18015
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
Knoxville, Tennessee, 37920
United States
Research Site
Memphis, Tennessee, 38120
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Austin, Texas, 78745
United States
Research Site
Dallas, Texas, 75231
United States
Research Site
Houston, Texas, 77030
United States
Research Site
San Antonio, Texas, 78217
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Edmonds, Washington, 98026
United States
Research Site
Seattle, Washington, 98104
United States
Research Site
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • David Jones, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center, New York, United States of America
  • Enriqueta Felip, MD, PRINCIPAL_INVESTIGATOR, Vall d'Hebron Hospital, Barcelona, Spain

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 Date2024-10-15
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Non-small Cell Lung Cancer
  • NSCLC
  • Adenocarcinoma
  • Stage I
  • Datopotamab Deruxtecan
  • Dato-DXd
  • Adjuvant Treatment
  • Rilvegostomig
  • Standard of Care
  • Pemetrexed
  • Carboplatin
  • Cisplatin
  • Vinorelbine
  • Etoposide
  • UFT
  • ctDNA-positive
  • High-risk Pathological Features

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer