RECRUITING

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Conditions

Metastatic Non-small Cell Lung CancerEpidermal growth factor receptor gene mutationStandard of CareLocally, advanced carcinomaMetastatic carcinomaNon-small cell lung cancerDato-dxdDatopotamab deruxtecanOsimertinibTagrissoPemetrexedCarboplatinCisplatin

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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 study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Official Title

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

Quick Facts

Study Start:2024-10-04
Study Completion:2027-11-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06417814

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 confirmed non-squamous NSCLC.
  2. * Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M).
  3. * Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
  4. * Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
  5. * At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
  6. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. * Adequate bone marrow reserve and organ function within 7 days before randomization.
  1. * Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
  2. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
  3. * Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
  4. * Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
  5. * History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  6. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
  7. * Unstable spinal cord compression and/or unstable brain metastases.
  8. * Participants with symptomatic brain metastases (including leptomeningeal involvement).
  9. * Clinically significant corneal disease.
  10. * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections.
  11. * Has known human immunodeficiency virus (HIV) infection that is not well controlled.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Fayetteville, Arkansas, 72703
United States
Research Site
Duarte, California, 91010
United States
Research Site
La Jolla, California, 92093
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Evanston, Illinois, 60201-1718
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Bethesda, Maryland, 20817
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Morristown, New Jersey, 07960
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10065
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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 Date2024-10-04
Study Completion Date2027-11-29

Study Record Updates

Study Start Date2024-10-04
Study Completion Date2027-11-29

Terms related to this study

Keywords Provided by Researchers

  • Epidermal growth factor receptor gene mutation
  • Standard of Care
  • Locally, advanced carcinoma
  • Metastatic carcinoma
  • Non-small cell lung cancer
  • Dato-dxd
  • Datopotamab deruxtecan
  • Osimertinib
  • Tagrisso
  • Pemetrexed
  • Carboplatin
  • Cisplatin

Additional Relevant MeSH Terms

  • Metastatic Non-small Cell Lung Cancer