Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350097
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-02
Brief Title:
Phase III Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Open-label Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan Dato-DXd as First-line Treatment in Participants With Epidermal Growth Factor Receptor EGFR Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TROPION-Lung14
Brief Summary:
The purpose of this study is to evaluate efficacy and safety of osimertinib tablet in combination with Datopotamab Deruxtecan iv infusion compared with osimertinib tablet monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm Ex19del andor L858R NSCLC
Study details include
1 The study duration will be event-driven with an estimated duration of approximately 9 years
2 Participants may receive study treatment until disease progression unacceptable toxicity or other specific discontinuation criteria are met
3 The visit frequency will be every 3 weeks during the treatment period
Note Participants on osimertinib treatment osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression IP discontinuation or primary PFS DCO Participants who are receiving osimertinib Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks q3w per SoA
Study details include
1 The study duration will be event-driven with an estimated duration of approximately 9 years
2 Participants may receive study treatment until disease progression unacceptable toxicity or other specific discontinuation criteria are met
3 The visit frequency will be every 3 weeks during the treatment period
Note Participants on osimertinib treatment osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression IP discontinuation or primary PFS DCO Participants who are receiving osimertinib Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks q3w per SoA
Detailed Description:
This is a global Phase III open-label randomised multicentre study assessing the efficacy and safety of osimertinib in combination with Datopotamab Deruxtecan compared with osimertinib in participants with locally advanced or metastatic EGFRm Ex19del andor L858R NSCLC who have not received any prior therapy for advanced disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None