Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-05-13
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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-Lung15
Brief Summary:
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
Detailed Description:
This is a Phase III open-label 3-arm multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation EGFRm locally advanced or metastatic non-small cell lung cancer NSCLC whose disease has progressed on prior osimertinib treatment
Participants will be randomized in a 111 ratio to one of the following intervention groups
1 Dato-DXd osimertinib combination therapy
2 Dato-DXd monotherapy
3 Platinum-based doublet chemotherapy
Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors Version 11 RECIST v11 -defined radiological progression by the investigator unacceptable toxicity or other discontinuation criterion is met
After study intervention discontinuation all participants will undergo an end of treatment EoT visit within 35 days of discontinuation and will be followed up for safety assessments 28 7 days after their last dose of study intervention
Participants will be randomized in a 111 ratio to one of the following intervention groups
1 Dato-DXd osimertinib combination therapy
2 Dato-DXd monotherapy
3 Platinum-based doublet chemotherapy
Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors Version 11 RECIST v11 -defined radiological progression by the investigator unacceptable toxicity or other discontinuation criterion is met
After study intervention discontinuation all participants will undergo an end of treatment EoT visit within 35 days of discontinuation and will be followed up for safety assessments 28 7 days after their last dose of study intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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