At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 744 target
Drug / intervention
Dato-DXd +4 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Histologically or cytologically confirmed non-squamous NSCLC
- ✓Documented pre-existing EGFR mutations (Ex19del, L858R, G719X, S768I, L861Q, or combinations including T790M)
- ✓Documented extra-cranial radiologic progression on prior osimertinib monotherapy as most recent line of treatment
- ✓≤2 prior lines of EGFR TKIs with osimertinib as only permitted third generation EGFR TKI
Key exclusion· 12
- ✕Chemotherapy, VEGF inhibitor, immunotherapy, or anti-cancer therapy in metastatic setting
- ✕Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization
- ✕History of another primary malignancy except those treated with curative intent with no active disease within 2 years
- ✕Severe or uncontrolled systemic diseases including active bleeding, active infection, active ILD/pneumonitis, cardiac disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Dato-DXd, Osimertinib, and 3 other interventions for Metastatic Non-small Cell Lung Cancer. Currently recruiting, targeting 744 participants across 303 sites in 27 countries.
Signals
Enrolling ahead of pace
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non-small Cell Lung Cancer
CountriesAustralia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States, Vietnam
CollaboratorsDaiichi Sankyo
Timeline
Phase 3Recruiting
2025202620272028
First PostedMay 2024
Enrollment StartOct 2024
TodayJul 2026
Primary CompletionSep 2026
Study CompletionSep 2028
First PostedMay 16, 2024
Enrollment StartOct 4, 2024
Primary CompletionSep 30, 2026
Study CompletionSep 27, 2028
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 2.1 years agoPrimary completion in 3 months
Interventions
Dato-DXddrug
Dato-DXd will be administered as IV infusion.
Osimertinibdrug
Osimertinib will be administered orally.
Pemetrexeddrug
Pemetrexed will be administered as IV infusion.
Carboplatindrug
Carboplatin will be administered as IV infusion.
Cisplatindrug
Cisplatin will be administered as IV infusion.