Clinical Trial: NCT06350097
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
Status:
RECRUITINGPhase:
Phase 3| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-26 |
Study Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.
Study details include:
- The study duration will be event-driven, with an estimated duration of approximately 8 years.
- Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.
- The visit frequency will be every 3 weeks during the treatment period.
Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd 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 or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
Official Title
Conditions
Intervention / Treatment
- Drug: Osimertinib
- Drug: Datopotamab Deruxtecan
Other Study ID Numbers
- D516NC00001
- 2023-509883-89-00
- 2023
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-08-26 |
Study Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.
Study details include:
- The study duration will be event-driven, with an estimated duration of approximately 8 years.
- Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.
- The visit frequency will be every 3 weeks during the treatment period.
Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd 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 or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
Official Title
Conditions
Intervention / Treatment
- Drug: Osimertinib
- Drug: Datopotamab Deruxtecan
Other Study ID Numbers
- D516NC00001
- 2023-509883-89-00
- 2023