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NCT06350097 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 582
- Enrollment target
- 20
- Study locations
NCT06350097 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 582 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06350097, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 582 participants
- Enrollment target
- 20
- Study locations
Study 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: 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 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.
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Datopotamab Deruxtecan
Study Locations (20)
California
- Research Site - Fountain Valley
- Research Site - Los Alamitos
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Orange
- Research Site - San Diego
- Research Site - Santa Monica
- Research Site - Walnut Creek
Florida
- Research Site - Jacksonville
- Research Site - Ocala
- Research Site - Orange City
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Hawaii
- Research Site - Honolulu
Illinois
- Research Site - North Chicago
Indiana
- Research Site - Fort Wayne
Maryland
- Research Site - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2032-05-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06350097
The ClinicalTrials.gov registry entry for NCT06350097 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 582 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (12% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.
NCT06350097 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06350097 about?
NCT06350097 is a clinical study titled "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". 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 detai...
What is the current status of trial NCT06350097?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2024-04-29. Estimated completion is 2032-05-25.
What conditions does trial NCT06350097 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06350097?
The interventions under investigation include: Osimertinib (DRUG), Datopotamab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT06350097?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06350097 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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