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NCT06564844 · ClinicalTrials.gov registry record · Phase 3
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT06564844: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
NCT06564844 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 24 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06564844, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Primary Outcome
The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of DFS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- DRUG Datopotamab Deruxtecan
- DRUG Rilvegostomig
Study Locations (20)
California
- Research Site - Duarte
- Research Site - Glendale
- Research Site - Los Angeles
Illinois
- Research Site - Chicago
- Research Site - Evanston
- Research Site - Zion
Florida
- Research Site - Jacksonville
- Research Site - St. Petersburg
Michigan
- Research Site - Farmington Hills
- Research Site - Grand Rapids
Arizona
- Research Site - Tucson
Colorado
- Research Site - Lone Tree
District of Columbia
- Research Site - Washington D.C.
Kansas
- Research Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-10-15 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What the registry record for NCT06564844 still lists
NCT06564844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06564844 names 20 study sites across 14 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT06564844 about?
NCT06564844 is a clinical study titled "A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features". This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as deter...
What is the current status of trial NCT06564844?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2024-10-15. Estimated completion is 2027-06-30.
What conditions does trial NCT06564844 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06564844?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Datopotamab Deruxtecan (DRUG), Rilvegostomig (DRUG).
Who is sponsoring clinical trial NCT06564844?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06564844 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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