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NCT05450692 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
A Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 594
- Enrollment target
- 20
- Study locations
NCT05450692: Active Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by AstraZeneca.
NCT05450692 is a Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 594 participants, above the 280-participant average among 3 other Advanced or Metastatic Non-Small-Cell Lung Cancer trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05450692, a Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 594 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Primary Outcome
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Durvalumab
- DRUG Ceralasertib
Study Locations (20)
California
- Research Site - Los Alamitos
- Research Site - Los Angeles
- Research Site - Whittier
Florida
- Research Site - Jacksonville
- Research Site - Orlando
- Research Site - Tampa
Maryland
- Research Site - Baltimore
- Research Site - Bethesda
- Research Site - Rockville
Georgia
- Research Site - Athens
- Research Site - Atlanta
North Carolina
- Research Site - Charlotte
- Research Site - Winston-Salem
Alabama
- Research Site - Mobile
Arizona
- Research Site - Chandler
Indiana
- Research Site - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 594 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 3 |
What the registry record for NCT05450692 still lists
NCT05450692 is an interventional study that assigns participants to a tested intervention. The registered 594 participants enrollment target is mid-sized for trials with a published cap, above the 280-participant average among 3 other Advanced or Metastatic Non-Small-Cell Lung Cancer trials with a reported enrollment target (112% higher).
The record links to 1 condition, with Advanced or Metastatic Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT05450692 names 20 study sites across 12 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05450692 about?
NCT05450692 is a clinical study titled "A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy". This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
What is the current status of trial NCT05450692?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 594 participants. The study started on 2022-09-15. Estimated completion is 2026-10-30.
What conditions does trial NCT05450692 study?
This clinical trial studies the following conditions: Advanced or Metastatic Non-Small-Cell Lung Cancer.
What interventions are being tested in trial NCT05450692?
The interventions under investigation include: Docetaxel (DRUG), Durvalumab (DRUG), Ceralasertib (DRUG).
Who is sponsoring clinical trial NCT05450692?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450692 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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