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
Condition(s) studied
Investigational drug(s) / intervention(s)
Ceralasertib: Participants will receive ceralasertib oral tablets.
Durvalumab: Participants will receive durvalumab as an intravenous infusion.
Docetaxel: Participants will received docetaxel as an intravenous infusion.
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.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
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.
Trial sites (191)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Mobile | Alabama | |
| Research Site | Chandler | Arizona | |
| Research Site | Los Alamitos | California | |
| Research Site | Los Angeles | California | |
| Research Site | Whittier | California | |
| Research Site | Jacksonville | Florida | |
| Research Site | Orlando | Florida | |
| Research Site | Athens | Georgia | |
| Research Site | Atlanta | Georgia | |
| Research Site | Fort Wayne | Indiana | |
| Research Site | Baltimore | Maryland | |
| Research Site | Bethesda | Maryland | |
| Research Site | Rockville | Maryland | |
| Research Site | Hattiesburg | Mississippi | |
| Research Site | St Louis | Missouri | |
| Research Site | Omaha | Nebraska | |
| Research Site | Reno | Nevada | |
| Research Site | Charlotte | North Carolina | |
| Research Site | Winston-Salem | North Carolina | |
| Research Site | Canton | Ohio | |
| Research Site | Cleveland | Ohio | |
| Research Site | Allentown | Pennsylvania | |
| Research Site | York | Pennsylvania | |
| Research Site | Houston | Texas | |
| Research Site | Huntsville | Texas | |
| Research Site | Kingwood | Texas | |
| Research Site | Appleton | Wisconsin | |
| Research Site | Buenos Aires | Argentina | |
| Research Site | Pergamino | Argentina | |
| Research Site | Rosario | Argentina | |
| Research Site | Rosario | Argentina | |
| Research Site | San Juan | Argentina | |
| Research Site | Elizabeth Vale | Australia | |
| Research Site | Lismore | Australia | |
| Research Site | Murdoch | Australia | |
| Research Site | South Brisbane | Australia | |
| Research Site | Wollongong | Australia | |
| Research Site | Charleroi | Belgium | |
| Research Site | Ghent | Belgium | |
| Research Site | Libramont-Chevigny | Belgium |
+ 151 more sites — see the full list on the official registry below.
On this site
📄 Imfinzi (durvalumab) drug profile →More AstraZeneca trials in Germany
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05450692 on ClinicalTrials.gov ↗ ← All trials in Germany