Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
Brief summary
OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
Detailed description
To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability., To assess the PK of ceralasertib when administered in combination with durvalumab., To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability., To assess the PK of ceralasertib when administered in combination with durvalumab., To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel | — |
Countries
Belgium, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Spain