Stage IV Non Small Cell Lung Cancer whose tumors lack EGFR mutations and ALK fusions
Conditions
Brief summary
Progression-free survival (PFS) defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression)
Detailed description
Overall survival (OS) defined as time from date of randomization until the date of death by any cause, Objective response rate (ORR) defined as percentage of patients with an Investigator-assessed response of CR or PR after randomization, Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression, PFS in HRRm population defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment in HRRm population using RECIST 1.1 or death (by any cause in the absence of progression), Concentration of durvalumab, Disease-related symptoms and HRQoL assessed by change from baseline and time to deterioration (for maintenance phase)in EORTC QLQ-C30 and EORTC QLQ-LC13, Presence of anti-drug antibodies (ADA) for durvalumab, Safety endpoints of AEs, physical examinations, laboratory findings, and vital signs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) defined as time from date of randomization until the date of death by any cause, Objective response rate (ORR) defined as percentage of patients with an Investigator-assessed response of CR or PR after randomization, Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression, PFS in HRRm population defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment in HRRm population using RECIST 1.1 or death (by any cause in the absence of progression), Concentration of durvalumab, Disease-related symptoms and HRQoL assessed by change from baseline and time to deterioration (for maintenance phase)in EORTC QLQ-C30 and EORTC QLQ-LC13, Presence of anti-drug antibodies (ADA) for durvalumab, Safety endpoints of AEs, physical examinations, laboratory find | — |
Countries
Poland