Resectable Non-small cell lung cancer
Conditions
Brief summary
The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.
Detailed description
Overall survival (OS): defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive, Safety and tolerability: will be measured by incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Adverse events will be graded according to CTCAE v5.0
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Fundacion GECP
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS): defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive, Safety and tolerability: will be measured by incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Adverse events will be graded according to CTCAE v5.0 | — |
Countries
Spain
Outcome results
None listed