Non-small cell lung cancer
Conditions
Brief summary
DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Detailed description
OS, defined as the time from randomization until death from any cause, Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGBI 1810631
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS by investigator's assessment. DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as the time from randomization until death from any cause, Occurrence of trial-related AEs ≥ Grade 3, graded according to CTCAE version 5.0, from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start | — |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Romania, Spain, Sweden
Outcome results
None listed