Metastatic Non-Small Cell Lung Cancer (mNSCLC)
Conditions
Brief summary
Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%., Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%.
Detailed description
Overall survival in all randomized patients, Progression Free Survival in all randomized participants.
Interventions
DRUGvolrustomig
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGMycofit
DRUG250 mg
DRUGkapsułki twarde
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%., Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival in all randomized patients, Progression Free Survival in all randomized participants. | — |
Countries
Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain
Outcome results
None listed