Metastatic nonsquamous or squamous non-small cell lung cancer
Conditions
Brief summary
OS, defined as the time from randomization until death due to any cause..
Detailed description
PFS, defined as the time from randomization until disease progression by RECIST v1.1 as determined by BICR or death due to any cause., ORR, defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 based on BICR., DOR, defined as the time from the earliest date of documented response until earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR., Number of participants experiencing AEs and number of participants discontinuing study drug due to AEs., Population PK parameters (including Cmax, AUC) will be summarized.
Interventions
DRUGAlbotiva 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUG1 mg/ml
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, defined as the time from randomization until death due to any cause.. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization until disease progression by RECIST v1.1 as determined by BICR or death due to any cause., ORR, defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 based on BICR., DOR, defined as the time from the earliest date of documented response until earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR., Number of participants experiencing AEs and number of participants discontinuing study drug due to AEs., Population PK parameters (including Cmax, AUC) will be summarized. | — |
Countries
Bulgaria, Czechia
Outcome results
None listed