Non-Small Cell Lung Cancer
Conditions
Brief summary
PFS is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per RECIST 1.1 (for extracranial progression) and CNS RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause
Detailed description
Intracranial PFS is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause, Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause, OS is defined as the length of time from randomization until the date of death due to any cause
Interventions
DRUGPlacebo to Osimertinib - Film-coated tablet - 40mg / 80mg
DRUGCARBOPLATIN
DRUGTAGRISSO 80 mg film-coated tablets
DRUGCISPLATIN
DRUGPEMETREXED
DRUGTAGRISSO 40 mg film-coated tablets
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per RECIST 1.1 (for extracranial progression) and CNS RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial PFS is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause, Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause, OS is defined as the length of time from randomization until the date of death due to any cause | — |
Countries
Germany, Italy, Spain
Outcome results
None listed