stage IV NSCLC (non-small-cell lung cancer)
Conditions
Brief summary
Progression-free survival rate at 12 months (PFS@12) according to RECIST 1.1, defined as the proportion of patients alive with non-progressive disease 12 months after enrollment and estimated by the Kaplan-Meier method.
Detailed description
Progression-free survival rate (PFS), defined as time from enrollment to the date of progression according to RECIST 1.1 or death due to any cause, Overall survival (OS), defined as time from enrollment to the date of death due to any cause, Objective response rate (ORR), defined as rate of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as best overall response, Toxicity according to CTCAE 5.0, Progression-free survival rate (PFS2) as defined by time from initial trial randomization to second disease progression or death from any cause
Interventions
DRUGTAGRISSO 80 mg film-coated tablets
DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGTAGRISSO 40 mg film-coated tablets
Sponsors
Universitat Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 12 months (PFS@12) according to RECIST 1.1, defined as the proportion of patients alive with non-progressive disease 12 months after enrollment and estimated by the Kaplan-Meier method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate (PFS), defined as time from enrollment to the date of progression according to RECIST 1.1 or death due to any cause, Overall survival (OS), defined as time from enrollment to the date of death due to any cause, Objective response rate (ORR), defined as rate of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as best overall response, Toxicity according to CTCAE 5.0, Progression-free survival rate (PFS2) as defined by time from initial trial randomization to second disease progression or death from any cause | — |
Countries
Germany
Outcome results
None listed