Non−Small Cell Lung Cancer
Conditions
Brief summary
1. DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First recurrence of NSCLC, as determined by the investigator after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status Occurrence of new primary NSCLC, as assessed by the investigator Death from any cause
Detailed description
1. OS, defined as the time from randomization to death from any cause, 2. DFS rates at 3 years and 5 years in the PD-L1-subpopulation and in the Stage II-IIIA population and in the ITT population, 3. DFS in the PD-L1-subpopulation within patients with Stage II-IIIA NSCLC
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First recurrence of NSCLC, as determined by the investigator after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status Occurrence of new primary NSCLC, as assessed by the investigator Death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OS, defined as the time from randomization to death from any cause, 2. DFS rates at 3 years and 5 years in the PD-L1-subpopulation and in the Stage II-IIIA population and in the ITT population, 3. DFS in the PD-L1-subpopulation within patients with Stage II-IIIA NSCLC | — |
Countries
France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed