Completely resected stage I or IIA non-squamous non-small cell lung cancer (NSCLC)
Conditions
Brief summary
The primary efficacy analysis is based on the duration of DFS in patients determined to be at High- and Intermediate Risk by the 14-Gene Prognostic Assay. DFS is defined as the time from randomization to disease recurrence, or death from any cause. Patients without events at the time of analysis will be censored at their last known event-free date. The primary efficacy analysis will be based on the modified intent-to-treat (mITT) population.
Detailed description
The key secondary efficacy analysis is based on the duration of DFS in patients in the standard intent-to-treat (ITT) population. Patients without events at the time of analysis will be censored at their last known event-free date. An additional key secondary efficacy analysis is based on the duration of DFS in the per-protocol (PP) population., Additional Secondary analysis: OS in patients determined to be at High or Intermediate Risk by the 14-Gene Prognostic Assay is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date., Time to recurrence (TTR) in patients determined to be at High or Intermediate Risk by the 14-Gene Prognostic Assay is defined as length of time from randomization until documented disease recurrence, with death as a competing risk. For TTR, recurrences that are first diagnosed at time of death will be treated as recurrences at date of death. Patients without documented recurrence will be censored at their last documented FU. These analyses will be undertaken for mITT, ITT and PP populations., An additional secondary endpoint of the trial is to compare OS and, to the degree possible, DFS and TTR in patients identified by the 14-Gene Prognostic Assay as High or Intermediate risk stage I or IIA non-squamous NSCLC randomized to observation with patients identified by the 14-Gene Prognostic Assay as Low-Risk stage I or IIA non-squamous NSCLC.
Interventions
DRUGCARBOPLATIN
DRUGPACLITAXEL
DRUGDOCETAXEL
DRUGVINORELBINE TARTRATE
DRUGCISPLATIN
DRUGPEMETREXED
Sponsors
Razor Genomics Inc., Intergroupe Francophone De Cancerologie Thoracique
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy analysis is based on the duration of DFS in patients determined to be at High- and Intermediate Risk by the 14-Gene Prognostic Assay. DFS is defined as the time from randomization to disease recurrence, or death from any cause. Patients without events at the time of analysis will be censored at their last known event-free date. The primary efficacy analysis will be based on the modified intent-to-treat (mITT) population. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy analysis is based on the duration of DFS in patients in the standard intent-to-treat (ITT) population. Patients without events at the time of analysis will be censored at their last known event-free date. An additional key secondary efficacy analysis is based on the duration of DFS in the per-protocol (PP) population., Additional Secondary analysis: OS in patients determined to be at High or Intermediate Risk by the 14-Gene Prognostic Assay is defined to be the time from randomization to death. Patients alive at the end of the analysis will be censored at their last known alive date., Time to recurrence (TTR) in patients determined to be at High or Intermediate Risk by the 14-Gene Prognostic Assay is defined as length of time from randomization until documented disease recurrence, with death as a competing risk. For TTR, recurrences that are first diagnosed at time of death will be treated as recurrences at date of death. Patients without documented recurrenc | — |
Countries
France, Germany
Outcome results
None listed