Newly diagnosed NSCLC with resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2])
Conditions
Brief summary
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
Detailed description
Overall survival (OS), Distant metastasis-free survival (DMFS) as assessed by investigator, DFS as assessed by investigator, Lung cancer specific survival (LCSS), Number of participants who experience an Adverse Event (AE), Number of participants who discontinue study intervention due to AEs, Change from Baseline in Global health status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30), Change from Baseline in Physical functioning score (QLQ-C30 Items 1 to 5), Change from Baseline in Role functioning score (QLQ-C30 Items 6 and 7), Change from Baseline in Dyspnea scores (QLQ-C30 Item 8), Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52), Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Distant metastasis-free survival (DMFS) as assessed by investigator, DFS as assessed by investigator, Lung cancer specific survival (LCSS), Number of participants who experience an Adverse Event (AE), Number of participants who discontinue study intervention due to AEs, Change from Baseline in Global health status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30), Change from Baseline in Physical functioning score (QLQ-C30 Items 1 to 5), Change from Baseline in Role functioning score (QLQ-C30 Items 6 and 7), Change from Baseline in Dyspnea scores (QLQ-C30 Item 8), Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52), Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain