Non-Small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
Progression-free survival (PFS) as assessed by independent radiology review (IRR) based on RECIST v. 1.1 criteria.
Detailed description
Key Secondary Efficacy Endpoints: Overall survival, CNS response rate (based on IRR), time to CNS progression (based on IRR), objective response rate (based on IRR), PFS (based on investigator assessment), ORR (based on investigator assessment), Time to response (based on investigator assessment and IRR), Duration of response (based on investigator assessment and IRR), CNS response rate (based on investigator assessment), Time to CNS progression (based on investigator assessment), Patient reported time to deterioration (TTD) as measured by the EORTC C30/LC13 QoL questionnaire and Lung Cancer Symptom Scale (LCSS), Patient reported health-related quality of life (HRQoL) as measured by the EORTC C30/LC13 QoL questionnaire and LCSS., Pharmacodynamic (PD) and possible pharmacogenetic (PG) assessments and biomarkers in blood or/and tissue sample. Biomarkers in the blood or tissue related to efficacy.
Interventions
Sponsors
Xcovery Holding Co. LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) as assessed by independent radiology review (IRR) based on RECIST v. 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy Endpoints: Overall survival, CNS response rate (based on IRR), time to CNS progression (based on IRR), objective response rate (based on IRR), PFS (based on investigator assessment), ORR (based on investigator assessment), Time to response (based on investigator assessment and IRR), Duration of response (based on investigator assessment and IRR), CNS response rate (based on investigator assessment), Time to CNS progression (based on investigator assessment), Patient reported time to deterioration (TTD) as measured by the EORTC C30/LC13 QoL questionnaire and Lung Cancer Symptom Scale (LCSS), Patient reported health-related quality of life (HRQoL) as measured by the EORTC C30/LC13 QoL questionnaire and LCSS., Pharmacodynamic (PD) and possible pharmacogenetic (PG) assessments and biomarkers in blood or/and tissue sample. Biomarkers in the blood or tissue related to efficacy. | — |
Countries
Belgium, Czechia, France, Italy, Netherlands, Poland, Spain
Outcome results
None listed