Advanced ALK-positive non-small cell lung cancer (NSCLC)
Conditions
Brief summary
Progression-free survival (PFS)
Detailed description
1) - Overall survival (OS) - Progression-free survival (PFS) per investigator assessment - Time to intracranial progression per blinded independent central review (BICR) - Intracranial objective response rate (IC-ORR) - Intracranial duration of response (IC-DOR) - Objective response rate (ORR) - Duration of response (DOR) - Time to intracranial progression, IC-ORR, IC-DOR, ORR, and DOR, 2) Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters, 3) Changes in patient-reported outcomes (PROs)
Interventions
Sponsors
Nuvalent Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) - Overall survival (OS) - Progression-free survival (PFS) per investigator assessment - Time to intracranial progression per blinded independent central review (BICR) - Intracranial objective response rate (IC-ORR) - Intracranial duration of response (IC-DOR) - Objective response rate (ORR) - Duration of response (DOR) - Time to intracranial progression, IC-ORR, IC-DOR, ORR, and DOR, 2) Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters, 3) Changes in patient-reported outcomes (PROs) | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed