advanced ALK-positive non-small cell lung cancer
Conditions
Brief summary
Progression-Free Survival (PFS) at 12 months as determined by investigator assessment
Detailed description
PFS at 12 months as determined by independent review, Confirmed Overall Response Rate (ORR) as determined by investigator assessment and by independent review, Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), PFS at 12 months in sub-populations as determined by investigator assessment and independent review, ORR in sub-populations as determined by investigator assessment and independent review, Confirmed Intracranial ORR as determined by investigator assessment and by independent review, Intracranial PSF at 12 months, Time until definitive HRQoL score deterioration using EORTC QLQC30/ QLQ-LC13 questionnaire, Duration of Response (DOR) as determined by investigator assessment and by independent review, Disease Control Rate (DCR) as determined by investigator assessment and by independent review, Overall Survival (OS), Duration of intracranial response (CNS DOR) as determined by investigator assessment and by independent review, Intracranial DCR as determined by investigator assessment and by independent review
Interventions
DRUGPemetrexed Viatris 25 mg/ml
DRUGsolution à diluer pour perfusion
Sponsors
Intergroupe Francophone De Cancerologie Thoracique
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) at 12 months as determined by investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS at 12 months as determined by independent review, Confirmed Overall Response Rate (ORR) as determined by investigator assessment and by independent review, Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), PFS at 12 months in sub-populations as determined by investigator assessment and independent review, ORR in sub-populations as determined by investigator assessment and independent review, Confirmed Intracranial ORR as determined by investigator assessment and by independent review, Intracranial PSF at 12 months, Time until definitive HRQoL score deterioration using EORTC QLQC30/ QLQ-LC13 questionnaire, Duration of Response (DOR) as determined by investigator assessment and by independent review, Disease Control Rate (DCR) as determined by investigator assessment and by independent review, Overall Survival (OS), Duration of intracranial response (CNS DO | — |
Countries
France
Outcome results
None listed