Lung Cancer
Conditions
Brief summary
Progression-Free Survival (PFS) rate at 6 months: Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1, at 6 months.
Detailed description
Duration of clinical benefit (DCB) as per RECIST 1.1: DCB calculated as the time (in months) from first dose of treatment to progression (or death from any cause) in patients who had a best overall response of CR, PR, or SD of ≥ 24 weeks., Overall Survival (OS): Overall Survival (OS) is calculated as the time from date of inclusion to date of death due to any cause., Response rate (ORR): rate of patients that achieve partial or complete response as best response during study induction treatment (ORR1) and rate of patients that have a further best response during maintenance treatment (ORR2).
Interventions
DRUGAUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR LYSATE
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Instituto Oncologico Dr. Rosell S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) rate at 6 months: Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1, at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of clinical benefit (DCB) as per RECIST 1.1: DCB calculated as the time (in months) from first dose of treatment to progression (or death from any cause) in patients who had a best overall response of CR, PR, or SD of ≥ 24 weeks., Overall Survival (OS): Overall Survival (OS) is calculated as the time from date of inclusion to date of death due to any cause., Response rate (ORR): rate of patients that achieve partial or complete response as best response during study induction treatment (ORR1) and rate of patients that have a further best response during maintenance treatment (ORR2). | — |
Countries
Spain
Outcome results
None listed