Metastatic Non-Small-Cell Lung Cancer
Conditions
Brief summary
ORR is defined as the proportion of patients who have a confirmed CR or PR as assessed per RECIST v1.1 by the IRC (Cohorts 1 and 2) or by the Investigator (Cohorts 3, 4 and Retreatment Cohort) from the date of LN145 infusion until disease progression or start of a new anticancer therapy.
Detailed description
•ORR (Cohorts 1 and 2), CR rate, DOR, DCR, and PFS (all cohorts) as assessed by the Investigator per RECIST v1.1, • CR rate, DOR, DCR, and PFS as assessed by IRC per RECIST v1.1 (Cohorts 1 and 2), • Overall survival (OS), • Incidence of Grade ≥3 TEAEs and SAEs per CTCAE v5.0 in all patients, • Percentage of successful LN-145 product generated from core biopsies in Cohort 3
Interventions
Sponsors
Iovance Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR is defined as the proportion of patients who have a confirmed CR or PR as assessed per RECIST v1.1 by the IRC (Cohorts 1 and 2) or by the Investigator (Cohorts 3, 4 and Retreatment Cohort) from the date of LN145 infusion until disease progression or start of a new anticancer therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| •ORR (Cohorts 1 and 2), CR rate, DOR, DCR, and PFS (all cohorts) as assessed by the Investigator per RECIST v1.1, • CR rate, DOR, DCR, and PFS as assessed by IRC per RECIST v1.1 (Cohorts 1 and 2), • Overall survival (OS), • Incidence of Grade ≥3 TEAEs and SAEs per CTCAE v5.0 in all patients, • Percentage of successful LN-145 product generated from core biopsies in Cohort 3 | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed