Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1
Detailed description
-Duration of Response (DoR), - Progression-free Survival (PFS), - Objective Response Rate (ORR), - Disease Control Rate (DCR), - Time to Response (TTR), - Best percentage change in the sum of diameters (SoD) of measurable tumors, - Overall Survival (OS), - Safety parameters (AEs, ECOG PS, vital signs, clinical laboratory parameters, ECG etc.), - Correlation between HER3 protein expression and efficacy, - Anti-drug antibody (ADA) status at baseline and post-baseline.
Interventions
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Duration of Response (DoR), - Progression-free Survival (PFS), - Objective Response Rate (ORR), - Disease Control Rate (DCR), - Time to Response (TTR), - Best percentage change in the sum of diameters (SoD) of measurable tumors, - Overall Survival (OS), - Safety parameters (AEs, ECOG PS, vital signs, clinical laboratory parameters, ECG etc.), - Correlation between HER3 protein expression and efficacy, - Anti-drug antibody (ADA) status at baseline and post-baseline. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed