Metastatic non-small cell lung cancer (NSCLC)
Conditions
Brief summary
Stage 1 1. Objective response rate (ORR)
Detailed description
Stage 1 1. PFS, Stage 1 2. PFS at specific time points, Stage 1 3. OS, Stage 1 4. OS at specific time points, Stage 1 5. DOR, Stage 1 6. DCR, Stage 1 and 2 7. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 8. Change from baseline in vital signs, electrocardiogram parameters and targeted clinical laboratory test results
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 1. Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage 1 1. PFS, Stage 1 2. PFS at specific time points, Stage 1 3. OS, Stage 1 4. OS at specific time points, Stage 1 5. DOR, Stage 1 6. DCR, Stage 1 and 2 7. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0, Stage 1 and 2 8. Change from baseline in vital signs, electrocardiogram parameters and targeted clinical laboratory test results | — |
Countries
France, Spain
Outcome results
None listed