Metastatic Non-small cell lung cancer (NSCLC) and Pancreatic ductal adenocarcinoma
Conditions
Brief summary
Best overall response (BOR) based on investigator assessment per RECIST v.1.1
Detailed description
Duration of response (DOR) Clinical benefit rate (CBR) Progression-free survival (PFS) Overall survival (OS), Frequency and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) Treatment discontinuation, interruptions, and dose reductions due to any AEs Frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0, To evaluate pharmacodynamic changes, proteomic, genomic and other biomarkers that may correlate with treatment outcome To characterize mechanisms of acquired resistance correlating with treatment outcome
Interventions
DRUGDEXTROSE INJECTION / BRADEX 5%
DRUGASP3082
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response (BOR) based on investigator assessment per RECIST v.1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) Clinical benefit rate (CBR) Progression-free survival (PFS) Overall survival (OS), Frequency and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) Treatment discontinuation, interruptions, and dose reductions due to any AEs Frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0, To evaluate pharmacodynamic changes, proteomic, genomic and other biomarkers that may correlate with treatment outcome To characterize mechanisms of acquired resistance correlating with treatment outcome | — |
Outcome results
None listed