Extensive stage small cell lung cancer
Conditions
Brief summary
All study parts: Incidence and severity of AEs, SAEs, changes in laboratory values, vital signs, and ECGs, Incidence and nature of dose limiting toxicity (DLTs), Phase II Group A: Overall response rate (ORR) as per RECIST v1.1
Detailed description
Phase I Part A and Phase II: ORR, disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as per RECIST v1.1, Phase II Group A: DCR, DoR, and PFS as per RECIST v1.1, Phase I Part A and Phase II: Summary of CAR transgene levels by qPCR in peripheral blood (and other tissue, if available), and cellular kinetic parameters (Cmax, Tmax, AUC, Clast, and Tlast) from peripheral blood profile samples by time point
Interventions
DRUGBENDAMUSTINE HYDROCHLORIDE
DRUGCYCLOPHOSPHAMIDE
DRUGDJI136
DRUGFLUDARABINE PHOSPHATE
DRUGTOCILIZUMAB
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All study parts: Incidence and severity of AEs, SAEs, changes in laboratory values, vital signs, and ECGs, Incidence and nature of dose limiting toxicity (DLTs), Phase II Group A: Overall response rate (ORR) as per RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Part A and Phase II: ORR, disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as per RECIST v1.1, Phase II Group A: DCR, DoR, and PFS as per RECIST v1.1, Phase I Part A and Phase II: Summary of CAR transgene levels by qPCR in peripheral blood (and other tissue, if available), and cellular kinetic parameters (Cmax, Tmax, AUC, Clast, and Tlast) from peripheral blood profile samples by time point | — |
Outcome results
None listed