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This is an open-label study with two parts, a Phase I study and a randomized Phase II study. This study will be conducted at approximately ten sites in the United States. Approximately 178 patients will be enrolled in this trial.
Full description
Combining standard chemotherapy with a PD-1/PD-L1 inhibitor holds great appeal in the treatment of SCLC. While this approach may be appropriate for many cancer types, SCLC may be particularly vulnerable to this treatment strategy. Early studies have suggested greater efficacy with agents targeting PD-1/PD-L1 in tumors that are more mutationally complex, such as those associated with tobacco use. SCLC has a strong association with tobacco use and indeed, genome-wide sequencing studies have consistently shown that SCLC carries one of the highest rates of non-synonymous mutations. In addition, MPDL3280A has been safely combined with platinum based chemotherapy doublets in the treatment of NSCLC. Thus, a combination of carboplatin, etoposide and MPDL3280A may significantly improve outcomes in the treatment of SCLC.
Enrollment
Sex
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Volunteers
Inclusion criteria
Patients with known Gilbert disease who have serum bilirubin level 3 ULN may be enrolled.
AST and ALT 3.0 ULN with the following exception: Patients with liver involvement: AST and/or ALT 5 ULN
Alkaline phosphatase 2.5 ULN with the following exception:
Patients with liver or bone inv ULN or creatinine clearance 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation:
(140 age) (weight in kg) (0.85 if female) 72 (serum creatinine in mg/dL)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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