Non-Small Cell Lung Cancer
Conditions
Interventions
None
Sponsors
Sasada Tetsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically or cytologically diagnosed, advanced or recurrent, non-small-cell lung cancer, who are treated with anti-PD-1/PL-L1 antibody (in combination with or without chemotherapies or anti-CTLA4 antibody) 2) Patients over 20 years old with written informed consent 3) Patients with ECOG PS 0-2 4) Patients with measurable target lesions for response evaluation with RECIST(Ver1.1)
Exclusion criteria
Exclusion criteria: 1) Patients with the past history of immunological treatments (immune checkpoint inhibitors, cancer vaccines, or immune cell therapies) 2) Patients with regular use of amino acid formulations (as intravenous or enteral nutrition) or supplements 3) Patients with presumed abnormalities of amino acid metabolism, such as liver cirrhosis, renal failure, inborn error of amino acid metabolism, pregnancy, and feeding 4) Patients enrolled in other clinical trials for pharmaceuticals or medical devices 5) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment] 6) Patients with other inappropriate conditions for enrollment judged by the clinicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting anti-tumor responses (evaluated by RECIST Ver.1.1) in patients treated with anti-PD-1/PL-L1 antibody (all cases or subgroups) | — |
Secondary
| Measure | Time frame |
|---|---|
| Multivariate discriminant models created by combination of plasma amino acid and/or metabolite concentrations, which are useful for predicting progression free survival in patients treated with anti-PD-1/PL-L1 antibody (all cases or subgroups) | — |
Contacts
Public ContactTetsuro Sasada
Kanagawa Cancer Center
Outcome results
None listed