Stratification marker for immunotherapy in lung cancer

JRCT ID: jRCT1031190196

Registered date:28/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 07/02/2020
• Target sample size: 100
• Study type: Observational
• Intervention(s): None

Outcome(s)

• Primary Outcome: 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 Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Sasada Tetsuro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development