臨床研究等提出・公開システム

Verification study for stratification marker of immune checkpoint inhibitor in patients with advanced or recurrent non-small cell lung cancer

Stratification marker for immunotherapy in lung cancer

Sasada Tetsuro

Kanagawa Cancer Center

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan

tsasada@kcch.jp

Sasada Tetsuro

Kanagawa Cancer Center

2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa 241-8515, Japan

+81-45-520-2222

tsasada@kcch.jp

Recruiting

Mar. 29, 2022

Observational

1)Patients with pathologically or cytologically diagnosed, advanced (Stage III or IV)or recurrent non-small-cell lung cancer
2)Patients scheduled to receive anti-PD-1/PD-L1 antibody treatment with or without combination chemotherapy or anti-CTLA-4 antibody treatment
3)Patients over 20 years old with written informed consent
4) Patients with ECOG PS 0-2
5)Patients with measurable target lesions for response evaluation with RECIST(Ver1.1)
6)Patients expected to survive more than 12 weeks after treatment initiation.

1)Patients with the past history of immunological treatments (anti-PD-1/PD-L1 antibody therapy, anti-CTLA-4 antibody therapy, cancer vaccines, or immune cell therapy)
2)Patients with regular use of amino acid formulations (as intravenous or enteral nutrition) or supplements, excluding anamorelin
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 on novel anti-cancer agents or treatment regimens
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 who have brain metastases with clinical symptoms and require administration of corticosteroids (at doses equivalent to, or exceeding, prednisolone 5 mg daily) or antihydropic
7)Patients with poorly controlled pleural effusion, ascites, or pericardial effusion
8)Patients with severe infections or complications
9)Patients with other inappropriate conditions for enrollment judged by the clinicians

Both

Non-Small Cell Lung Cancer

none

Evaluation of overall survival between good and poor subgroups by multivariate discriminant models (3 types) in patients treated with anti-PD-1/PL-L1 antibody with combined chemotherapy (cohort A).

1) Evaluation of overall survival between subgroups startefied by multivariate discriminant models, which are establised for predicting the effects of combined chamotherapy, in patients treated with anti-PD-1/PL-L1 antibody with (cohort A) or without (cohort B) combinaed chemotherapy
2) Evaluation of the effects of various factors on overall survival prediction by multivariate discriminant models

+81-45-520-2222

Mar. 14, 2022

No

none