Stratification marker for immunotherapy in lung cancer

JRCT ID: jRCT1031210706

Registered date:29/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 29/03/2022
• Target sample size: 150
• Study type: Observational
• Intervention(s): none

Outcome(s)

• Primary Outcome: 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).

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Sasada Tetsuro