The effects of an oncology tailored nutritional intervention on the bioavailability and immune-activity of PD-1 immune checkpoint inhibitors in patients with lung cancer: Nutritional intervention in cancer immunotherapy (NutriCim) - NutriCim

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Efficacy of nutritional supplement on efficacy of immunotherapy in lung cancer
Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment: 50
Status: Not yet recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•Participants are eligible to be included in the study if the following criteria
•Age \> 18 years
•Patient must be willing and capable of giving written Informed Consent, and
•meeting all study requirements
•Capable of oral intake and digestion of the nutritional test product
•Subjects with cytologically confirmed Stage IV or recurrent NSCLC, who have
•not received prior systemic therapy treatment for their advanced NSCLC.
•Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or
•radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy
•was completed at least 6 months prior to the diagnosis of metastatic disease.

•Subject with an active auto\-immune disease requiring systemic treatment
•Lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or
•equivalent dose of other steroid)
•Previous allogeneic or organ transplant
•Serious concomitant systemic disorders (for example active infection,
•unstable cardiovascular disease) which in the opinion of the investigator would
•compromise the patient's ability to complete the study, or would interfere with
•the evaluation of the efficacy and safety of the study treatment
•Known positive test for hepatitis B virus or hepatitis C virus or human
•immunodeficiency virus (HIV) indicating acute or chronic infection