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) *

• Conditions: Efficacy of nutritional supplement on efficacy of immunotherapy in lung cancer; 10038666

• Registration Number: NL-OMON51244
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Participants are eligible to be included in the study if the following criteria
apply:
• 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.

Exclusion Criteria

• 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
• Allergy to cow*s milk protein, soy or fish, requiring a fibre-free diet or
suffering galactosemia or lactose intolerance
• Moderate to severe hypercalcemia, i.e. total calcium level corrected for
albumin >=142.0 mg/dL (3.05 mmol/L )
• Patient has had other malignancies within the past 3 years , except for
stable non-melanoma skin cancer, fully treated and stable early stage prostate
cancer or carcinoma in situ of the cervix or breast without need of treatment
• Simultaneous participation in other clinical trial
• Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified