Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT05902260
Eligibility Criteria:
Inclusion criteria:
* 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.
* Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Measurable disease by CT per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
* Adequate haematological, renal and liver function
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 ≥14.0 mg/dL (3.5 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05902260
Study Brief:
Protocol Section:
NCT05902260