Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy

Efficacy of Long-term Parenteral Nutrition With SmofKabiven® E Concomitant to Chemo- and/or Immunotherapy: A Prospective, Randomised, Controlled, Open, Multicentre, Two-stage, Adaptive Clinical Trial in Metastatic Non-small Cell Lung Cancer

The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.

Inclusion Criteria:

• Metastatic non-small cell lung cancer patient
• Adult ≥ 18 years
• Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports), or receiving the 2nd cycle of aforementioned anticancer treatment
• An energy gap of ≥ 40 % and/or 1000 kcal between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening, irrespective of weight loss
• Functional digestive tract allowing oral intake
• If female of childbearing potential, willing to use a sufficiently safe contraception method throughout participation in the study
• Signed informed consent from patient or legal representative

Exclusion Criteria:

• Parenteral nutrition (PN) administered during the preceding month (the sole administration of intravenous glucose is allowed), or standard of care PN planned to start within 3 weeks after baseline visit
• More than 1600 kcal/day required as PN
• Tube feeding at screening, or planned to start within 3 weeks after baseline visit
• Body mass index (BMI) > 30 kg/m2
• Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score
• Life expectancy < 3 months
• Active bloodstream infection demonstrated by positive blood culture at Screening
• Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
• Severe blood coagulation disorders
• Congenital errors of amino acid metabolism
• Pathologically elevated serum levels of any of the included electrolytes
• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
• Hemophagocytotic Syndrome
• Severe hyperlipidemia (serum triglycerides > 353 mg/dL)
• Severe liver insufficiency: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or conjugated bilirubin exceeding 3 x upper limit of normal range, or International Normalised Ratio (INR) > 2
• Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy
• Uncontrolled hyperglycaemia
• Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
• Pregnancy or lactation
• Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
• Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
• Prior inclusion in the present study