Metastatic Non-Small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SmofKabiven E
Pharmaceutical Form: Emulsion for infusion
Trade Name: Soluvit
Pharmaceutical Form: Lyophilisate for solution for infusion
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Metastatic NSCLC patient 2. Adult = 18 years 3. Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports) 4. Moderate malnutrition defined by = 5 % weight loss in the last month or = 10% in the last 6 months 5. An energy gap of = 40 % between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening 6. Functional digestive tract allowing oral intake 7. Signed informed consent from patient or legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 81 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. PN administered during the preceding month (the sole administration of intravenous glucose is allowed) 2. More than 1600 kcal/day required as PN 3. Tube feeding at screening 4. Severe malnutrition defined by = 10 % weight loss in the last month or = 15 % weight loss in the last 6 months 5. Body mass index (BMI) > 30 kg/m2 6. Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score 7. Life expectancy 353 mg/dL) 16. 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 17. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy 18. Uncontrolled hyperglycaemia 19. Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration) 20. Pregnancy or lactation 21. Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry 22. Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study 23. Prior inclusion in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show superiority in efficacy indicated by change in total body weight, of long-term PN with SmofKabiven E in addition to oral nutrition according to standard of care (test group) over oral nutrition as per standard of care alone (control group) during chemo- and/or immunotherapy.;Secondary Objective: The secondary objectives of the study are to compare the 2 treatment groups with regard to nutritional efficacy, chemo- and/or immunotherapy compliance and side effects, functional outcome, body composition, quality of life, therapy response and survival. ;Primary end point(s): The primary endpoint is the change in total body weight (kg) at the end of treatment after 9 ± 1 weeks of study treatment compared to baseline. ;Timepoint(s) of evaluation of this end point: Measure at Baseline Visit, Interim visits and Final Visit at 9 +/- 1 weeks after Baseline Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Nutritional status Body composition Functional Outcome (Karnofsky, ECOG performance status, Handgrip strength) Chemotherapy compliance Chemotherapy side effects and Fatigue determined based on records in the BFI questionnaire. Other endpoints: 3 months, 6 months overall survival and progression-free survival, Partial and complete response rates (as per RECIST v 1.1), Unplanned Hospitalization, Quality of Life (Functional Assessment of Cancer Therapy-General (FACT-G) score) ; Timepoint(s) of evaluation of this end point: Nutritional status: measured at Baseline, Interim and final visits Body composition: measured at Baseline and final visits Functional Outcome: measured at Baseline, Interim and final visits Chemotherapy compliance: measured at Baseline, Interim, final and Follow-up 1 visits Chemotherapy side effects and BFI questionnaire: measured at Baseline, Interim and final visits Other endpoints: • 3 months, 6 months overall survival and progression-free survival, Partial and complete response rates (as per RECIST v 1.1), Unplanned Hospitalization measured at final and follow-up visits • Quality of Life (Functional Assessment of Cancer Therapy-General (FACT-G) score) at baseline and follow-up visits | — |
Countries
France
Contacts
Public ContactDivisional Medical Clinical Affairs
Fresenius Kabi Deutschland GmbH
Outcome results
None listed