Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients

Inclusion Criteria:

* Age above or equal to 18 years, and below 75 years;
* Diagnosis of metastatic or recurrent NSCLC, beginning second-line palliative mono-chemotherapy treatment;
* Functional capacity (ECOG-PS) grade 0 - 2;
* Adequate hematological, kidney and liver function, as follows:

  * Total neutrophil count ≥ 1500/μL
  * Platelet count ≥ 100.000/μL
  * Hemoglobin ≥ 9 g/dL
  * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
  * Patients with confirmed Gilbert's syndrome and serum bilirubin ≤ 3 × ULN
* Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min based on the Cockcroft-Gault equation:

  (140 - age) × (weight in Kkg) × (0.85) 72 × (serum creatinine in mg/dL)
* Absence of any emotional, family-related, sociological, or geographic condition that can potentially hamper adherence to the study protocol and the follow-up schedule;
* Capacity and willingness to adhere to the study visits and tests, and to adhere to the protocol, according to the researcher's evaluation.

Exclusion Criteria:

* Tube feeding, gastrostomy- or jejunostomy;
* Uncontrollable vomiting;
* Sexually active women of reproductive age, except for those who underwent surgical sterilization (e. g., tubal ligation);
* Intestinal obstruction or sub-obstruction;
* Known allergy to any of the components of the investigational product;
* Malabsorption syndrome or other condition that could interfere with enteric absorption;
* History of inflammation of the small or large intestine, previous or currently active (such as Crohn's disease or ulcerative colitis);
* Chronic diarrhea of any cause;
* Diagnosis of any chronic disease that, in the researcher's opinion, will interfere with the participation in the study;
* Known diagnosis of HIV -infection;
* Diagnosis of any chronic disease that changes the immune system and significantly increases the risk of infection;
* The need to use G-CSF already in the first chemotherapy cycle;
* Severe neuropsychiatric disease that prevents the patient from completing the study questionnaires, determined at the researcher's discretion.