Hydrapem

The effect of extra hydration on kidney function during carboplatinpemetrexed-pembrolizumab in patients with advanced non-small cell lung cancer.

• 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
  • Subjects with advanced stage non-squamous cell lung cancer, receiving first line treatment with induction carboplatinum/pemetrexed / pembrolizumab and subsequently pemetrexed/pembrolizumab maintenance therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Adequate haematological, renal and liver function

1. Adequate hematological function:

• • Hemoglobin ≥90 g/L or ≥5.6 mmol/L
  • WBC ≥1.0× 109/L
  • Lymphocytes ≥0.5 g/L
  • Absolute neutrophil count (ANC) ≥1.5× 109/L
  • Platelet count ≥100× 109/L

2. Renal function:

• • Calculated creatinine clearance ≥45 mL/min/1.73m2 (CKD-EPI)

3. Adequate liver function:

• ALT and AST ≤2.5× ULN. If the patient has liver metastases, ALT and AST must be ≤5× ULN
• Total serum bilirubin ≤1.5× ULN. If the patient has liver metastases or documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) ≤3× ULN.

• 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 another steroid)
• Previous allogeneic or organ transplant
• Known heart failure
• Myocardial infarction previous 6 months
• 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
• Moderate to severe hypercalcemia, i.e. total calcium level corrected for albumin ≥12.0 mg/dL (3.0 mmol/L)
• Simultaneous participation in other clinical trial
• Pregnant or lactating women