The effect of extra hydration on kidney function during carboplatin-pemetrexed-pembrolizumab in patients with advanced non-small cell lung cancer.;*Hydration to prevent nephrotoxicity due to pemetrexed (HydraPem Study)*
- Conditions
- kidney injurynephrotoxicity1003866610038430
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 118
Age > 18 years
Patients must be willing and capable of giving written informed consent
Patients with advanced non-squamous cell lung cancer, receiving first line
treatment with pemetrexed/pembrolizumab maintenance after
carboplatin/pemetrexed/pembrolizumab.
ECOG 0-2
Adequate hematological, renal and liver functions.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoints are a decline in kidney function (AKD) based on: eGFR < 60<br /><br>mL.min-1 per 1.73m2 for < 3 months, or decrease in eGFR by > 35 or increase in<br /><br>serum creatinine >50% for <3 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>TIme to occurence of AKD<br /><br>Rate of decline kidney function (eGFR)<br /><br>Treatment dose intensity, including number of dose reductions</p><br>