Non-small cell lung cancer
Conditions
Interventions
Thienam(R) 0g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Thienam(R) 0.5g is administered before the initial cispla
Sponsors
Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those between 20 and 70 years old 2. Those who have non-small cell lung cancer (stage 4) 3. Those who undergo an initial cisplatin-based chemotherapy 4. Those with the performance status (PS) 0 or 1 5. Those who have given written informed consent on the use of their clinical data for this study
Exclusion criteria
Exclusion criteria: 1. Those with kidney dysfunction (eGFR<60 mL/min/1.73m2) 2. Those who have diseases or symptoms considered to have an effect on the determination of efficacy or safety 3. Those who received antibiotics, antiviral drugs, or antifungal drugs (except for topical application, eye drops, or nose drops) within 14 days before enrollment 4. Those who are considered not eligible for this study by attending doctors due to any medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Cmax, T1/2, and AUC) of cisplatin under the co-administration with cilastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the absolute value and percentage of the estimated glomerular filtration rate (eGFR) 8 days after the administration of cisplatin from baseline | — |
Countries
Japan
Contacts
Public ContactMichihiro Hosojima
Kidney Research Center, Niigata University Graduate School of Medical and Dental Science Department of Clinical Nutrition Science
Outcome results
None listed