drugset / Trial / NCT01742767

Cisplatinum/Pemetrexed Versus Split-dose Cisplatinum/Pemetrexed In NSCLC

NCT01742767 ↗

Parallel-groupTreatment

Summary

Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity profiles and generally with an excellent patient compliance.

Timeline

Start
2012-11
Primary completion
2014-05
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 40 mg/m2 —
Subject Cisplatin Other / unclassified 75 mg/m2 —
Subject Pemetrexed Small molecule 500 mg/m2 —