drugset / Trial / NCT01742767
Cisplatinum/Pemetrexed Versus Split-dose Cisplatinum/Pemetrexed In NSCLC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |