drugset / Trial / NCT01194453
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-09
- Completion
- 2012-08
Outcome
Missed primary endpoint
paper Based on the Full Analyses Set (FAS), the PFS was 168 days (5.6 months) vs 140 days (4.7 months) (P=0.16) PMID 23075681 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 3.75 mg | Oral |
| Background | Vitamin B12 | Other / unclassified | 1000 ug | Other |
| Background | folic acid | Other / unclassified | 1000 ug | Oral |