drugset / Trial / NCT01194453

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

NCT01194453 ↗

Phase 2 Completed 288 enrolled Sun Yat-sen University
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

EvaluationDrugModalityDoseRoute
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