drugset / Trial / NCT01003964

Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

NCT01003964 ↗

Phase 2 Completed 289 enrolled National Cancer Center, Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this randomized phase II study is to compare the Response Rate of each sequence of treatment approach in patients with advanced NSCLC. Additionally, development of gene expression profiles and genotypes that can predict response to commonly used chemotherapy may provide a unique opportunity to better utilize drugs shown to be effective in first- or second-line therapy. Here, the investigators will conduct a pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents) sensitivity and demonstrating the clinical value of identifying the most appropriate drug on the basis of sensitivity profile for the treatment regimen of each individual patient. Such an approach is likely to maximize response to chemotherapy and may change the current empirical paradigm of NSCLC therapy.

Timeline

Start
2009-02
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 30 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Irinotecan Small molecule 65 mg/m2 Intravenous