Spots Global Cancer Trial Database for Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Official Title: Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

Study ID: NCT00441740

Conditions

Non Small Cell Lung Cancer

Interventions

Study Description

Brief Summary: The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Detailed Description: Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.