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A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-002688-26

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and stage IV Non-Small Cell Lung Cancer (NSCLC)

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Extrait

The objectives of this phase III study are to compare the efficacy and safety of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line treatment of patients with stage IIIB (with effusion) or Stage IV NSCLC. The primary efficacy objective is to compare overall survival (OS) in NSCLC patients with non-squamous cell carcinoma histology treated with gemcitabine, cisplatin and sorafenib to patients treated with gemcitabine, cisplatin and placebo.

Critère d'inclusion

  • The patient population includes patients with Stage IIIB (with effusion) or Stage IV NSCLC of non-squamous cell carcinoma subtype, with ECOG performance status 0 or 1, for whom treatment with gemcitabine and cisplatin is considered medically acceptable. Patients must have measurable disease and must not have received prior systemic anticancer therapy

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