# 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)

> **NCT00449033** · PHASE3 · COMPLETED · sponsor: **Bayer** · enrollment: 904 (actual)

## Conditions studied

- Carcinoma, Non-Small-Cell Lung

## Interventions

- **DRUG:** Sorafenib (Nexavar, BAY43-9006)
- **DRUG:** Placebo
- **DRUG:** Gemcitabine
- **DRUG:** Cisplatin

## Key facts

- **NCT ID:** NCT00449033
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-02
- **Primary completion:** 2010-04
- **Final completion:** 2011-06
- **Target enrollment:** 904 (ACTUAL)
- **Last updated:** 2015-04-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00449033

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00449033, "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)". Retrieved via AI Analytics 2026-07-12 from https://api.ai-analytics.org/clinical/NCT00449033. Licensed CC0.

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