A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Summary

A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

Timeline

Start

2006-02

Primary completion

2007-10

Completion

2009-02

Outcome

Missed primary endpoint

Stopped: “Based on the results of the interim analysis, it was determined that the study would not meet its primary efficacy endpoint and the study was terminated early.”

registry analysis (superiority or other test); Sorafenib + C/P vs Placebo + C/P; p = 0.915; Hazard Ratio (HR) 1.15 (95% CI 0.94 to 1.41); Log Rank; NCT00300885 ↗

paper The study was terminated after the interim analysis concluded that the study was highly unlikely to meet its primary end point. PMID 20212250 ↗

Publications

• Results Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	400 mg	Oral
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous

Indications