NCT00532025

Sorafenib in Resected Non-small Cell Lung Carcinoma

A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-small Cell Lung Carcinoma (NSCLC) in Patients Not Eligible for Cisplatin-based Adjuvant Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC. The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. For sample size calculation a 2 year PFS of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated for the intervention group. These estimates are based on the actual PFS and overall survival (OS) of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to published international results, and the improvement of PFS achieved by 4 cycles of cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Sorafenib	Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-09-19
• Last updated: 2009-07-28

Locations

6 sites across 1 country: Germany