NCT00078390

Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-small Cell Lung Cancer.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

Detailed description

A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Conditions

• Non Small Cell Lung Cancer
• Lung Cancer
• Stage IIIA Non Small Cell Lung Cancer
• Stage IIIB Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	S-3304	S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
OTHER	Chemo-irradiation	Standard of care chemo-irradiation

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-09-28
• Completion: 2006-10-26
• First posted: 2004-02-26
• Last updated: 2018-05-02

Locations

5 sites across 1 country: United States