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

Tracking Information
First Received Date ^ICMJE	February 24, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE	February 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00078390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official Title ^ICMJE	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.
Brief 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.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Non Small Cell Lung Cancer Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Non Small Cell Lung Cancer
Intervention ^ICMJE	Drug: S-3304
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	90
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion ECOG performance status 0-1 adequate organ function clinically indicated and able to receive conventional chemoradiation therapy EXCLUSION CRITERIA patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00078390
Responsible Party
Study ID Numbers ^ICMJE	0207P1421
Study Sponsor ^ICMJE	Shionogi
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Shionogi
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP