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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2004 by Shionogi.
Recruitment status was:  Active, not recruiting
Information provided by:
Shionogi Identifier:
First received: February 24, 2004
Last updated: June 23, 2005
Last verified: December 2004
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.

Condition Intervention Phase
Non Small Cell Lung Cancer
Lung Cancer
Stage IIIA Non Small Cell Lung Cancer
Stage IIIB Non Small Cell Lung Cancer
Drug: S-3304
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Shionogi:

Estimated Enrollment: 90
Study Start Date: February 2003
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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00078390

United States, California
Scripps Cancer Institute
La Jolla, California, United States, 92037
United States, District of Columbia
Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, New Jersey
VA Medical Center-East Orange (study available to veterans only)
East Orange, New Jersey, United States, 07108
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
  More Information Identifier: NCT00078390     History of Changes
Other Study ID Numbers: 0207P1421
Study First Received: February 24, 2004
Last Updated: June 23, 2005

Keywords provided by Shionogi:
Lung cancer
Lung carcinoma
Non small cell lung cancer
Stage IIIA non small cell lung cancer
Stage IIIB non small cell lung cancer
Unresectable locally advanced non-small cell lung cancer
Stage III
matrix metalloproteinases
type IV collagenases

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
S 3304
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017