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

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer; Lung Cancer; Stage IIIA Non Small Cell Lung Cancer; Stage IIIB Non Small Cell Lung Cancer
• Interventions: Drug: S-3304; Other: Chemo-irradiation

• Registration Number: NCT00078390
• Lead Sponsor: Shionogi

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2004-02-24
• Study First Submitted QC: 2004-02-25
• Study First Posted: 2004-02-26
• Primary Completion: 2006-09-28
• Study Completion: 2006-10-26
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-3304 plus chemo-irradiation	S-3304	The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy
S-3304 plus chemo-irradiation	Chemo-irradiation	The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy
Chemo-irradiation	Chemo-irradiation	The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered

Trial Locations

Locations (5)

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Scripps Cancer Institute; 🇺🇸 La Jolla, California, United States

University of Kansas Cancer Center; 🇺🇸 Kansas City, Kansas, United States

VA Medical Center-East Orange (study available to veterans only); 🇺🇸 East Orange, New Jersey, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States