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

April 30, 2018 updated by: Shionogi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Cancer Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
    • New Jersey
      • East Orange, New Jersey, United States, 07108
        • VA Medical Center-East Orange (study available to veterans only)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: S-3304 plus 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
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
ACTIVE_COMPARATOR: Chemo-irradiation
The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered
Other: Chemo-irradiation
Standard of care chemo-irradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shionogi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2003

Primary Completion (ACTUAL)

September 28, 2006

Study Completion (ACTUAL)

October 26, 2006

Study Registration Dates

First Submitted

February 24, 2004

First Submitted That Met QC Criteria

February 25, 2004

First Posted (ESTIMATE)

February 26, 2004

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0207P1421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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