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.
1 other identifier
interventional
9
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2003
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 24, 2004
CompletedFirst Posted
Study publicly available on registry
February 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2006
CompletedMay 2, 2018
April 1, 2018
3.7 years
February 24, 2004
April 30, 2018
Conditions
Keywords
Study Arms (2)
S-3304 plus chemo-irradiation
EXPERIMENTALThe 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
ACTIVE COMPARATORThe standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered
Interventions
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
Standard of care chemo-irradiation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shionogilead
Study Sites (5)
Scripps Cancer Institute
La Jolla, California, 92037, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
VA Medical Center-East Orange (study available to veterans only)
East Orange, New Jersey, 07108, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2004
First Posted
February 26, 2004
Study Start
February 1, 2003
Primary Completion
September 28, 2006
Study Completion
October 26, 2006
Last Updated
May 2, 2018
Record last verified: 2018-04