Completed

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.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

S-3304

+ Chemo-irradiation

DrugOther
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: February 2003
See protocol details

Summary

Principal SponsorShionogi
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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. 
NCT00078390
Principal SponsorShionogi
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Group II

Active Comparator
The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Scripps Cancer Institute

La Jolla, United StatesSee the location
Suspended

Lombardi Cancer Center

Washington, United States
Suspended

University of Kansas Cancer Center

Kansas City, United States
Suspended

VA Medical Center-East Orange (study available to veterans only)

East Orange, United States
Completed5 Study Centers