Study of S-3304 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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Metaplasia Neoplasms Neoplasms by Site Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IIIA Non Small Cell Lung Cancer Stage IIIB Non Small Cell Lung Cancer Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scripps Cancer Institute, La Jolla, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-3304

Drug

S-3304 will be administered at the tolerable dose BID along with chemo-irradiation

Chemo-irradiation

Other

Standard of care chemo-irradiation

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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.

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Feb 26, 2004
Registry last updated: May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed