This trial is active, not recruiting.

Conditions non small cell lung cancer, lung cancer, stage iiia non small cell lung cancer, stage iiib non small cell lung cancer
Treatment s-3304
Phase phase 1/phase 2
Sponsor Shionogi
Start date February 2003
Trial size 90 participants
Trial identifier NCT00078390, 0207P1421


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official 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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Shionogi.