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

Study Overview
=================
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.

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.

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.

Conditions
-----------------
Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: S-3304
* Other: Chemo-irradiation


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner. The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-3304 plus chemo-irradiation<br>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<br>* S-3304 will be administered at the tolerable dose BID along with chemo-irradiation<br>Other: Chemo-irradiation<br>* Standard of care chemo-irradiation<br>|
| Active Comparator: Chemo-irradiation<br>The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered | Other: Chemo-irradiation<br>* Standard of care chemo-irradiation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type IV collagenases, Lung cancer, Lung carcinoma, Non small cell lung cancer, Stage IIIA non small cell lung cancer, Stage IIIB non small cell lung cancer, NSCLC, Stage III, chemotherapy, radiation, chemoradiation, matrix metalloproteinases, neovascularization, antiangiogenesis, Unresectable locally advanced non-small cell lung cancer