Lung Cancer, Non Small Cell Lung Cancer, Stage IIIA Non Small Cell Lung Cancer, Stage IIIB Non Small Cell Lung Cancer
Conditions
Keywords
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, type IV collagenases, Unresectable locally advanced non-small cell lung cancer
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.
Interventions
DRUGS-3304
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
OTHERChemo-irradiation
Standard of care chemo-irradiation
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed