Non Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of BMS-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.
Interventions
DRUGBMS-663513
mg/kg, IV, 0.3, 1,3,6,10 mg/kg, q 3 wks, 12 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* NSCLC who are eligible to receive a 6 week course of RT * Part 1 - not candidates for definitive RT * Part 2 - candidates for definitive RT
Exclusion criteria
* Severe COPD, pulmonary infection or interstitial pneumonitis * Recent cellulitis * Autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the MTD and assess safety and tolerability of single ascending doses of BMS-663513 when given in combination with radiotherapy alone or radiotherapy plus paclitaxel and carboplatin to subjects with Non Small Cell Lung Carcinoma | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Assess the PKs of BMS-663513 and the effect of BMS-663513 on immune system markers | end of study |
| Describe anti-tumor activity | throughout the study |
| Obtain blood and plasma for exploratory research | several timepoints throughout the study |
| Obtain archival tissue for predictive marker research | at screening |
Countries
United States
Outcome results
None listed