Clinical Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects
Phase 2
- Conditions
- on-Small-Cell Lung Carcinoma
- Registration Number
- JPRN-jRCT2080221239
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Subjects must have recurrent, metastatic or progressive NSCLC
Pathologically confirmed NSCLC
Previously received treatment with single agent Gefitinib or Erlotinib
Any one of the following:
- A tumor that harbors an EGFR mutation
- Objective clinical benefit from treatment with Gefitinib or Erlotinib
- Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease within 3 months of study enrollment
Exclusion Criteria
- Symptomatic brain metastasis
- Adequate organ function and performance status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To estimate objective response rate of BMS-690514 in NSCLC subjects
- Secondary Outcome Measures
Name Time Method - To estimate progression free survival of BMS-690514<br>- To evaluate safety and tolerability of BMS-690514