EUCTR2016-001692-67-ESActive, not recruitingPhase 1
A Phase 1/2 Randomized Trial of BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer
Bristol-Myers Squibb International Corporation0 sites160 target enrollmentStarted: July 15, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Pulmonary SCLC documented by histology or cytology
- •- Extensive disease (Stage IV) Small Cell Lung Cancer
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- Male and Females 18 years of age or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
Exclusion Criteria
- •- Prior systemic therapy for lung cancer
- •- Symptomatic brain metastases
- •- Grade 2 peripheral neuropathy
- •- Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •- Other active malignancies or prior malignancy within 2 years
Investigators
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