Clinical Trial VICCTHN1189
Title
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum in Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Principal Investigator(s)
Details
- Protocol No. VICCTHN1189
- Open Date: 12/14/2012
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To compare overall survival (OS) of subjects randomized to ipilimumab in addition to platinum and etoposide (Arm A) to that of subjects randomized to placebo in addition to platinum and etoposide (Arm B) in subjects with newly diagnosed extensive stage SCLC.
- Disease Sites: Lung; Small Cell
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Carboplatin; Cisplatin; Etoposide; Ipilimumab
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01450761
- Secondary Protocol No: CA184156
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Exclusion Criteria:
• Prior systemic therapy for lung cancer
• Symptomatic Central Nervous System (CNS) metastases
• History of autoimmune disease
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