A Phase III Study of Etoposide/Platinum with and without Ipilimumab in Patients with Newly Diagnosed Advanced Small Cell Lung Cancer

Protocol
12-202
Full 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)
Phase
III
Purpose

Etoposide and a platinum drug (such as cisplatin or carboplatin) is the standard chemotherapy regimen for extensive-stage small cell lung cancer (SCLC), but many patients still succumb to the disease. The purpose of this study is to see if adding the drug ipilimumab to etoposide/platinum therapy is more effective than the standard therapy alone in patients newly diagnosed with advanced SCLC.

Ipilimumab is approved for treating advanced melanoma, but its use in this study is considered investigational. Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.

Patients in this study will be randomly assigned to receive etoposide/platinum therapy with ipilimumab or etoposide/platinum therapy alone.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with extensive-stage small cell lung cancer.
  • Patients may not have had prior systemic therapy (such as chemotherapy, targeted agents, immunotherapy, or vaccines) for SCLC, but prior radiation therapy or local surgery is permitted if it was completed at least 3 weeks before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. M. Catherine Pietanza at 646-888-4203.

Disease(s)
Lung Cancer
Lung Cancer, Small Cell
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