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Clinical Trials

Topic   Small-Cell Lung Cancer
Title   A Phase III, Randomized, Multicenter, Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients with Extensive Disease (St
Summary   Immunotherapy can help intensify the body’s immune system to detect and attack the cancer. This is a phase 3 study to determine the efficacy and safety of combining two immunotherapy drugs Durvalumab ± Tremelimumab with platinum based chemotherapy Etoposide plus Carboplatin or Cisplatin (EP) followed by Durvalumab ± Tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer. The purpose of this study is to see if combining the new anti-cancer drug Durvalumab by itself or with Tremelimumab together with EP will work better than EP alone as a first line treatment for patients with Small-Cell Lung Cancer. It will also determine whether these drugs cause any side effects and compare them to EP.
Description   Durvalumab and Tremelimumab are both intravenous immunotherapies used to treat several types of cancer. Your immune system helps protect and fight off diseases. Immunotherapy is a treatment that uses specific parts of the immune system to fight cancer. Immunotherapy enhances the body’s immune system. Cancers have to ability to disrupt the body’s normal immune functions, thereby escaping the body’s immune system. Participants will be randomly assigned to one of these three possible treatment arms: Durvalumab + Tremelimumab + EP (Arm 1), Durvalumab + EP (Arm 2), or EP (Arm 3).
IRB Number   20170149
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following:
  • This study is for patients age 18 and older.
  • 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. For example, patients must be well enough that they would be able to carry out office work or light housework.
  • Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-seizure medication for at least 1 month prior to study treatment.
  • Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
  • Life expectancy ≥12 weeks
  • ECOG 0 or 1 at enrollment.
  • No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
  • Must have a archival/ diagnostic tumor sample <3 years old
Status   Open
Start Date   05/18/2017
Principal Name   Jeffrey Schneider, MD
Contact Name   Dawn Tsushima, RN
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-4895
Alternate Phone   516-663-8391