A Phase III Study of Standard Chemotherapy plus Pembrolizumab Immunotherapy or Placebo to Treat Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

Full Title

604-02: A Phase III Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects with Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

Purpose

Etoposide plus cisplatin or carboplatin is a standard chemotherapy combination for extensive-stage small cell lung cancer (SCLC). However, the cancer often continues to grow despite this therapy. In this study, researchers want to see if adding the immunotherapy drug pembrolizumab to standard chemotherapy is more effective than chemotherapy alone in patients newly diagnosed with extensive-stage SCLC.

Pembrolizumab enhances the immune system’s ability to find and destroy cancer cells. It works by blocking PD-1, a protein that cancer cells use to evade detection by the immune system.

Patients in this study will receive etoposide and either cisplatin or carboplatin, plus either pembrolizumab or a placebo (inactive medication). All of these therapies are given intravenously (by vein).

Eligibility

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

  • Patients must have newly diagnosed, previously untreated extensive-stage (stage IV) SCLC.
  • 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 for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Charles Rudin at 646-888-4336.

Protocol

17-334

Phase

III

Investigator

Co-Investigators