A Phase II Study of Pembrolizumab Immunotherapy plus Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib, Compared to Concurrent Chemoradiation Therapy Alone in People with Newly Diagnosed Untreated Limited-Stage Small…

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Full Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (WIRB)

Purpose

This study will assess the effects of pembrolizumab immunotherapy with concurrent chemotherapy and radiation therapy followed by pembrolizumab plus olaparib in people newly diagnosed with limited-stage small cell lung cancer (SCLC). Pembrolizumab boosts the power of the immune system to find and kill cancer cells. Olaparib prevents DNA repair in cancer cells and helps to promote cancer cell death. 

The use of pembrolizumab and olaparib for limited-stage SCLC is considered investigational. The radiation therapy and chemotherapies being used in this study (cisplatin/carboplatin and etoposide) are standard treatments for patients with this disease.

Participants in this study will be randomly assigned and equally distributed to one of three groups:

  • Pembrolizumab with chemotherapy and radiation therapy followed by pembrolizumab and a placebo (inactive drug)
  • Pembrolizumab with chemotherapy and radiation therapy followed by pembrolizumab and olaparib
  • Chemotherapy and radiation therapy plus placebos

Olaparib is taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

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

  • Participants must have newly diagnosed previously untreated limited-stage (stage I-III) 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, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Victoria Lai at 646-608-3793.

Protocol

21-259

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators