A Phase III Study of Chemotherapy with or without Pembrolizumab Immunotherapy in Patients with Operable Non-Small Cell Lung Cancer

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Full Title

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Purpose

The purpose of this study is to see if adding the immunotherapy drug pembrolizumab to standard chemotherapy before surgery in patients with operable non-small cell lung cancer (NSCLC) is more effective than standard presurgical chemotherapy alone. Pembrolizumab works by activating the immune system and increasing the chance that it will detect and destroy cancer cells.

Patients in this study will be randomly assigned to one of two treatment groups:

  • Standard chemotherapy plus pembrolizumab before lung cancer surgery, followed by pembrolizumab alone after surgery.
  • Standard chemotherapy plus a placebo (inactive drug) before lung cancer surgery, followed by placebo after surgery.

Some patients may be advised by their doctor to receive radiation therapy after surgery. Pembrolizumab and the chemotherapy used in this study 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 previously untreated stage IIB or IIIA NSCLC that can be removed by surgery.
  • Patients must be medically fit for surgery.
  • Patients must be able and willing to receive chemotherapy with cisplatin.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jamie Chaft at 646-888-4545 or Dr. Matthew Bott at 212-639-5944.

Protocol

19-199

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator