A Phase III Study of Pemetrexed plus Platinum Chemotherapy with or without Pembrolizumab Immunotherapy in Metastatic EGFR-Mutant Non-Small Cell Lung Cancer

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Full Title

A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy with or without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789) (WIRB)

Purpose

Pemetrexed, platinum-based chemotherapy (cisplatin and carboplatin), and pembrolizumab immunotherapy are all standard treatments for metastatic non-small cell lung cancer (NSCLC). In this study, researchers want to see if adding pembrolizumab to pemetrexed and platinum chemotherapy is more effective than pemetrexed and platinum chemotherapy alone in patients with metastatic NSCLC that contains an EGFR gene mutation and is no longer responding to EGFR-targeted therapies (such as erlotinib, afatinib, or osimertinib).

Pembrolizumab inhibits a protein that cancer cells use to evade detection by the immune system, thereby boosting the ability of the immune system to find and kill cancer cells. In this study, all patients will receive pemetrexed with either cisplatin or carboplatin. Some of the patients will also receive pembrolizumab and others will receive a placebo (inactive drug). The treatments 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 non-squamous NSCLC that is metastatic and has continued to grow despite drugs such as erlotinib, afatinib, or osimertinib.
  • At least 4 weeks must pass since the completion of prior medical treatment (2 weeks since radiation therapy) and entry into the study.
  • Patients may not have previously received chemotherapy for metastatic NSCLC nor immunotherapy.
  • 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 about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.

Protocol

19-140

Phase

III

Investigator

Co-Investigators