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Page last updated: 4/15/2020

An adaptive phase 3, randomized, open-label, controlled study evaluating bintrafusp alfa versus pembrolizumab in the first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC) that has high expression of PD-L1.*




ClinicalTrials.gov: NCT03631706

Location: Global

Countries: Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Netherlands, Spain, Taiwan, Turkey, Ukraine, and the United States


Now enrolling

Find a trial site near you at www.clinicaltrials.gov

Key inclusion criteria

  • Participants must have histologically confirmed advanced NSCLC and PD-L1 -high* tumor expression. Participants must not have received prior systemic therapy for their stage IV NSCLC 

Key exclusion criteria

  • Participants must not have nonsquamous NSCLC histologies with tumors containing an EGFR-sensitizing (activating) mutation, ALK translocation, ROS1 rearrangement, or BRAF V600E mutation if targeted therapy is locally approved
Study Design | Global

Are you interested and want to know if this trial is right for you or someone you know?

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Speak with a doctor before making a decision regarding whether a clinical trial is the right option.

Bintrafusp alfa is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for bintrafusp alfa, and it includes information about how the trial is structured and how Merck Healthcare KGaA will determine whether bintrafusp alfa might be safe or effective. Therefore, it is important to understand that bintrafusp alfa is not a treatment or therapy for cancer or any other disease, and it has not been approved to be used by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.

You should speak with your doctor, who can help you decide whether a clinical trial might be right for you. Your doctor will be able to answer questions you might have about the risk of participating in a trial, and what other options may be available to you.

* PD-L1 -high expression as determined by central testing. 

† For a full list of inclusion and exclusion criteria, please visit https://www.clinicaltrials.gov

1L, first-line; ALK, anaplastic lymphoma kinase; BOR, best overall response; BRAF, B-Raf proto-oncogene, serine/threonine kinase; DOR, duration of response; EGFR, epidermal growth factor receptor; IHC, immunohistochemistry; IV, intravenous; NSCLC, non-small cell lung cancer; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; Q2W, every 2 weeks; Q3W, every 3 weeks; R, randomized; ROS1, ROS proto-oncogene 1.


ClinicalTrials.gov. M7824 versus pembrolizumab as a first-line (1L) treatment in participants with programmed death-ligand 1 (PD-L1) expressing advanced non-small cell lung cancer (NSCLC). https://clinicaltrials.gov/ct2/show/NCT03631706. Accessed April 15, 2020.


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