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Page last updated: 4/22/2020

A phase 2, randomized, controlled study evaluating bintrafusp alfa with concurrent chemoradiation (cCRT) followed by bintrafusp alfa versus placebo with cCRT followed by durvalumab for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC).

STAGE III

PHASE 2
RANDOMIZED

COMBINATION
THERAPY


ClinicalTrials.gov: NCT03840902

Location: Global

Countries: Japan, Spain, and the United States

Status:

Now Enrolling

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


Key inclusion criteria*


  • Participants must have histologically documented stage III, locally advanced, unresectable NSCLC and adequate pulmonary function

Key exclusion criteria*


  • Participants must not have mixed small cell with NSCLC histology or have received prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell co-regulatory proteins
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 to 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 EMD Serono, a business of Merck KGaA, Darmstadt, Germany, 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.

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

cCRT consists of intensity modulated radiation therapy in combination with chemotherapy (cisplatin/etoposide, cisplatin/pemetrexed, or carboplatin/paclitaxel).

cCRT, concurrent chemoradiation; DOR, duration of response; IV, intravenous; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q2W, every 2 weeks; R, randomized.

References

ClinicalTrials.gov. M7824 with cCRT in unresectable stage III non-small cell lung cancer (NSCLC). https://clinicaltrials.gov/ct2/show/NCT03840902. Accessed April 22, 2020. 

 

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