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Page last updated: 4/15/2020

A phase 1b/2, open-label study evaluating bintrafusp alfa with chemotherapy for the treatment of patients with stage IV non-small cell lung cancer (NSCLC).

STAGE IV

PHASE 1/2

COMBINATION
THERAPY


ClinicalTrials.gov: NCT03840915

Locatione: Europe and North America

Countries: Belgium, France, and the United States

Status:

Now Enrolling

 

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


Key inclusion criteria*


  • Participants must not have mixed small cell with NSCLC histology or have tumors containing an EGFR-sensitizing (activating) mutation, ROS1 rearrangement, or BRAF V600E mutation or that are ALK positive if targeted therapy is locally approved
  • Participants in cohorts A-C must not have received prior therapy targeting T-cell co-stimulation or checkpoint pathways

Key exclusion criteria*


  • Participants must have histologically confirmed stage IV NSCLC and an ECOG PS of 0 or 1
  • Participants in cohorts A-C must not have received prior systemic therapy for their stage IV NSCLC, and participants in cohort D must have experienced disease progression on previous treatment with PD-L1 inhibitors in combination with platinum-based chemotherapy
 
Study Design | Europe and North America

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 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.

Treatment is given for 4 cycles, each lasting 21 days. 

Maintenance is given for up to 31 cycles. 

ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene, serine/threonine kinase; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; IV, intravenous; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; Q3W, every 3 weeks; ROS1, ROS proto-oncogene 1.

References

ClinicalTrials.gov. M7824 in combination with chemotherapy in stage IV non-small cell lung cancer (NSCLC). https://clinicaltrials.gov/ct2/show/NCT03840915. Accessed April 15, 2020.

 

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