For Healthcare Professionals

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)

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About the study

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically confirmed diagnosis of advanced NSCLC
  2. Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
  3. Have measurable disease based on RECIST 1.1
  4. Have a life expectancy of at least 3 months
  5. Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  6. PD-L1 high status as determined by central testing
  7. Other protocol defined inclusion criteria could apply

EXCLUSION CRITERIA

  1. Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
  2. Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
  3. Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
  4. Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
  5. Other protocol defined exclusion criteria could apply
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 888-275-7376Email iconEmail Study Center

Study’s details


Contition

Non-small Cell Lung Cancer

Age (in years)

18 - 200

Phase

Phase 3

Participants needed

304

Est. Completion Date

Jul 2023

Treatment type

Interventional


Sponsor

EMD Serono

ClinicalTrials.gov identifier

NCT03631706

Study number

MS200647-0037

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