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)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:October 19, 2018
End Date:June 18, 2026
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for
participants with advanced NSCLC with high PD-L1-tumor expression.


Inclusion Criteria:

- Histologically confirmed diagnosis of advanced NSCLC

- 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.

- Have measurable disease based on RECIST 1.1

- Have a life expectancy of at least 3 months

- Availability of either tumor archival material (less than 6 months old) or fresh
biopsies collected within 28 days (excluding bone biopsies) before the first dose is
mandatory to determine PD-L1 expression level prior to enrollment

- PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1
immunohistochemistry 22C3 pharmDx assay

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing
(activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1
rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved

- 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

- Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or
any components in their formulations

- Previous malignant disease (other than the target malignancy to be investigated in
this study) within the last 3 years

- Other protocol defined exclusion criteria could apply
We found this trial at
10
sites
Orange, California 92868
Principal Investigator: Viola Zhu, Dr.
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Orange, CA
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from
Decatur, IL
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Escondido, California 92025
Principal Investigator: Joseph Pascuzzo, Dr.
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from
Escondido, CA
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from
Huntsville, AL
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Lincoln, Nebraska 68510
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from
Lincoln, NE
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Midland Park, New Jersey 07432
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from
Midland Park, NJ
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from
Norwich, CT
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mi
from
Nyack, NY
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Pellenberg,
Principal Investigator: Johan Vansteenkiste, Prof.
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from
Pellenberg,
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mi
from
Wenatchee, WA
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