M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)



Status:Not yet recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:February 27, 2019
End Date:October 28, 2021
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

The main purpose of the study is to evaluate the safety and tolerability of M7824 in
combination with chemotherapy.


Inclusion Criteria:

- Participants greater than or equals to (>=) 18 years of age inclusive at the time of
signing the informed consent

- Participants who have histologically confirmed diagnosis of Stage IV NSCLC:

1. Participants in Cohort A, B, and C must not have received prior systemic therapy
treatment for their Stage IV NSCLC

2. Participants who had disease progression on previous treatment with Programmed
death-ligand 1 (PD- L1) inhibitors in combination with chemotherapy are enrolled
in Cohort D

- Have measurable disease based on Response evaluation criteria in solid tumors (RECIST)
1.1

- Have a life expectancy of at least 3 months

- Availability of archived tumor material (less than [<] 6 months old) adequate for
biomarker analysis is mandatory at Screening, central laboratory confirmation is
required. Fresh biopsies should be collected if archived tumor material is not
available

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study
entry and date of first dose

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

- Mixed small cell with non-small cell lung cancer histology

- Has received major surgery within 4 weeks prior to the first dose of study
intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6
months prior to the first dose of study intervention

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

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they are clinically stable for at least 2 weeks and, have no evidence of new
or enlarging brain metastases

- Known severe hypersensitivity to study intervention or any components in their
formulations

- For participants in Cohort A, B and C: Has received prior systemic therapy for Stage
IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
We found this trial at
2
sites
Rockland, Massachusetts
Phone: 888-275-7376
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Rockland, MA
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Darmstadt, 64293
Phone: +49 6151 72 5200
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Darmstadt,
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