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 |
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.
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
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