Status:
COMPLETED
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Eligibility Criteria
Inclusion
- 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:
- Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC
- Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention.
- 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
- The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic lymphoma kinase (ALK) positive, if targeted therapy is locally approved
- Mixed small cell with NSCLC 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 after the end of the RT and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (MRI)
- 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)
- Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material.
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03840915
Start Date
April 2 2019
End Date
July 29 2022
Last Update
August 21 2023
Active Locations (19)
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1
Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
Fountain Valley, California, United States, 92708
2
California Cancer Associates for Research & Excellence, Inc.
San Marcos, California, United States, 92069
3
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States, 34952
4
Baptist Health Lexington Oncology Associates
Lexington, Kentucky, United States, 40503