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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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

Key facts

Study ID

NCT03840915

Run by

EMD Serono Research & Development Institute, Inc.

People needed

70

Starts

2019-04-02

Expected to finish

2022-07-29

Last updated by the study team

2023-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Compassionate Care Research Group Inc - Edinger Medical Group, Inc. — Fountain Valley, California, United States
• California Cancer Associates for Research & Excellence, Inc. — San Marcos, California, United States
• Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• Baptist Health Lexington Oncology Associates — Lexington, Kentucky, United States
• University of Maryland - DUPLICATE/Pediatric Surgery — Baltimore, Maryland, United States
• RCCA MD LLC - Bethesda — Bethesda, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Universitair Ziekenhuis Brussel - Geriatrie — Brussels, Belgium
• UZ Antwerpen — Edegem, Belgium
• Universitair Ziekenhuis Gent - Medical Oncology — Ghent, Belgium
• CHU Sart Tilman — Liège, Belgium
• AZ Sint-Maarten — Mechelen, Belgium
• Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha — Bordeaux, France
• Centre Georges François Leclerc - Unité de Phase I — Dijon, France
• Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage — Marseille, France
• ICO - Site René Gauducheau — Nantes, France
• Centre Antoine Lacassagne — Nice, France
• CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale — Poitiers, France

Full record on ClinicalTrials.gov

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