Lung Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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:

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 Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT03840915

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 8 Locations for this study

See Locations Near You

Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
Fountain Valley California, 92708, United States
California Cancer Associates for Research & Excellence, Inc.
San Marcos California, 92069, United States
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast
Port Saint Lucie Florida, 34952, United States
Baptist Health Lexington Oncology Associates
Lexington Kentucky, 40503, United States
University of Maryland - DUPLICATE/Pediatric Surgery
Baltimore Maryland, 21201, United States
RCCA MD LLC - Bethesda
Bethesda Maryland, 20817, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Universitair Ziekenhuis Brussel - Geriatrie
Bruxelles , , Belgium
UZ Antwerpen
Edegem , , Belgium
Universitair Ziekenhuis Gent - Medical Oncology
Gent , , Belgium
CHU Sart Tilman
Liège , , Belgium
AZ Sint-Maarten
Mechelen , , Belgium
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
Bordeaux cedex , , France
Centre Georges François Leclerc - Unité de Phase I
Dijon cedex , , France
Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage
Marseille cedex 5 , , France
ICO - Site René Gauducheau
Nantes Cedex 01 , , France
Centre Antoine Lacassagne
Nice cedex 02 , , France
CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale
Poitiers Cedex , , France

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT03840915

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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