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.
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.
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There are 8 Locations for this study
Fountain Valley California, 92708, United States
San Marcos California, 92069, United States
Port Saint Lucie Florida, 34952, United States
Lexington Kentucky, 40503, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20817, United States
Detroit Michigan, 48202, United States
Nashville Tennessee, 37232, United States
Bruxelles , , Belgium
Edegem , , Belgium
Gent , , Belgium
Liège , , Belgium
Mechelen , , Belgium
Bordeaux cedex , , France
Dijon cedex , , France
Marseille cedex 5 , , France
Nantes Cedex 01 , , France
Nice cedex 02 , , France
Poitiers Cedex , , France
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