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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Lung, Non Small Cell, Phase I
Phase I/II
Adults
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Carboplatin, Cisplatin, Docetaxel (Taxotere), Gemcitabine, M7824, Nab-Paclitaxel, Paclitaxel, Pemetrexed
Horn, Leora
International
Vanderbilt University
01-08-2020
Treatment
VICCTHO1920
NCT03840915

Eligibility

18 Years
BOTH
NO
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 [
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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