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M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

NCT03840915•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC
•2. 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.

Locations (19)

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

Key Dates

Start Date

April 2, 2019

Primary Completion Date

July 29, 2022

Completion Date

July 29, 2022

Last Updated

August 21, 2023

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

Docetaxel

DRUG

M7824

DRUG

Carboplatin

DRUG

Carboplatin

DRUG

Bintrafusp alfa

DRUG

Paclitaxel

DRUG

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

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RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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