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

Study summary

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

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin and Carboplatin

Plus 9 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?EMD Serono Research & Development Institute, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: EMD Serono Research & Development Institute, Inc.
Interventions being studied: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Docetaxel; Drug: M7824; Drug: Carboplatin; Drug: Carboplatin; Drug: Bintrafusp alfa; Drug: Paclitaxel

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Compassionate Care Research Group Inc - Edinger Medical Group, Inc.Fountain Valley, California
California Cancer Associates for Research & Excellence, Inc.San Marcos, California
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure CoastPort Saint Lucie, Florida
Baptist Health Lexington Oncology AssociatesLexington, Kentucky
University of Maryland - DUPLICATE/Pediatric SurgeryBaltimore, Maryland
RCCA MD LLC - BethesdaBethesda, Maryland
Henry Ford Health SystemDetroit, Michigan
Vanderbilt University Medical CenterNashville, Tennessee
Universitair Ziekenhuis Brussel - GeriatrieBrussels
UZ AntwerpenEdegem
Universitair Ziekenhuis Gent - Medical OncologyGhent
CHU Sart TilmanLiège

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2023. Always confirm current availability with the study team.

View original record ↗