CompletedPhase 1 / Phase 2NCT03840915

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

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

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations19
SponsorEMD Serono Research & Development Institute, Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

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

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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.

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