Clinical Trials /

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

NCT03631706

Description:

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
  • Official Title: A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: MS200647_0037
  • SECONDARY ID: 2018-001517-32
  • NCT ID: NCT03631706

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
M7824M7824
PembrolizumabPembrolizumab

Purpose

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

Trial Arms

NameTypeDescriptionInterventions
M7824Experimental
  • M7824
PembrolizumabActive Comparator
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of advanced NSCLC

          -  Have not received prior systemic therapy treatment for their advanced/Stage four
             NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or
             radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was
             completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation
             of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy
             to Grade less than or equal to 1. For radiation toxicity or prior major surgeries,
             participants should have recovered from side effects and/or complications.

          -  Have measurable disease based on RECIST 1.1

          -  Have a life expectancy of at least 3 months

          -  Availability of either tumor archival material (less than 6 months old) or fresh
             biopsies collected within 28 days (excluding bone biopsies) before the first dose is
             mandatory to determine PD-L1 expression level prior to enrollment

          -  PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1
             immunohistochemistry 22C3 pharmDx assay

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing
             (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1
             rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved

          -  Has received major surgery within 4 weeks prior to the first dose of study
             intervention; received thoracic radiation therapy of greater than 30 units of gray
             (Gy) within 6 months prior to the first dose of study

          -  Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or
             any components in their formulations

          -  Previous malignant disease (other than the target malignancy to be investigated in
             this study) within the last 3 years

          -  Other protocol defined exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee
Time Frame:Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time Frame:Randomization up to the last safety follow-up visit, expected at approximately 47 months
Safety Issue:
Description:
Measure:Overall Survival (OS) Time
Time Frame:Randomization up to 49 months
Safety Issue:
Description:
Measure:Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator
Time Frame:Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months
Safety Issue:
Description:
Measure:Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator
Time Frame:Time from randomization to planned final assessment, expected at 37 months
Safety Issue:
Description:
Measure:Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee
Time Frame:Time from CR or PR to planned assessment, expected at 37 months
Safety Issue:
Description:
Measure:Concentration of M7284 at the end of Infusion (Ceoi)
Time Frame:Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)
Safety Issue:
Description:
Measure:Concentration of M7284 at the end of the Dosing Interval (C trough)
Time Frame:Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months)
Safety Issue:
Description:
Measure:Immunogenicity as measured by Anti-drug Antibodies Concentration
Time Frame:Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:EMD Serono Research & Development Institute, Inc.

Trial Keywords

  • M7824
  • Pembrolizumab
  • PD-L1-tumor Expression

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