Clinical Trials /

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

NCT03840902

Description:

The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
  • Official Title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: MS200647_0005
  • SECONDARY ID: 2018-003265-34
  • NCT ID: NCT03840902

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
M7824Arm 1: cCRT plus M7824 followed by M7824
PlaceboArm 2: cCRT plus placebo followed by durvalumab
DurvalumabArm 2: cCRT plus placebo followed by durvalumab
EtoposideArm 1: cCRT plus M7824 followed by M7824
PemetrexedArm 1: cCRT plus M7824 followed by M7824
CarboplatinArm 1: cCRT plus M7824 followed by M7824
PaclitaxelArm 1: cCRT plus M7824 followed by M7824
CisplatinArm 1: cCRT plus M7824 followed by M7824

Purpose

The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Trial Arms

NameTypeDescriptionInterventions
Arm 1: cCRT plus M7824 followed by M7824ExperimentalParticipants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
  • M7824
  • Etoposide
  • Pemetrexed
  • Carboplatin
  • Paclitaxel
  • Cisplatin
Arm 2: cCRT plus placebo followed by durvalumabActive ComparatorParticipants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.
  • Placebo
  • Durvalumab
  • Etoposide
  • Pemetrexed
  • Carboplatin
  • Paclitaxel
  • Cisplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have histologically documented NSCLC who present with Stage III
             locally advanced, unresectable disease (International Association for the Study of
             Lung Cancer Staging Manual in Thoracic Oncology

          -  Participants with tumor harboring an Epidermal growth factor receptor (EGFR)
             sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation,
             ROS-1 rearrangement are eligible.

          -  Participants must have adequate pulmonary function defined as a forced expiratory
             volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of
             predicted normal volume measured within 3 weeks prior to randomization.

          -  Adequate hematological, hepatic and renal function as defined in the protocol

          -  Contraceptive use by males or females will be consistent with local regulations on
             contraception methods for those participating in clinical studies

        Exclusion Criteria:

          -  Participants with Mixed small cell with non-small cell lung cancer histology

          -  Recent major surgery within 4 weeks prior to entry into the study

          -  Significant acute or chronic infections including human immunodeficiency virus (HIV)
             or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or
             hepatitis C virus (HCV) infection and active tuberculosis

          -  Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
             requiring hospitalization

          -  Active autoimmune disease that has required systemic treatment in past 1 year (i.e.,
             with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)

          -  Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug
             targeting T-cell coregulatory proteins
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Assessed by Independent Review Committee (IRC)
Time Frame:Time from first dose up to 59 Months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Changes from Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Programmed death-ligand 1 (PD-L1) Expression in Tumors Assessed with Immunohistochemistry (IHC) and Association with Efficacy
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Objective Response According to RECIST 1.1 Assessed by IRC
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Duration of Response According to RECIST 1.1
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays
Time Frame:Baseline up to 8.8 years
Safety Issue:
Description:
Measure:Concentration Immediately Before Next Dosing (Ctrough)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Concentration Immediately at End of Infusion (Ceoi)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Changes from Baseline in High-resolution Computed Tomography (HRCT)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Changes from Baseline in Forced Expiratory Volume in one Second (FEV1)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Changes from Baseline in Forced Vital Capacity (FVC)
Time Frame:Baseline up to 14 months
Safety Issue:
Description:
Measure:Changes from Baseline in 6-minutes Walking Test
Time Frame:Baseline up to 14 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:EMD Serono Research & Development Institute, Inc.

Trial Keywords

  • Non-small Cell Lung Cancer
  • Bintrafusp alfa (proposed INN)
  • M7824
  • Durvalumab
  • Stage III
  • INTR@PID LUNG 005

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