Clinical Trials /

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

NCT03840915

Description:

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

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

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
  • Official Title: A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: MS200647_0024
  • SECONDARY ID: 2018-004040-28
  • NCT ID: NCT03840915

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
CisplatinCohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
CarboplatinCohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
PemetrexedCohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
Nab-paclitaxelCohort B: Carboplatin + Nab-paclitaxel + M7824
GemcitabineCohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
DocetaxelCohort D: Docetaxel + M7824
M7824Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
CarboplatinCohort B: Carboplatin + Nab-paclitaxel + M7824
CarboplatinCohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
M7824Cohort B: Carboplatin + Nab-paclitaxel + M7824

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824Experimental
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • M7824
Cohort B: Carboplatin + Nab-paclitaxel + M7824Experimental
  • Nab-paclitaxel
  • Carboplatin
  • M7824
Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824Experimental
  • Cisplatin
  • Gemcitabine
  • Carboplatin
  • M7824
Cohort D: Docetaxel + M7824Experimental
  • Docetaxel
  • M7824

Eligibility Criteria

        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 chemotherapy are enrolled
                  in Cohort D

          -  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, anaplastic lymphoma kinase (ALK) translocation, ROS1
             rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved

          -  Mixed small cell with non-small cell lung 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 and, have no evidence of new
             or enlarging brain metastases

          -  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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Dose Limiting Toxicities (DLTs)
Time Frame:Day 1 to Day 21 (Cycle 1)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Confirmed Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi)
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough)
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M7824
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Maximum Observed Serum Concentration (Cmax) of M7824
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Time to Reach Maximum Serum Concentration (Tmax) of M7824
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Apparent Terminal Half-life (t1/2) of M7824
Time Frame:Up to 3 years
Safety Issue:
Description:
Measure:Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay
Time Frame:Up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:EMD Serono Research & Development Institute, Inc.

Trial Keywords

  • Non-small Cell Lung Cancer
  • Bintrafusp alfa (proposed INN)
  • M7824
  • Stage IV
  • INTR@PID LUNG 024

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