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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)

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ClinicalTrials.gov Identifier: NCT03631706
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description
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Brief Summary:
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: M7824 Drug: Pembrolizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: M7824 Drug: M7824
Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.
Active Comparator: Pembrolizumab Drug: Pembrolizumab
Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) assessed by Independent Review Committee (IRC) [ Time Frame: Time from randomization to planned final assessment at approximately up to 60 months ]
  2. Overall survival (OS) [ Time Frame: Randomization to approximately up to 60 months ]

Secondary Outcome Measures :
  1. 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 at approximately up to 60 months ]
  2. Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment expected at up to 60 months ]
  3. 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 approximately up to 60 months ]
  4. 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 approximately 60 months) ]
  5. 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 approximately 60 months) ]
  6. 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 approximately 60 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central testing
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631706


Locations
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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03631706    
Other Study ID Numbers: MS200647_0037
2018-001517-32 ( EudraCT Number )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
M7824
Pembrolizumab
PD-L1-tumor Expression
INTR@PID Lung 037
Bintrafusp alfa
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents