Description:
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.
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: 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
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0037
- SECONDARY ID:
2018-001517-32
- NCT ID:
NCT03631706
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
M7824 | | M7824 |
Pembrolizumab | | Pembrolizumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
M7824 | Experimental | | |
Pembrolizumab | Active Comparator | | |
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 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
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 (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 |
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 at approximately up to 60 months |
Safety Issue: | |
Description: | |
Measure: | 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 |
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 approximately up to 60 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 approximately 60 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 approximately 60 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 approximately 60 months) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- M7824
- Pembrolizumab
- PD-L1-tumor Expression
- INTR@PID Lung 037
- Bintrafusp alfa
Last Updated
October 20, 2020