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 : February 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: M7824 Drug: Pembrolizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 304 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 1, 2018 |
Actual Primary Completion Date : | June 7, 2021 |
Estimated Study Completion Date : | June 29, 2022 |

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. |
- 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 ]
- Overall survival (OS) [ Time Frame: Randomization to approximately up to 60 months ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Medical Responsible | Merck KGaA, Darmstadt, Germany |
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: | February 3, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union |
Access Criteria: | Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal. |
URL: | http://bit.ly/IPD21 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
M7824 Pembrolizumab PD-L1-tumor Expression INTR@PID Lung 037 Bintrafusp alfa |
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 |