Trial · NCT03631706
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)
NCT03631706, Phase 3, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2022-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03631706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03631706
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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)
- NCT number
- NCT03631706
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 304 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- M7824, Pembrolizumab
- First posted
- 2018-08-15
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2018-001517-32
- Results first posted
- 2022-06-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days | Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Overall Survival (OS) | Time from randomization of study drug assessed approximately up to 843 days | Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Time from first treatment assessed up to approximately 843 days | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. |
| Secondary | Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days | Percentage of participants with unconfirmed best overall response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. |
| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | From first documented objective response to PD or death due to any cause, assessed approximately up to 746 days | DOR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days | Full analysis set included all participants who were randomized to study intervention. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Time from randomization of study drug assessed approximately up to 843 days | Full analysis set included all participants who were randomized to study intervention. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Time from first treatment assessed up to approximately 843 days | Safety analysis set included all participants who were administered at least one dose of M7824 or Pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days | Full analysis set included all participants who were randomized to study intervention. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | From first documented objective response to PD or death due to any cause, assessed approximately up to 746 days | Full analysis set included all participants who were randomized to study intervention. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | M7824 | 7.0 | Full Range 0.0 to 19.4 | months | |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Pembrolizumab | 11.1 | Full Range 0.0 to 18.0 | months | |
| Overall Survival (OS) | M7824 | 21.1 | Full Range 0.2 to 22.1 | months | |
| Overall Survival (OS) | Pembrolizumab | 22.1 | Full Range 0.1 to 26.4 | months | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | M7824 | Participants with any TEAE | 150 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Pembrolizumab | Participants with any TEAE | 145 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | M7824 | Participants with any serious TEAE | 90 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Pembrolizumab | Participants with any serious TEAE | 61 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | M7824 | Participants with any Treatment Related TEAEs | 124 | Participants | |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | Pembrolizumab | Participants with any Treatment Related TEAEs | 105 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | M7824 | 152 | |
| Overall Study | STARTED | Pembrolizumab | 152 | |
| Overall Study | Treated | M7824 | 151 | |
| Overall Study | Treated | Pembrolizumab | 152 | |
| Overall Study | COMPLETED | M7824 | 151 | |
| Overall Study | COMPLETED | Pembrolizumab | 152 | |
| Overall Study | NOT COMPLETED | M7824 | 1 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events402
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | M7824 | 46 | 151 | |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab | 18 | 152 | |
| other | Hyperthyroidism | Endocrine disorders | M7824 | 6 | 151 | |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab | 10 | 152 | |
| other | Hypothyroidism | Endocrine disorders | M7824 | 17 | 151 | |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab | 23 | 152 | |
| other | Abdominal pain upper | Gastrointestinal disorders | M7824 | 3 | 151 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pembrolizumab | 8 | 152 | |
| other | Constipation | Gastrointestinal disorders | M7824 | 16 | 151 | |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab | 22 | 152 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | M7824 | 49 | 151 |
| Total, all-cause mortality | Pembrolizumab | 43 | 152 |
| Total, other adverse events | M7824 | 140 | 151 |
| Total, other adverse events | Pembrolizumab | 135 | 152 |
| Total, serious adverse events | M7824 | 90 | 151 |
| Total, serious adverse events | Pembrolizumab | 61 | 152 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| M7824 vs Pembrolizumab: deaths from any cause | Trial comparisons |
| M7824 vs Pembrolizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03631706
GET https://conductscience.org/api/trials/v1/NCT03631706/events?page=2