Trial · NCT03840902
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
NCT03840902, Phase 2, Terminated, EMD Serono Research & Development Institute, Inc.; results first posted 2024-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC). Trials, record NCT03840902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03840902
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT03840902
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 153 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- M7824, Placebo, Durvalumab, Etoposide, Pemetrexed, Carboplatin, Paclitaxel, Cisplatin, Intensity Modulated Radiation Therapy (IMRT)
- First posted
- 2019-02-15
- Last updated
- 2024-01-16
- Other registries' IDs
- eudract:2018-003265-34
- Results first posted
- 2024-01-16
Source ClinicalTrials.gov
Registered outcomes8
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 Investigator | Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months | PFS was defined as the time from randomization to the date of 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. PFS was analyzed by using the Kaplan-Meier method. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | Time from randomization up to data cut off (assessed up to 27 months) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have 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 | Overall Survival (OS) | Time from randomization to the date of death due to any cause, assessed up to 27 months | Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. |
| Secondary | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Time from randomization up to data cut off (assessed up to 27 months) | ORR was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to RECIST v1.1as adjudicated by the Investigator. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions. |
| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months | DOR was defined 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. |
| Secondary | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824 | Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343 | Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed M7824 concentration-time data. |
| Secondary | Serum Concentration Immediately Before Next Dosing (Ctrough) of M7824 | Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343 | Ctrough was the serum concentration observed immediately before next dosing. |
| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) | Time from randomization up to data cut off (assessed up to 27 months) | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. |
Source ClinicalTrials.gov
Outcomes8
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 Investigator | Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months | Full Analysis Set (FAS) included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | Time from randomization up to data cut off (assessed up to 27 months) | Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Time from randomization to the date of death due to any cause, assessed up to 27 months | FAS included all participants who were randomized to study treatment. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator | Time from randomization up to data cut off (assessed up to 27 months) | FAS included all participants who were randomized to study treatment. | 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 Investigator | Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months | Due to early termination of the study, the data for this outcome measure was not collected. | ||
| SECONDARY | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824 | Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343 | Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed. | ||
| SECONDARY | Serum Concentration Immediately Before Next Dosing (Ctrough) of M7824 | Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343 | Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed. | ||
| SECONDARY | Number of Participants With Positive Antidrug Antibodies (ADA) | Time from randomization up to data cut off (assessed up to 27 months) | Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed. |
Source ClinicalTrials.gov
Results by group18
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 Investigator | cCRT Plus M7824 Followed by M7824 | 3.7 | Full Range 1.9 to 5.6 | months | |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | cCRT Plus Placebo Followed by Durvalumab | 3.7 | Full Range 1.8 to 3.9 | months | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus M7824 Followed by M7824 | Participants with TEAEs | 70 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus Placebo Followed by Durvalumab | Participants with TEAEs | 74 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus M7824 Followed by M7824 | Participants with immunotherapy related TEAE | 48 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus Placebo Followed by Durvalumab | Participants with immunotherapy related TEAE | 48 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus M7824 Followed by M7824 | Participants with cisplatin/etoposide chemotherapy regimen related TEAE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus Placebo Followed by Durvalumab | Participants with cisplatin/etoposide chemotherapy regimen related TEAE | 11 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus M7824 Followed by M7824 | Participants with carboplatin/paclitaxel chemotherapy regimen related TEAE | 46 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events | cCRT Plus Placebo Followed by Durvalumab | Participants with carboplatin/paclitaxel chemotherapy regimen related TEAE | 47 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | cCRT Plus M7824 Followed by M7824 | 75 | |
| Overall Study | STARTED | cCRT Plus Placebo Followed by Durvalumab | 78 | |
| Overall Study | Treated | cCRT Plus M7824 Followed by M7824 | 74 | |
| Overall Study | Treated | cCRT Plus Placebo Followed by Durvalumab | 77 | |
| Overall Study | COMPLETED | cCRT Plus M7824 Followed by M7824 | 74 | |
| Overall Study | COMPLETED | cCRT Plus Placebo Followed by Durvalumab | 77 | |
| Overall Study | NOT COMPLETED | cCRT Plus M7824 Followed by M7824 | 1 | |
| Overall Study | NOT COMPLETED | cCRT Plus Placebo Followed by Durvalumab | 1 |
Source ClinicalTrials.gov
Adverse events732
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 | cCRT Plus M7824 Followed by M7824 | 38 | 74 | 49 |
| other | Anaemia | Blood and lymphatic system disorders | cCRT Plus Placebo Followed by Durvalumab | 32 | 77 | 53 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | cCRT Plus M7824 Followed by M7824 | 1 | 74 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | cCRT Plus Placebo Followed by Durvalumab | 0 | 77 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | cCRT Plus M7824 Followed by M7824 | 1 | 74 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | cCRT Plus Placebo Followed by Durvalumab | 0 | 77 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | cCRT Plus M7824 Followed by M7824 | 9 | 74 | 13 |
| other | Leukopenia | Blood and lymphatic system disorders | cCRT Plus Placebo Followed by Durvalumab | 10 | 77 | 12 |
| other | Lymphopenia | Blood and lymphatic system disorders | cCRT Plus M7824 Followed by M7824 | 4 | 74 | 4 |
| other | Lymphopenia | Blood and lymphatic system disorders | cCRT Plus Placebo Followed by Durvalumab | 3 | 77 | 3 |
1 to 10 of 732Source ClinicalTrials.gov
See all 732 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | cCRT Plus M7824 Followed by M7824 | 13 | 75 |
| Total, all-cause mortality | cCRT Plus Placebo Followed by Durvalumab | 5 | 78 |
| Total, other adverse events | cCRT Plus M7824 Followed by M7824 | 68 | 74 |
| Total, other adverse events | cCRT Plus Placebo Followed by Durvalumab | 72 | 77 |
| Total, serious adverse events | cCRT Plus M7824 Followed by M7824 | 43 | 74 |
| Total, serious adverse events | cCRT Plus Placebo Followed by Durvalumab | 31 | 77 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36177913 | DERIVED |
Source PubMed
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 |
|---|---|
| cCRT Plus M7824 Followed by M7824 vs cCRT Plus Placebo Followed by Durvalumab: deaths from any cause | Trial comparisons |
| cCRT Plus M7824 Followed by M7824 vs cCRT Plus Placebo Followed by Durvalumab: 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.
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