18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by InvestigatorPrimary· 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.
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
3.7
1.9 – 5.6
cCRT Plus Placebo Followed by Durvalumab
3.7
1.8 – 3.9
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse EventsSecondary· 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
Participants with TEAEs
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
70
cCRT Plus Placebo Followed by Durvalumab
74
Participants with immunotherapy related TEAE
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
48
cCRT Plus Placebo Followed by Durvalumab
48
Participants with cisplatin/etoposide chemotherapy regimen related TEAE
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
7
cCRT Plus Placebo Followed by Durvalumab
11
Participants with carboplatin/paclitaxel chemotherapy regimen related TEAE
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
46
cCRT Plus Placebo Followed by Durvalumab
47
Participants with cisplatin/pemetrexed chemotherapy regimen related TEAE
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
15
cCRT Plus Placebo Followed by Durvalumab
11
Participants with radiotherapy related TEAE
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
59
cCRT Plus Placebo Followed by Durvalumab
60
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
4.6
0.1 – 22.3
cCRT Plus Placebo Followed by Durvalumab
4.3
0.3 – 22.7
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by InvestigatorSecondary· 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.
Group
Value
95% CI
cCRT Plus M7824 Followed by M7824
29.3
19.4 – 41.0
cCRT Plus Placebo Followed by Durvalumab
32.1
21.9 – 43.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Time from randomization up to data cut off (assessed up to 27 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
cCRT Plus M7824 Followed by M7824
Serious: 43/74 (58%)
Deaths: 13/75
cCRT Plus Placebo Followed by Durvalumab
Serious: 31/77 (40%)
Deaths: 5/78
Serious adverse events (83 terms)
Reaction
System
cCRT Plus M7824 Followed b…
cCRT Plus Placebo Followed…
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Nausea
Gastrointestinal disorders
—
—
Oesophagitis
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Radiation oesophagitis
Injury, poisoning and procedural complications
—
—
Radiation pneumonitis
Injury, poisoning and procedural complications
—
—
Pneumothorax
Respiratory, thoracic and mediastinal disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Atrioventricular block complete
Cardiac disorders
—
—
Pyrexia
General disorders
—
—
Septic shock
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Haemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Leukopenia
Blood and lymphatic system disorders
—
—
Myelosuppression
Blood and lymphatic system disorders
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Cardiac arrest
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Other adverse events (283 terms — click to expand)
The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04327986 — Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (
· Phase 1, PHASE2
· terminated
NCT04296942 — BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
· Phase 1
· terminated
NCT04633252 — A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01AD
· Phase 1, PHASE2
· recruiting
NCT04417660 — Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
· Phase 2
· active not recruiting
NCT04574583 — Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Com
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 16 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03840902.