Trial · NCT03840915
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
NCT03840915, Phase 1, Phase 2, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2023-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC). Trials, record NCT03840915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03840915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT03840915
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Cisplatin, Carboplatin, Pemetrexed, Nab-paclitaxel, Gemcitabine, Docetaxel, M7824, Carboplatin, Carboplatin, Bintrafusp alfa, Paclitaxel
- First posted
- 2019-02-15
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2018-004040-28
- Results first posted
- 2023-08-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) | Day 1 Week 1 up to Week 3 | DLT was defined as Adverse Events(AEs) with any of following toxicities: Grade 4 nonhematologic toxicity or hematologic toxicity lasting more than equal to(\>=) 7 days despite medical intervention; Grade 3 nausea, vomiting, and diarrhea lasting \>= 3 days despite supportive care; Any Grade 3 or Grade 4 nonhematologic lab value leading to hospitalization or persisting for \>= 7 days; Grade 3 or Grade 4: grade 3 is defined as absolute neutrophil count (ANC) less than (\<) 1,000/Cubic Millimeter(mm3) with a temperature of \> 38.3 degree Celsius (°C); grade 4 is defined as ANC \< 1,000/mm3 with a temperature of \> 38.3°C, with life-threatening consequences; Thrombocytopenia \< 25,000/mm3 associated with bleeding not resulting in hemodynamic instability or a life-threatening bleeding resulting in urgent intervention; Bleeding events \>= Grade 3 occurring within 5 days of bintrafusp alfa treatment; Prolonged delay(\> 3 weeks) in initiating Cycle 2 due to treatment-related toxicity; Grade 5 toxicity. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Time from first treatment assessed up to approximately 26 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. 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. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. |
| Secondary | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC) | Time from first treatment assessed up to approximately 26 months | Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. |
| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | Time from first administration of study drug until the first documentation of PD or death, assessed up to approximately 26 months | PFS was defined as the time from first administration of study intervention until date of 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 SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS. |
| Secondary | Overall Survival (OS) | Time from first treatment assessed up to approximately 26 months | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) | Time from first documentation of a confirmed objective response to PD or death due to any cause (assessed up to approximately 26 months) | DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response \[CR\] or Partial Response \[PR\]) according to RECIST 1.1 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. Results were calculated based on Kaplan-Meier estimates. |
| Secondary | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | Ceoi was the observed concentration at the end of the infusion period. This was taken directly from the observed Bintrafusp Alfa concentration-time data. |
| Secondary | Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | Ctrough was the serum concentration observed immediately before next dosing. |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | The area under the concentration-time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from terminal first order (elimination) rate constant determination. AUC0-inf= AUC0-tlast +Clast pred/ terminal first order (elimination) rate constant. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicities (DLTs) | Day 1 Week 1 up to Week 3 | Dose-Limiting Toxicity Analysis (DLT) Set included all participants who received at least 90 percent (%) of the bintrafusp alfa infusion and all other planned study administrations during the DLT observation period of 3 weeks and who did not discontinue the study for other reasons than DLT during the first cycle, or who experienced at least one DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Time from first treatment assessed up to approximately 26 months | The safety analysis set (SAF) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator (IRC) | Time from first treatment assessed up to approximately 26 months | The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies). | Percentage of Participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | Time from first administration of study drug until the first documentation of PD or death, assessed up to approximately 26 months | The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies) | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from first treatment assessed up to approximately 26 months | The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies) | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Time from first documentation of a confirmed objective response to PD or death due to any cause (assessed up to approximately 26 months) | The full analysis set (FAS) included all participants who were administered any dose of any study intervention (bintrafusp alfa or one of the chemotherapies) | months | MEDIAN |
| SECONDARY | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected. | ||
| SECONDARY | Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected. | ||
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected. | ||
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp Alfa | Predose, Day 22, Day 43, Day 64 and Day 85 | In the context of Study NCT03631706, NCT04066491, and NCT03840902 been terminated prematurely, the sponsor decided to restrict the analyses of Pharmacokinetics (PK) Parameter and no PK data was collected. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 1 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 1 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Cohort D: Bintrafusp Alfa + Docetaxel | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | TEAEs | 40 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | TEAEs | 9 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | TEAEs | 9 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort D: Bintrafusp Alfa + Docetaxel | TEAEs | 12 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | Serious TEAEs | 31 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | Serious TEAEs | 5 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 40 | |
| Overall Study | STARTED | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 9 | |
| Overall Study | STARTED | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 9 | |
| Overall Study | STARTED | Cohort D: Bintrafusp Alfa + Docetaxel | 12 | |
| Overall Study | Safety Analysis Set | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 40 | |
| Overall Study | Safety Analysis Set | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 9 | |
| Overall Study | Safety Analysis Set | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 9 | |
| Overall Study | Safety Analysis Set | Cohort D: Bintrafusp Alfa + Docetaxel | 12 | |
| Overall Study | Full Analysis Set | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 40 | |
| Overall Study | Full Analysis Set | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 9 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,596
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 | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 20 | 40 | 28 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 6 | 9 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 9 | 9 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort D: Bintrafusp Alfa + Docetaxel | 9 | 12 | 9 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 1 | 40 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 0 | 9 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 1 | 9 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort D: Bintrafusp Alfa + Docetaxel | 0 | 12 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 1 | 40 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 0 | 9 | 0 |
1 to 10 of 1,596Source ClinicalTrials.gov
See all 1,596 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 23 | 40 |
| Total, all-cause mortality | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 4 | 9 |
| Total, all-cause mortality | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 4 | 9 |
| Total, all-cause mortality | Cohort D: Bintrafusp Alfa + Docetaxel | 6 | 12 |
| Total, other adverse events | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 40 | 40 |
| Total, other adverse events | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 9 | 9 |
| Total, other adverse events | Cohort C: Bintrafusp Alfa + Cisplatin/Carboplatin + Gemcitabine | 9 | 9 |
| Total, other adverse events | Cohort D: Bintrafusp Alfa + Docetaxel | 12 | 12 |
| Total, serious adverse events | Cohort A: Bintrafusp Alfa + Cisplatin/Carboplatin + Pemetrexed | 31 | 40 |
| Total, serious adverse events | Cohort B: Bintrafusp Alfa + Carboplatin + Paclitaxel or Nab-paclitaxel | 5 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36066618 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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