Trial · NCT04394624
Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)
NCT04394624, Phase 2, Terminated, Sanofi; results first posted 2024-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04). Trials, record NCT04394624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04394624
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)
- NCT number
- NCT04394624
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- SAR408701, ramucirumab, pembrolizumab
- First posted
- 2020-05-19
- Last updated
- 2025-06-06
- Other registries' IDs
- eudract:2019-003914-15
- Results first posted
- 2024-03-28
- Limitations and caveats
- The study was prematurely terminated due to the discontinuation of the overall development of tusamitamab ravtansine (SAR408701) by the sponsor. The decision was not related to any safety concern.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Doublet Cohort - Part 1: Number of Participants With Study Drug-Related Dose-Limiting Toxicity (DLT) | From Cycle 1 Day 1 up to Cycle 2 Day 14, approximately 28 days | The following AEs occurred during the first 2 cycles of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: • Grade 4 neutropenia for 7 or more consecutive days. • Grade 3 to 4 neutropenia complicated by fever. • Grade \>=3 thrombocytopenia. • Elevated urine protein \>=3 gram(g)/24 hour. • Grade 4 non-hematologic AE. • Grade \>=3 keratopathy. • Grade 4 or refractory hypertension. In addition, any other AE that the Investigators and sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT. |
| Primary | Doublet Cohort - Part 2: Objective Response Rate (ORR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | The ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR is defined as disappearance of all target lesions. The PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Triplet Cohort: Number of Participants With Study Drug-Related Dose-Limiting Toxicity | From Cycle 1 Day 1 up to Cycle 1 Day 21 | The following AEs occurred during the first cycle of treatment, unless due to disease progression or to a cause obviously unrelated to study drug, were considered DLTs: • Grade 4 neutropenia for 7 or more consecutive days. • Grade 3 to 4 neutropenia complicated by fever. • Grade \>=3 thrombocytopenia. • Elevated urine protein \>=3 g/24 hour. • Grade 4 non-hematologic AE. • Grade \>=3 keratopathy. • Grade 4 or refractory hypertension. In addition, any other AE that the Investigators and sponsor deemed dose limiting, regardless of its grade, was also considered as DLT. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or congenital anomaly/birth defect. TEAE is defined as AEs that develop, worsen, or become serious during the treatment period. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the hematology laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Metabolism | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the clinically significant abnormalities in metabolism. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Electrolytes | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the clinically significant abnormalities in electrolytes. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Renal Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the renal function laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Liver Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | Blood samples were collected to determine the liver function laboratory clinically significant abnormalities. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities: Electrocardiogram (ECG) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | A single 12-lead ECG was recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only those participants with data collected are reported. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Metabolism | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Electrolytes | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Renal Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Liver Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Electrocardiogram (ECG) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Urinalysis | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Doublet Cohort: Duration of Response (DOR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only responders (participants with CR or PR with confirmation of response by investigator) were analyzed in this outcome measure. | months | MEDIAN |
| SECONDARY | Doublet Cohort: Progression-Free Survival (PFS) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group60
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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Any TEAE | 31 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Any treatment-emergent SAE | 7 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Anemia | 19 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | White blood cell decreased | 8 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Neutrophil count decreased | 8 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Lymphocyte count decreased | 11 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Eosinophilia | 12 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Platelet count decreased | 21 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | International normalized ratio increased | 2 | Participants | |
| Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | Activated partial thromboplastin time prolonged | 11 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 31 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 0 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | |
| Overall Study | NOT COMPLETED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 31 | |
| Overall Study | NOT COMPLETED | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 |
Source ClinicalTrials.gov
Adverse events138
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 | Covid-19 | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 7 | 31 | 7 |
| other | Covid-19 | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | ||
| other | Cystitis | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 3 | 31 | 5 |
| other | Cystitis | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | ||
| other | Rash Pustular | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 2 | 31 | 2 |
| other | Rash Pustular | Infections and infestations | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | ||
| other | Pyogenic Granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 2 | 31 | 2 |
| other | Pyogenic Granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | ||
| other | Neutropenia | Blood and lymphatic system disorders | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 2 | 31 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 13 | 31 |
| Total, all-cause mortality | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | 0 |
| Total, other adverse events | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 31 | 31 |
| Total, other adverse events | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | 0 |
| Total, serious adverse events | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab | 7 | 31 |
| Total, serious adverse events | Tusamitamab Ravtansine 100 mg/m^2 + Ramucirumab + Pembrolizumab | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT04394624
GET https://conductscience.org/api/trials/v1/NCT04394624/results?page=2