Trial · NCT05245071
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
NCT05245071, Phase 2, Terminated, Sanofi; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA. Trials, record NCT05245071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05245071
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
- NCT number
- NCT05245071
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Interventions
- Tusamitamab ravtansine
- First posted
- 2022-02-17
- Last updated
- 2025-08-29
- Other registries' IDs
- eudract:2021-004423-32
- Results first posted
- 2025-03-25
- Limitations and caveats
- The study was terminated as per Sponsor decision and not related to any safety concern.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | The ORR was 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 was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent disability/incapacity or congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. TEAE was defined as AEs that developed, worsened, or became serious during the treatment-emergent period. |
| Secondary | Progression-Free Survival (PFS) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | The PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first as per RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Disease Control Rate (DCR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | The DCR was defined as the percentage of participants who achieved confirmed CR, PR or stable disease (SD) as BOR as per RECIST v1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. The PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on the study. |
| Secondary | Duration of Response (DOR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | The DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
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 | Objective Response Rate (ORR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only responders (those participants with confirmed CR or PR) were included in the analysis. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Tusamitamab Ravtansine 100 mg/m^2 | 9.1 | 95% Confidence Interval 1.12 to 29.16 | percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Tusamitamab Ravtansine 100 mg/m^2 | Any TEAEs | 21 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Tusamitamab Ravtansine 100 mg/m^2 | Any TESAEs | 7 | Participants | |
| Progression-Free Survival (PFS) | Tusamitamab Ravtansine 100 mg/m^2 | 1.87 | 95% Confidence Interval 1.676 to 3.614 | months | |
| Disease Control Rate (DCR) | Tusamitamab Ravtansine 100 mg/m^2 | 36.4 | 95% Confidence Interval 17.20 to 59.34 | percentage of participants | |
| Duration of Response (DOR) | Tusamitamab Ravtansine 100 mg/m^2 | NA | 95% Confidence Interval NA to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2) | 22 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2) | 0 | |
| Overall Study | NOT COMPLETED | Tusamitamab Ravtansine 100 Milligrams Per Meter Square (mg/m^2) | 22 |
Source ClinicalTrials.gov
Adverse events29
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 | Decreased Appetite | Metabolism and nutrition disorders | Tusamitamab Ravtansine 100 mg/m^2 | 9 | 22 | 10 |
| other | Keratitis | Eye disorders | Tusamitamab Ravtansine 100 mg/m^2 | 3 | 22 | 6 |
| other | Keratopathy | Eye disorders | Tusamitamab Ravtansine 100 mg/m^2 | 3 | 22 | 3 |
| other | Hypertension | Vascular disorders | Tusamitamab Ravtansine 100 mg/m^2 | 3 | 22 | 3 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 3 | 22 | 3 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 2 | 22 | 2 |
| other | Constipation | Gastrointestinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 3 | 22 | 3 |
| other | Nausea | Gastrointestinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 6 | 22 | 7 |
| other | Stomatitis | Gastrointestinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 2 | 22 | 2 |
| other | Vomiting | Gastrointestinal disorders | Tusamitamab Ravtansine 100 mg/m^2 | 2 | 22 | 3 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tusamitamab Ravtansine 100 mg/m^2 | 13 | 22 |
| Total, other adverse events | Tusamitamab Ravtansine 100 mg/m^2 | 18 | 22 |
| Total, serious adverse events | Tusamitamab Ravtansine 100 mg/m^2 | 7 | 22 |
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/NCT05245071
GET https://conductscience.org/api/trials/v1/NCT05245071/events?page=2