Trial · NCT04154956
SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
NCT04154956, Phase 3, Terminated, Sanofi; results first posted 2024-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients. Trials, record NCT04154956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04154956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
- NCT number
- NCT04154956
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 389 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Interventions
- SAR408701, Docetaxel
- First posted
- 2019-11-07
- Last updated
- 2026-05-18
- Other registries' IDs
- eudract:2019-001273-81
- Results first posted
- 2024-11-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | PFS was defined as the time from the date of randomization to the date of the first documentation of objective PD as assessed by radiological review committee (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) definitions or death due to any cause before the study cut-off date, whichever occurred first. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; 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 millimeters (mm). |
| Primary | Overall Survival (OS) | From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks | Overall survival was defined as the time from date of randomization to date of death due to any cause. |
| Secondary | Objective Response Rate (ORR) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | ORR was defined as the percentage of participants who had a complete response (CR) or partial response (PR), as best overall response derived from overall response (OR) determined by the IRC per RECIST 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13) | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | The TTD was defined as the time from baseline (Cycle 1, Day 1) until the first ≥10-point change from baseline up to the end of treatment assessment before the initiation of further anticancer therapy and the analysis cut-off date. For the TTD in disease-related symptoms (cough, dyspnea, pain) from EORTC QLQ LC-13, a deterioration was defined as an increase from baseline score of at least 10 points in any 1 of these 3 symptoms. The EORTC QLQ-LC13 (LC13) is the lung cancer module of the EORTC QLQ-C30 that assesses lung-cancer-associated symptoms (cough, dyspnea, pain, hemoptysis) and side-effects from conventional chemotherapy and radiotherapy (sore mouth, hair loss, dysphagia and neuropathy). The EORTC QLQ-LC13 contains 13 items. Items on the LC13 were scored using the LC13 scoring algorithms which standardize the raw scores to a 0-100 range. Lower scores indicate lower symptomology/symptom burden (lower scores better). |
| Secondary | TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30) | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | TTD was defined as time from baseline(Cycle 1,Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date.For TTD in physical function from EORTC QLQ-C30, deterioration=decrease of at least 10 points from baseline score.EORTC QLQ-C30(C30) is 30-item, cancer specific that includes global health status/health-related quality of life(GHS/QoL), functional scales(physical,role,emotional,cognitive,social), symptom scales(fatigue,nausea\&vomiting,pain), 5 symptom items(dyspnea,insomnia,appetite loss,constipation,diarrhea,perceived financial difficulties). Most questions from QLQ-C30 were rated on 4-point scale(1/Not at All to 4/Very Much), except Items 29-30,which comprise GHS scale and were rated on 7-point scale(1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0-100. High score represented favorable outcome with best quality of life. |
| Secondary | TTD in Role Function Measured by EORTC QLQ C30 | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | TTD was defined as time from baseline (Cycle 1, Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date. For TTD in role function from EORTC QLQ-C30, deterioration = decrease of at least 10 points from baseline score. EORTC QLQ-C30 (C30) is a 30-item, cancer specific that includes GHS/QoL, functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, nausea \& vomiting, pain), 5 symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, perceived financial difficulties item). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period. |
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | Blood samples were collected to determine the abnormalities in hematology parameters. |
| Secondary | Number of Participants With PCSA in Clinical Chemistry | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | Blood samples were collected to determine the clinical chemistry laboratory abnormalities. |
| Secondary | Duration of Response (DOR) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | DOR was defined as the time from the date of first initial occurrence of a CR or PR to the date of first documentation of objective PD according to RECIST 1.1 before the initiation of any posttreatment anticancer therapy or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; 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. |
Source ClinicalTrials.gov
Outcomes10
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) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | The intent-to-treat (ITT) population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | months | MEDIAN |
| PRIMARY | Overall Survival (OS) | From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported. | percentage of participants | NUMBER |
| SECONDARY | Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13) | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | months | MEDIAN |
| SECONDARY | TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30) | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | months | MEDIAN |
| SECONDARY | TTD in Role Function Measured by EORTC QLQ C30 | Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | |||
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | |||
| SECONDARY | Number of Participants With PCSA in Clinical Chemistry | From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks | |||
| SECONDARY | Duration of Response (DOR) | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
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) | Tusamitamab Ravtansine | 5.39 | 95% Confidence Interval 3.713 to 6.998 | months | |
| Progression-free Survival (PFS) | Docetaxel | 5.85 | 95% Confidence Interval 5.520 to 7.359 | months | |
| Overall Survival (OS) | Tusamitamab Ravtansine | 12.81 | 95% Confidence Interval 11.795 to 14.160 | months | |
| Overall Survival (OS) | Docetaxel | 11.53 | 95% Confidence Interval 8.936 to 15.244 | months | |
| Objective Response Rate (ORR) | Tusamitamab Ravtansine | 21.7 | 95% Confidence Interval 16.04 to 28.26 | percentage of participants | |
| Objective Response Rate (ORR) | Docetaxel | 24.1 | 95% Confidence Interval 18.13 to 30.84 | percentage of participants | |
Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13) | Tusamitamab Ravtansine | 2.83 | 95% Confidence Interval 2.103 to 4.304 | months | |
Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13) | Docetaxel | 1.87 | 95% Confidence Interval 1.544 to 2.793 | months | |
| TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30) | Tusamitamab Ravtansine | 7.46 | 95% Confidence Interval 5.552 to 15.211 | months | |
| TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30) | Docetaxel | 4.17 | 95% Confidence Interval 3.023 to 4.567 | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tusamitamab Ravtansine | 194 | |
| Overall Study | STARTED | Docetaxel | 195 | |
| Overall Study | Randomized and Treated | Tusamitamab Ravtansine | 194 | |
| Overall Study | Randomized and Treated | Docetaxel | 177 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine | 48 | |
| Overall Study | COMPLETED | Docetaxel | 52 | |
| Overall Study | NOT COMPLETED | Tusamitamab Ravtansine | 146 | |
| Overall Study | NOT COMPLETED | Docetaxel | 143 |
Source ClinicalTrials.gov
Adverse events284
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 | Neutropenia | Blood and lymphatic system disorders | Tusamitamab Ravtansine | 3 | 194 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel | 10 | 177 | 12 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Tusamitamab Ravtansine | 39 | 194 | 40 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Docetaxel | 41 | 177 | 51 |
| other | Insomnia | Psychiatric disorders | Tusamitamab Ravtansine | 8 | 194 | 9 |
| other | Insomnia | Psychiatric disorders | Docetaxel | 14 | 177 | 14 |
| other | Dysgeusia | Nervous system disorders | Tusamitamab Ravtansine | 5 | 194 | 6 |
| other | Dysgeusia | Nervous system disorders | Docetaxel | 15 | 177 | 17 |
| other | Headache | Nervous system disorders | Tusamitamab Ravtansine | 8 | 194 | 8 |
| other | Headache | Nervous system disorders | Docetaxel | 9 | 177 | 10 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tusamitamab Ravtansine | 109 | 194 |
| Total, all-cause mortality | Docetaxel | 110 | 195 |
| Total, other adverse events | Tusamitamab Ravtansine | 159 | 194 |
| Total, other adverse events | Docetaxel | 151 | 177 |
| Total, serious adverse events | Tusamitamab Ravtansine | 55 | 194 |
| Total, serious adverse events | Docetaxel | 68 | 177 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tusamitamab Ravtansine vs Docetaxel: deaths from any cause | Trial comparisons |
| Tusamitamab Ravtansine vs Docetaxel: 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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