Trial · NCT04524689
Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
NCT04524689, Phase 2, Terminated, Sanofi; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC. Trials, record NCT04524689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04524689
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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 Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
- NCT number
- NCT04524689
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
- Interventions
- SAR408701 (Tusamitamab ravtansine), Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed
- First posted
- 2020-08-24
- Last updated
- 2025-10-29
- Results first posted
- 2025-03-17
- Limitations and caveats
The study was terminated due to the discontinuation of the overall development of tusamitamab ravtansine by the Sponsor and the enrollment of new participants in this study had been stopped on 21 December 2023.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks) | DLTs were defined as: a) Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever (temperature ≥38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection, grade ≥3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention; b) Non-hematological abnormalities: grade 4 non-hematologic adverse event (AE), except AE symptoms related to the underlying disease as per the Investigator's judgment, grade ≥3 keratopathy. In addition, any other AE that the recruiting Investigators and sponsor deemed to be dose-limiting, regardless of its grade, was also considered as DLT. |
| Primary | Doublet Cohort: Objective Response Rate (ORR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks | ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (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. |
| Primary | Quadruplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks | ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have 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 | All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet) | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE 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 or was a congenital anomaly/birth defect. A TEAE was defined as an AE that developed, worsened or became serious during the treatment-emergent period. |
| Secondary | Doublet and Quadruplet Cohorts: Progression-free Survival (PFS) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet) | 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. 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 (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression. |
| Secondary | All Cohorts: Disease Control Rate (DCR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | DCR was defined as percentage of participants with a confirmed CR, confirmed PR or stable disease (SD) as BOR per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have 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. 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 diameters while on study. 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 (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression. |
| Secondary | All Cohorts: Duration of Response (DOR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | 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. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have 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 at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression. |
| Secondary | Triplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks | ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have 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 | All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | Blood samples were collected for the measurement of tusamitamab ravtansine concentrations. |
| Secondary | All Cohorts: Ctrough of Pembrolizumab | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | Blood samples were collected for the measurement of pembrolizumab concentrations. |
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 | All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks) | DLT-evaluable population included participants who received 1 cycle with at least 80% of the intended dose for each study treatment of the combination during the safety run-in at both doses of tusamitamab ravtansine in Part A (doublet cohort), Part B (triplet cohort) or Part C (quadruplet cohort). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Doublet Cohort: Objective Response Rate (ORR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| PRIMARY | Quadruplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Doublet and Quadruplet Cohorts: Progression-free Survival (PFS) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | months | MEDIAN |
| SECONDARY | All Cohorts: Disease Control Rate (DCR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Duration of Response (DOR) | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet) | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Only participants with confirmed CR or PR as BOR were included in the analysis. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | months | MEDIAN |
| SECONDARY | Triplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks | All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part B (triplet cohort) at both tusamitamab ravtansine doses. | percentage of participants | NUMBER |
| SECONDARY | All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | All Cohorts: Ctrough of Pembrolizumab | Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks) | PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses. | mcg/mL | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 0 | Participants | ||
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 0 | Participants | ||
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 0 | Participants | ||
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 0 | Participants | ||
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 0 | Participants | ||
| All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 1 | Participants | ||
| Doublet Cohort: Objective Response Rate (ORR) | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 47.8 | 95% Confidence Interval 26.82 to 69.41 | percentage of participants | |
| Doublet Cohort: Objective Response Rate (ORR) | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 0 | 95% Confidence Interval 0.00 to 84.19 | percentage of participants | |
| Quadruplet Cohort: Objective Response Rate | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 59.1 | 95% Confidence Interval 36.35 to 79.29 | percentage of participants | |
| Quadruplet Cohort: Objective Response Rate | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 66.7 | 95% Confidence Interval 9.43 to 99.16 | percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 23 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 2 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 6 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 22 | |
| Overall Study | STARTED | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 3 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 7 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 1 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 4 | |
| Overall Study | COMPLETED | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events768
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 | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 1 | 23 | 1 |
| other | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 0 | 2 | 0 |
| other | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 | 6 | 1 |
| other | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 0 | 1 | 0 |
| other | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 1 | 22 | 1 |
| other | Nasopharyngitis | Infections and infestations | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 0 | 3 | 0 |
| other | Purulence | Infections and infestations | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 0 | 23 | 0 |
| other | Purulence | Infections and infestations | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 0 | 2 | 0 |
| other | Purulence | Infections and infestations | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 | 6 | 1 |
| other | Purulence | Infections and infestations | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 0 | 1 | 0 |
1 to 10 of 768Source ClinicalTrials.gov
See all 768 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 5 | 23 |
| Total, all-cause mortality | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 0 | 2 |
| Total, all-cause mortality | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 2 | 6 |
| Total, all-cause mortality | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 | 1 |
| Total, all-cause mortality | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 11 | 22 |
| Total, all-cause mortality | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed | 0 | 3 |
| Total, other adverse events | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab | 22 | 23 |
| Total, other adverse events | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab | 2 | 2 |
| Total, other adverse events | Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 6 | 6 |
| Total, other adverse events | Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin | 1 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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.
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