Non-squamous Non-small Cell Lung CancerPhase 2CARMEN-LC06NCT05245071
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
A Phase 2 study testing Tusamitamab ravtansine in people with Non-squamous Non-small Cell Lung Cancer, run by Sanofi at 35 sites in 7 countries.
Trial summary
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Tusamitamab ravtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 1 Jun 2022to 20 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
Who cannot join
- Patients with untreated brain metastases or history of leptomeningeal disease.
- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- History of known uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
- Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
- Nonresolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
- Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
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- Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
- Concurrent treatment with any other anticancer therapy
- Poor bone marrow, liver or kidney functions.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
Spain9 sites
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], 08028
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], 08036
Investigational Site Number : 7240001
L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad de, 28041
Investigational Site Number : 7240009
Madrid / Madrid, Madrid, Comunidad de, 28040
Investigational Site Number : 7240008
Majadahonda, Madrid, 28222
Investigational Site Number : 7240003
Málaga, 29010
Investigational Site Number : 7240005
Seville, 41013
Investigational Site Number : 7240007
Valencia, 46026
France8 sites
Investigational Site Number : 2500003
Bordeaux, 33076
Investigational Site Number : 2500001
Créteil, 94010
Investigational Site Number : 2500007
Marseille, 13015
Investigational Site Number : 2500005
Montpellier, 34295
Investigational Site Number : 2500002
Rennes, 35033
Investigational Site Number : 2500006
Saint-Herblain, 44800
Investigational Site Number : 2500008
Saint-Mandé, 94160
Investigational Site Number : 2500009
Villejuif, 94800
Turkey (Türkiye)5 sites
Investigational Site Number : 7920002
Adana, 01120
Investigational Site Number : 7920005
Ankara, 06800
Investigational Site Number : 7920003
Istanbul, 34300
Investigational Site Number : 7920004
Istanbul, 34722
Investigational Site Number : 7920001
Malatya
Italy4 sites
Investigational Site Number : 3800004
Aviano (PN), Friuli Venezia Giulia, 33081
Investigational Site Number : 3800002
Milan, 20133
Investigational Site Number : 3800003
Ravenna, Emilia-Romagna, 48121
Investigational Site Number : 3800001
Rozzano, Lombardy, 20089
Japan4 sites
Investigational Site Number : 3920005
Hirakata-shi, Osaka, 573-1191
Investigational Site Number : 3920002
Nagoya, Aichi-ken, 460-0001
Investigational Site Number : 3920001
Sapporo, Hokkaido, 003-0804
Investigational Site Number : 3920003
Sunto Gun, Shizuoka, 411-8777
Belgium3 sites
Investigational Site Number : 0560003
Edegem, 2650
Investigational Site Number : 0560001
Leuven, 3000
Investigational Site Number : 0560002
Liège, 4000
United States2 sites
Roswell Park Cancer Institute Site Number : 8400004
Buffalo, New York, 14263
Renovatio Clinical Site Number : 8400003
El Paso, Texas, 79915
About this study
Official title: Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).
Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
Read the detailed description
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Tusamitamab ravtansine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tusamitamab ravtansineDrug
Also called SAR408701
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Tusamitamab ravtansine | Experimental | Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle). Receives: Drug: Tusamitamab ravtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Secondary outcomes (4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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.
Measured: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks
Progression-Free Survival (PFS)
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.
Measured: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Disease Control Rate (DCR)
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.
Measured: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Duration of Response (DOR)
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.
Measured: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jun 2022
- Primary completion6 Mar 2024
- Study completion20 Nov 2024
Why it stopped: Sponsor decision, the decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245071
- Sponsor's protocol ID
- ACT17241
- Other IDs
- U1111-1264-2828, 2021-004423-32
- Acronym
- CARMEN-LC06
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2022
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
- ClinicalTrials.gov ID
- NCT05245071
- Acronym / sponsor ID
- CARMEN-LC06 / ACT17241
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, the decision is not related to any safety concern.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).
Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
Detailed description
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tusamitamab ravtansine | Experimental | Drug: Tusamitamab ravtansineTusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
Key exclusion criteria (10 listed)
- Patients with untreated brain metastases or history of leptomeningeal disease.
- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- History of known uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
- Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
- Nonresolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tusamitamab ravtansineAlso: SAR408701Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion | Drug | Tusamitamab ravtansine |
Primary outcome
Objective Response Rate (ORR)
Time frame: 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.
4 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks
Progression-Free Survival (PFS)
Time frame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Disease Control Rate (DCR)
Time frame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Duration of Response (DOR)
Time frame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tusamitamab ravtansine in people with Non-squamous Non-small Cell Lung Cancer, run by Sanofi at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Spain, France, Turkey (Türkiye), Italy, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.