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AzTrials

Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)Phase 2CARMEN-LC05NCT04524689

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

A Phase 2 study testing SAR408701 (Tusamitamab ravtansine), Pembrolizumab and Cisplatin in people with Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC), run by Sanofi at 22 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Primary Objective: Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAR408701 (Tusamitamab ravtansine), Pembrolizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
22 sitesin 8 countries
Study dates
26 Oct 2020to 24 Dec 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-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
  • No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
  • Expression of CEACAM5 as demonstrated prospectively by a centrally assessed Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
  • Measurable disease based on RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Life expectancy of at least 3 months

Who cannot join

  • Medical condition requiring concomitant administration of a medication with a strong CYP3A inhibitor.
  • Uncontrolled brain metastases and history of leptomeningeal disease.
  • Significant concomitant illness, including any severe medical condition that, in the opinion of the investigator or Sponsor, would impair the patient's participation in the study or interpretation of the results.
  • 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 acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
  • History of active autoimmune disease that has required systemic treatment in the past 2 years.
Show all 29Show fewer
  • History of allogeneic tissue/solid organ transplantation.
  • Active infection requiring IV systemic therapy within 2 weeks prior to randomization or active tuberculosis.
  • Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
  • Non-resolution 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.
  • Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted.
  • Symptomatic herpes zoster within 3 months prior to screening.
  • Significant allergies to humanized monoclonal antibodies.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
  • Concurrent treatment with any other anticancer therapy.
  • Have received prior chemotherapy treatment for advanced/metastatic NSCLC.
  • The patient is a candidate for a curative treatment with either surgical resection and/or chemoradiation
  • Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for any investigational treatment).
  • Any prior therapy targeting CEACAM5.
  • Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4.
  • Any prior maytansinoid treatment (DM1 or DM4 ADC).
  • Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication. Daily steroid replacement therapy or any corticosteroid premedication if applicable are allowed.
  • Any radiation therapy to lung >30 Gy within 6 months of first study intervention administration.
  • Has received or will receive a live vaccine within 30 days prior to the first study intervention administration.
  • Any major surgery within the preceding 3 weeks of the first study intervention administration.
  • Prior/concurrent clinical study experience
  • Current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Poor organ function
  • 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

22 sites in 8 countries.

22 sites in 8 countries

Spain6 sites

  • Investigational Site Number : 7240005

    A Coruña, A Coruña [La Coruña], 15006

  • Investigational Site Number : 7240006

    Badalona, Catalunya [Cataluña], 08916

  • Investigational Site Number : 7240002

    Las Palmas, 35016

  • Investigational Site Number : 7240004

    Madrid, 28040

  • Investigational Site Number : 7240001

    Madrid, 28041

  • Investigational Site Number : 7240007

    Oviedo, Principality of Asturias, 33011

Other trials in Spain

Chile4 sites

  • Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002

    Santiago, 7500713

  • ICEGCLINIC Avenida Serafín Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006

    Santiago, 8241470

  • Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005

    Temuco, La Araucanía, 4780000

  • ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

France4 sites

  • Institut Sainte-Catherine 250 Chemin de Baigne-Pieds_Investigational Site Number :2500005

    Avignon, 84918

  • CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003

    Brest, 29200

  • Centre François Magendie Hôpital du Haut Lévèque Av.de Magellan_Investigational Site Number :2500001

    Pessac, 33600

  • Pôle régional de Cancérologie 2 rue de la Milèterie BP 577_Investigational Site Number :2500004

    Poitiers, 86021

Other trials in France

Czechia2 sites

  • Fakultní nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001

    Olomouc, 77900

  • Nemocnice AGEL Ostrava - Vitkovice Plicní oddělení Zalužanského 2214/35_Site Number :2030002

    Ostrava - Vitkovice, 70384

Other trials in Czechia

Hungary2 sites

  • Országos Onkológiai Intézet Ráth György u. 7_Investigational Site Number :3480002

    Budapest, 1122

  • Veszprém Megyei Tüdőgyógyintézet 049/2 Hrsz_Investigational Site Number :3480004

    Farkasgyepü, 8582

Other trials in Hungary

Israel2 sites

  • Investigational Site Number : 3760001

    Ramat Gan, 5266202

  • Investigational Site Number : 3760002

    Tel Aviv, 64239

Other trials in Israel

United States1 site

  • KU Medical Center_Investigational Site Number :8400002

    Westwood, Kansas, 66205

Other trials in United States

Brazil1 site

  • Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004

    Natal, Rio Grande do Norte, 59062-000

Other trials in Brazil

About this study

Official title: Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

Primary Objective:

  • Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population
  • Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
Read more

Secondary Objectives:

  • To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population
  • To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
  • To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
  • To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population
  • To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)
  • To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed
Read the detailed description

The expected duration of study intervention for participants may vary, based on disease progression date; median expected duration of study per participant is estimated at 10 months (up to 1 month for screening, a median of 6 months for treatment, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).

Being tested
SAR408701 (Tusamitamab ravtansine), Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR408701 (Tusamitamab ravtansine)Drug

    Also called Tusamitamab ravtansine

    Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous

  • PembrolizumabDrug

    Also called Keytruda

    Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous

  • CisplatinDrug

    Pharmaceutical form: Lyophilized powder for reconstitution in solution Route of administration: Intravenous

  • CarboplatinDrug

    Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous

  • PemetrexedDrug

    Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous

Study groups in NCT04524689
Study groupRoleWhat they receive
Tusamitamab ravtasine 150 mg/m^2 + PembrolizumabExperimentalPembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab
Tusamitamab ravtasine 170 mg/m^2 + PembrolizumabExperimentalPembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab
Tusamitamab ravtansine 150 mg/m^2 + Pembrolizumab + carboplatin or cisplatinExperimentalPembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Carboplatin will be infused over 15 to 60 minutes immediately after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin
Tusamitamab ravtansine 170 mg/m^2 + Pembrolizumab + carboplatin or cisplatinExperimentalPembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Carboplatin will be infused over 15 to 60 minutes immediately after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after tusamitamab ravtansine infusion on Day 1 and Q3W for the first 4 cycles.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin
Tusamitamab ravtansine 150 mg/m^2 + Pembrolizumab + carboplatin or cisplatin + pemetrexedExperimentalPembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after pemetrexed infusion after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Tusamitamab ravtansine 170 mg/m^2 + Pembrolizumab + carboplatin or cisplatin + pemetrexedExperimentalPembrolizumab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Cisplatin will be infused approximately 30 minutes after pemetrexed infusion after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles.
Receives: Drug: SAR408701 (Tusamitamab ravtansine); Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs)

    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.

    Measured: Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)

  2. Doublet Cohort: Objective Response Rate (ORR)

    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.

    Measured: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks

  3. Quadruplet Cohort: Objective Response Rate

    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.

    Measured: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks

Secondary outcomes (11)

  1. All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    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.

    Measured: 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)

  2. Doublet and Quadruplet Cohorts: Progression-free Survival (PFS)

    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.

    Measured: 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)

  3. All Cohorts: Disease Control Rate (DCR)

    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.

    Measured: 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)

  4. All Cohorts: Duration of Response (DOR)

    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.

    Measured: 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)

  5. Triplet Cohort: Objective Response Rate

    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.

    Measured: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks

  6. All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine

    Blood samples were collected for the measurement of tusamitamab ravtansine concentrations.

    Measured: Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)

  7. All Cohorts: Ctrough of Pembrolizumab

    Blood samples were collected for the measurement of pembrolizumab concentrations.

    Measured: Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)

  8. Quadruplet Cohort: Plasma Concentration of Pemetrexed

    Blood samples were collected for the measurement of pemetrexed concentrations.

    Measured: 30 minutes post-dose on Day 1 of Cycle 1 (cycle duration=3 weeks)

  9. Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion (Ceoi) of Cisplatin

    Blood samples were collected for the measurement of cisplatin concentrations.

    Measured: At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)

  10. Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion of Carboplatin

    Blood samples were collected for the measurement of carboplatin concentrations.

    Measured: At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)

  11. All Cohorts: Number of Participants With Treatment-emergent Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine

    Blood samples were collected to assess the presence of treatment-emergent ATA against tusamitamab ravtansine. ATA incidence was defined as the number of participants found to have treatment-emergent ATA response during the study.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start26 Oct 2020
  3. Primary completion12 Mar 2024
  4. Study completion24 Dec 2024

Why it stopped: Sponsor decision, the decision is not related to any safety concern.

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524689
Sponsor's protocol ID
ACT16146
Other IDs
U1111-1233-9798, 2023-509115-84, 2023
Acronym
CARMEN-LC05
Status last verified
Sep 2025
First submitted
20 Aug 2020
Last updated
29 Oct 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR408701 (Tusamitamab ravtansine), Pembrolizumab and Cisplatin in people with Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC), run by Sanofi at 22 sites in 8 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 7 inclusion and 29 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Spain, Chile, France, Czechia, Hungary and 3 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 17 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?

All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04524689.

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 Oct 2025.

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