AzTrials
AzTrials

Non-small Cell Lung Cancer MetastaticPhase 3CARMEN-LC03NCT04154956

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

A Phase 3 study testing SAR408701 and Docetaxel in people with Non-small Cell Lung Cancer Metastatic, run by Sanofi at 169 sites in 26 countries.

Terminated

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

Official record
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Trial summary

Primary Objectives: Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) Study success was defined either on PFS or OS The primary objective was to determine whether… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
SAR408701 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
389 participants
Where
169 sitesin 26 countries
Study dates
6 Feb 2020to 16 Apr 2026
Phase
Phase 3
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

  • At least 18 years of age or above (or country's legal age of maturity if above 18 years) and signed the informed consent.
  • Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
  • Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
  • At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • A female participant who agreed to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
  • A male participant who agreed to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.

Who cannot join

  • Participants with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.
  • Significant concomitant illnesses, including all severe medical conditions that would impair the 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.
  • Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
  • History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
  • Previous history of and/or unresolved corneal disorders. The use of contact lenses was not permitted.
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  • Concurrent treatment with any other anticancer therapy.
  • Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
  • Contraindicated the use of corticosteroid premedication.
  • Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
  • Poor bone marrow, liver or kidney functions
  • Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicated participation in the study.
  • The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial locations and contacts

169 sites in 26 countries.

169 sites in 26 countries

China29 sites

  • Investigational Site Number : 1560026

    Beijing, 100142

  • Investigational Site Number : 1560009

    Changchun, 130012

  • Investigational Site Number : 1560010

    Changchun, 130021

  • Investigational Site Number : 1560015

    Changsha, 410006

  • Investigational Site Number : 1560039

    Changsha, 410011

  • Investigational Site Number : 1560032

    Chengdu, 610041

  • Investigational Site Number : 1560038

    Chengdu, 610041

  • Investigational Site Number : 1560044

    Chongqing, 400038

  • Investigational Site Number : 1560043

    Chongqing, 400042

  • Investigational Site Number : 1560024

    Fuzhou, 350008

  • Investigational Site Number : 1560001

    Guangzhou, 510080

  • Investigational Site Number : 1560036

    Guangzhou, 510095

  • Investigational Site Number : 1560037

    Guangzhou, 510163

  • Investigational Site Number : 1560017

    Guangzhou, 510515

  • Investigational Site Number : 1560025

    Hangzhou, 310003

  • Investigational Site Number : 1560033

    Hangzhou, 310009

  • Investigational Site Number : 1560021

    Hangzhou, 310014

  • Investigational Site Number : 1560011

    Hangzhou, 310022

  • Investigational Site Number : 1560005

    Harbin, 150081

  • Investigational Site Number : 1560050

    Huizhou, 516001

  • Investigational Site Number : 1560047

    Jinan, 250013

  • Investigational Site Number : 1560023

    Nanjing, 210006

  • Investigational Site Number : 1560019

    Nanjing, 210009

  • Investigational Site Number : 1560012

    Nanning, 530021

  • Investigational Site Number : 1560045

    Tianjin, 300060

  • Investigational Site Number : 1560006

    Wuhan, 430079

  • Investigational Site Number : 1560016

    Zhanjiang, 524001

  • Investigational Site Number : 1560041

    Zhengzhou, 450003

  • Investigational Site Number : 1560040

    Zhengzhou, 450008

Other trials in China

Japan17 sites

  • Investigational Site Number : 3920011

    Bunkyo-ku, Tokyo, 113-8603

  • Investigational Site Number : 3920012

    Fukuoka, Fukuoka, 810-8563

  • Investigational Site Number : 3920017

    Himeji-shi, Hyōgo, 670-8520

  • Investigational Site Number : 3920001

    Hirakata-shi, Osaka, 573-1191

  • Investigational Site Number : 3920006

    Kanazawa, Ishikawa-ken, 920-8641

  • Investigational Site Number : 3920008

    Kurume-shi, Fukuoka, 830-0011

  • Investigational Site Number : 3920018

    Mitaka-shi, Tokyo, 181-8611

  • Investigational Site Number : 3920002

    Nagoya, Aichi-ken, 460-0001

  • Investigational Site Number : 3920015

    Nagoya, Aichi-ken, 464-8681

  • Investigational Site Number : 3920009

    Natori-shi, Miyagi, 981-1293

  • Investigational Site Number : 3920003

    Osaka, Osaka, 541-8567

  • Investigational Site Number : 3920013

    Osaka Sayama-shi, Osaka, 589-8511

  • Investigational Site Number : 3920016

    Sapporo, Hokkaido, 003-0804

  • Investigational Site Number : 3920004

    Sunto-gun, Shizuoka, 411-8777

  • Investigational Site Number : 3920010

    Ube-shi, Yamaguchi, 755-0241

  • Investigational Site Number : 3920007

    Wakayama, Wakayama, 641-8510

  • Investigational Site Number : 3920005

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France13 sites

  • Investigational Site Number : 2500010

    Bordeaux, 33076

  • Investigational Site Number : 2500008

    Caen, 14076

  • Investigational Site Number : 2500006

    Créteil, 94010

  • Investigational Site Number : 2500007

    Grenoble, 38043

  • Investigational Site Number : 2500001

    Marseille, 13015

  • Investigational Site Number : 2500013

    Montpellier, 34295

  • Investigational Site Number : 2500011

    Paris, 75231

  • Investigational Site Number : 2500014

    Paris, 75970

  • Investigational Site Number : 2500009

    Pierre-Bénite, 69495

  • Investigational Site Number : 2500003

    Rennes, 35033

  • Investigational Site Number : 2500012

    Saint-Herblain, 44800

  • Investigational Site Number : 2500002

    Saint-Mandé, 94160

  • Investigational Site Number : 2500004

    Villejuif, 94800

Other trials in France

Turkey (Türkiye)11 sites

  • Investigational Site Number : 7920008

    Adana, 01060

  • Investigational Site Number : 7920012

    Adana, 01140

  • Investigational Site Number : 7920002

    Adana, 01250

  • Investigational Site Number : 7920011

    Ankara, 06800

  • Investigational Site Number : 7920005

    Istanbul, 34214

  • Investigational Site Number : 7920001

    Istanbul, 34303

  • Investigational Site Number : 7920006

    Istanbul, 34722

  • Investigational Site Number : 7920007

    Izmir

  • Investigational Site Number : 7920010

    Izmir

  • Investigational Site Number : 7920014

    Kocaeli, 41100

  • Investigational Site Number : 7920009

    Malatya

Other trials in Turkey (Türkiye)

Spain9 sites

  • Investigational Site Number : 7240007

    Barcelona, Barcelona [Barcelona], 08028

  • Investigational Site Number : 7240005

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7240001

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908

  • Investigational Site Number : 7240002

    Madrid, 28041

  • Investigational Site Number : 7240009

    Madrid / Madrid, Madrid, Comunidad de, 28040

  • Investigational Site Number : 7240004

    Málaga, 29010

  • Investigational Site Number : 7240006

    Pamplona, Navarre, 31008

  • Investigational Site Number : 7240011

    Seville, 41013

  • Investigational Site Number : 7240008

    Valencia, 46026

Other trials in Spain

United States8 sites

  • Roswell Park Cancer Institute Site Number : 8400011

    Buffalo, New York, 14263-0001

  • Renovatio Clinical- Site Number : 8400032

    El Paso, Texas, 79915

  • Florida Cancer Specialists South Division- Site Number : 8400020

    Fort Myers, Florida, 33901

  • Ca & Hem Center Of W Michigan- Site Number : 8400016

    Grand Rapids, Michigan, 49546

  • Medical College of Wisconsin- Site Number : 8400006

    Milwaukee, Wisconsin, 53226

  • Florida Cancer Specialists North Division- Site Number : 8400019

    St. Petersburg, Florida, 33705

  • Renovatio Clinical - Site Number : 8400013

    The Woodlands, Texas, 77380

  • Lankenau Hospital Cancer Center- Site Number : 8400017

    Wynnewood, Pennsylvania, 19096-3411

Other trials in United States

Argentina7 sites

  • Investigational Site Number : 0320001

    Buenos Aires, 1426ANZ

  • Investigational Site Number : 0320004

    Buenos Aires, C1125ABD

  • Investigational Site Number : 0320009

    CABA, Buenos Aires, C1019ABS

  • Investigational Site Number : 0320012

    Capital Federal, Buenos Aires, 1012

  • Investigational Site Number : 0320014

    Córdoba, ZCX5000AAI

  • Investigational Site Number : 0320002

    Salta, 4400

  • Investigational Site Number : 0320003

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Romania7 sites

  • Investigational Site Number : 6420008

    Alba Iulia, 510077

  • Investigational Site Number : 6420009

    Brasov, 500152

  • Investigational Site Number : 6420003

    Bucaresti, 022328

  • Investigational Site Number : 6420010

    Cluj-Napoca, 400124

  • Investigational Site Number : 6420011

    Cluj-Napoca, 407280

  • Investigational Site Number : 6420012

    Otopeni, 75100

  • Investigational Site Number : 6420005

    Timișoara, 300166

Other trials in Romania

South Korea7 sites

  • Investigational Site Number : 4100008

    Busan, Busan, 48108

  • Investigational Site Number : 4100005

    Cheongju-si, North Chungcheong, 28644

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100007

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 07061

  • Investigational Site Number : 4100001

    Seoul, 06591

Other trials in South Korea

Belgium6 sites

  • Investigational Site Number : 0560006

    Anderlecht, 1070

  • Investigational Site Number : 0560004

    Edegem, B-2650

  • Investigational Site Number : 0560005

    Ghent, 9000

  • Investigational Site Number : 0560001

    Leuven, 3000

  • Investigational Site Number : 0560003

    Liège, 4000

  • Investigational Site Number : 0560002

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Brazil6 sites

  • Clínica de Oncologia Reichow Site Number : 0760023

    Blumenau, Santa Catarina, 89010-340

  • ~Instituto De Oncologia Parana- Site Number : 0760008

    Curitiba, Paraná, 80530-010

  • Centro Regional Integrado De Oncologia - CRIO- Site Number : 0760002

    Fortaleza, Ceará, 60336-232

  • Centro Avancado de Oncologia CECAN - Liga Contra o Cancer- Site Number : 0760026

    Natal, Rio Grande do Norte, 59062-000

  • Hospital de Base Sao Jose do Rio Preto Site Number : 0760001

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Sirio Libanes- Site Number : 0760018

    São Paulo, São Paulo, 01308050

Other trials in Brazil

Bulgaria6 sites

  • Investigational Site Number : 1000008

    Burgas, 8000

  • Investigational Site Number : 1000010

    Pleven, 5800

  • Investigational Site Number : 1000007

    Plovdiv, 4002

  • Investigational Site Number : 1000004

    Sofia, 1330

  • Investigational Site Number : 1000003

    Sofia, 1618

  • Investigational Site Number : 1000001

    Sofia, 1797

Other trials in Bulgaria

Chile5 sites

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7500713

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500921

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana de Santiago, 7650568

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383

  • Investigational Site Number : 1520001

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Greece5 sites

  • Investigational Site Number : 3000005

    Athens, 11526

  • Investigational Site Number : 3000001

    Athens, 11527

  • Investigational Site Number : 3000003

    Heraklion, 71500

  • Investigational Site Number : 3000004

    Ioannina, 455 00

  • Investigational Site Number : 3000006

    Thessaloniki, 54645

Other trials in Greece

Italy5 sites

  • Investigational Site Number : 3800006

    Catania

  • Investigational Site Number : 3800001

    Milan, 20133

  • Investigational Site Number : 3800003

    Orbassano, Torino, 10043

  • Investigational Site Number : 3800004

    Ravenna, Emilia-Romagna, 48121

  • Investigational Site Number : 3800005

    Rozzano, Milano, 20089

Other trials in Italy

Portugal5 sites

  • Investigational Site Number : 6200002

    Almada, 2801-951

  • Investigational Site Number : 6200001

    Lisbon, 1769

  • Investigational Site Number : 6200004

    Lisbon, 1998-018

  • Investigational Site Number : 6200005

    Porto, 4099-001

  • Investigational Site Number : 6200006

    Porto, 4100-180

Other trials in Portugal

Australia3 sites

  • Investigational Site Number : 0360002

    Blacktown, New South Wales, 2148

  • Investigational Site Number : 0360003

    Waratah, New South Wales, 2298

  • Investigational Site Number : 0360001

    Woolloongabba, Queensland, 4102

Other trials in Australia

Hungary3 sites

  • Investigational Site Number : 3480003

    Budapest, 1121

  • Investigational Site Number : 3480007

    Budapest, 1125

  • Investigational Site Number : 3480005

    Kaposvár, 7400

Other trials in Hungary

Israel3 sites

  • Investigational Site Number : 3760001

    Haifa, 3109601

  • Investigational Site Number : 3760002

    Kfar Saba, 44281

  • Investigational Site Number : 3760003

    Petah Tikva, 49100

Other trials in Israel

Netherlands3 sites

  • Investigational Site Number : 5280003

    's-Hertogenbosch, 5223 GZ

  • Investigational Site Number : 5280004

    Breda, 4818 CK

  • Investigational Site Number : 5280005

    Utrecht, 3543 AZ

Other trials in Netherlands

Canada2 sites

  • Investigational Site Number : 1240003

    Greenfield Park, Quebec, J4V 2H1

  • Investigational Site Number : 1240010

    Montreal, Quebec, H1T 1P7

Other trials in Canada

Germany2 sites

  • Investigational Site Number : 2760002

    Essen, 45147

  • Investigational Site Number : 2760001

    Heidelberg, 69126

Other trials in Germany

Poland2 sites

  • Investigational Site Number : 6160004

    Olsztyn, Warmian-Masurian Voivodeship, 10-357

  • Investigational Site Number : 6160001

    Warsaw, 02-781

Other trials in Poland

Russia2 sites

  • Investigational Site Number : 6430001

    Moscow, 115478

  • Investigational Site Number : 6430003

    Saint Petersburg, 197758

Other trials in Russia

Singapore2 sites

  • Investigational Site Number : 7020001

    Singapore, 308433

  • Investigational Site Number : 7020002

    Singapore, 329563

Other trials in Singapore

Mexico1 site

  • Investigational Site Number : 4840003

    Cuauhtémoc, Mexico City, 06700

Other trials in Mexico

About this study

Official title: Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors

Primary Objectives:

  • Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS])
  • Study success was defined either on PFS or OS
  • The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
  • The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.
Read more

Secondary Objectives:

  • Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
  • Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
  • Evaluated the safety of tusamitamab ravtansine compared to docetaxel
  • Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Read the detailed description

The median expected duration of study per participant was estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the EOT and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up).

Being tested
SAR408701, Docetaxel

What participants receive

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

  • SAR408701Drug

    Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion

  • DocetaxelDrug

    Also called TAXOTERE

    Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion

Study groups in NCT04154956
Study groupRoleWhat they receive
SAR408701 (tusamitamab ravtansine)ExperimentalParticipants received tusamitamab ravtansine 100 milligrams per square meter (mg/m^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).
Receives: Drug: SAR408701
DocetaxelActive comparatorParticipants received docetaxel 75 mg/m^2 by IV infusion, once every 3 weeks (Q3W) until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 weeks).
Receives: Drug: Docetaxel

What is being measured

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

  1. Progression-free Survival (PFS)

    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).

    Measured: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

  2. Overall Survival (OS)

    Overall survival was defined as the time from date of randomization to date of death due to any cause.

    Measured: From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    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.

    Measured: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

  2. 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)

    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).

    Measured: 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

  3. 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)

    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.

    Measured: 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

  4. TTD in Role Function Measured by EORTC QLQ C30

    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.

    Measured: 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

  5. 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 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.

    Measured: 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

  6. Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters

    Blood samples were collected to determine the abnormalities in hematology parameters.

    Measured: 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

  7. Number of Participants With PCSA in Clinical Chemistry

    Blood samples were collected to determine the clinical chemistry laboratory abnormalities.

    Measured: 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

  8. Duration of Response (DOR)

    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.

    Measured: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

Timeline

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

  1. First posted7 Nov 2019
  2. Study start6 Feb 2020
  3. Primary completion22 Sep 2023
  4. Study completion16 Apr 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154956
Sponsor's protocol ID
EFC15858
Other IDs
U1111-1233-0781, 2024-515101-26-00, 2019-001273-81, 2019
Acronym
CARMEN-LC03
Status last verified
Apr 2026
First submitted
5 Nov 2019
Last updated
18 May 2026
Data monitoring committee
Yes
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 3 study testing SAR408701 and Docetaxel in people with Non-small Cell Lung Cancer Metastatic, run by Sanofi at 169 sites in 26 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 13 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in China, Japan, France, Turkey (Türkiye), Spain and 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Nov 2024). 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?

Progression-free Survival (PFS) (time frame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks). The study lists 2 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 NCT04154956.

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 18 May 2026.

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