SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients (CARMEN-LC03)

April 27, 2026 updated by: Sanofi

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426ANZ
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, C1125ABD
        • Investigational Site Number : 0320004
      • Córdoba, Argentina, ZCX5000AAI
        • Investigational Site Number : 0320014
      • Salta, Argentina, 4400
        • Investigational Site Number : 0320002
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1019ABS
        • Investigational Site Number : 0320009
      • Capital Federal, Buenos Aires, Argentina, 1012
        • Investigational Site Number : 0320012
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Investigational Site Number : 0320003
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Investigational Site Number : 0360002
      • Waratah, New South Wales, Australia, 2298
        • Investigational Site Number : 0360003
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Investigational Site Number : 0360001
  • Belgium
      • Anderlecht, Belgium, 1070
        • Investigational Site Number : 0560006
      • Edegem, Belgium, B-2650
        • Investigational Site Number : 0560004
      • Ghent, Belgium, 9000
        • Investigational Site Number : 0560005
      • Leuven, Belgium, 3000
        • Investigational Site Number : 0560001
      • Liège, Belgium, 4000
        • Investigational Site Number : 0560003
      • Woluwe-Saint-Lambert, Belgium, 1200
        • Investigational Site Number : 0560002
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60336-232
        • Centro Regional Integrado De Oncologia - CRIO- Site Number : 0760002
    • Paraná
      • Curitiba, Paraná, Brazil, 80530-010
        • ~Instituto De Oncologia Parana- Site Number : 0760008
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Centro Avancado de Oncologia CECAN - Liga Contra o Cancer- Site Number : 0760026
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clínica de Oncologia Reichow Site Number : 0760023
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Hospital de Base Sao Jose do Rio Preto Site Number : 0760001
      • São Paulo, São Paulo, Brazil, 01308050
        • Hospital Sirio Libanes- Site Number : 0760018
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Investigational Site Number : 1000008
      • Pleven, Bulgaria, 5800
        • Investigational Site Number : 1000010
      • Plovdiv, Bulgaria, 4002
        • Investigational Site Number : 1000007
      • Sofia, Bulgaria, 1330
        • Investigational Site Number : 1000004
      • Sofia, Bulgaria, 1618
        • Investigational Site Number : 1000003
      • Sofia, Bulgaria, 1797
        • Investigational Site Number : 1000001
  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Investigational Site Number : 1240003
      • Montreal, Quebec, Canada, H1T 1P7
        • Investigational Site Number : 1240010
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500713
        • Investigational Site Number : 1520007
      • Santiago, Reg Metropolitana de Santiago, Chile, 7500921
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana de Santiago, Chile, 7650568
        • Investigational Site Number : 1520009
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Investigational Site Number : 1520001
  • China
      • Beijing, China, 100142
        • Investigational Site Number : 1560026
      • Changchun, China, 130012
        • Investigational Site Number : 1560009
      • Changchun, China, 130021
        • Investigational Site Number : 1560010
      • Changsha, China, 410006
        • Investigational Site Number : 1560015
      • Changsha, China, 410011
        • Investigational Site Number : 1560039
      • Chengdu, China, 610041
        • Investigational Site Number : 1560032
      • Chengdu, China, 610041
        • Investigational Site Number : 1560038
      • Chongqing, China, 400038
        • Investigational Site Number : 1560044
      • Chongqing, China, 400042
        • Investigational Site Number : 1560043
      • Fuzhou, China, 350008
        • Investigational Site Number : 1560024
      • Guangzhou, China, 510080
        • Investigational Site Number : 1560001
      • Guangzhou, China, 510095
        • Investigational Site Number : 1560036
      • Guangzhou, China, 510163
        • Investigational Site Number : 1560037
      • Guangzhou, China, 510515
        • Investigational Site Number : 1560017
      • Hangzhou, China, 310003
        • Investigational Site Number : 1560025
      • Hangzhou, China, 310009
        • Investigational Site Number : 1560033
      • Hangzhou, China, 310014
        • Investigational Site Number : 1560021
      • Hangzhou, China, 310022
        • Investigational Site Number : 1560011
      • Harbin, China, 150081
        • Investigational Site Number : 1560005
      • Huizhou, China, 516001
        • Investigational Site Number : 1560050
      • Jinan, China, 250013
        • Investigational Site Number : 1560047
      • Nanjing, China, 210006
        • Investigational Site Number : 1560023
      • Nanjing, China, 210009
        • Investigational Site Number : 1560019
      • Nanning, China, 530021
        • Investigational Site Number : 1560012
      • Tianjin, China, 300060
        • Investigational Site Number : 1560045
      • Wuhan, China, 430079
        • Investigational Site Number : 1560006
      • Zhanjiang, China, 524001
        • Investigational Site Number : 1560016
      • Zhengzhou, China, 450003
        • Investigational Site Number : 1560041
      • Zhengzhou, China, 450008
        • Investigational Site Number : 1560040
  • France
      • Bordeaux, France, 33076
        • Investigational Site Number : 2500010
      • Caen, France, 14076
        • Investigational Site Number : 2500008
      • Créteil, France, 94010
        • Investigational Site Number : 2500006
      • Grenoble, France, 38043
        • Investigational Site Number : 2500007
      • Marseille, France, 13015
        • Investigational Site Number : 2500001
      • Montpellier, France, 34295
        • Investigational Site Number : 2500013
      • Paris, France, 75231
        • Investigational Site Number : 2500011
      • Paris, France, 75970
        • Investigational Site Number : 2500014
      • Pierre-Bénite, France, 69495
        • Investigational Site Number : 2500009
      • Rennes, France, 35033
        • Investigational Site Number : 2500003
      • Saint-Herblain, France, 44800
        • Investigational Site Number : 2500012
      • Saint-Mandé, France, 94160
        • Investigational Site Number : 2500002
      • Villejuif, France, 94800
        • Investigational Site Number : 2500004
  • Germany
      • Essen, Germany, 45147
        • Investigational Site Number : 2760002
      • Heidelberg, Germany, 69126
        • Investigational Site Number : 2760001
  • Greece
      • Athens, Greece, 11527
        • Investigational Site Number : 3000001
      • Athens, Greece, 11526
        • Investigational Site Number : 3000005
      • Heraklion, Greece, 71500
        • Investigational Site Number : 3000003
      • Ioannina, Greece, 455 00
        • Investigational Site Number : 3000004
      • Thessaloniki, Greece, 54645
        • Investigational Site Number : 3000006
  • Hungary
      • Budapest, Hungary, 1121
        • Investigational Site Number : 3480003
      • Budapest, Hungary, 1125
        • Investigational Site Number : 3480007
      • Kaposvár, Hungary, 7400
        • Investigational Site Number : 3480005
  • Israel
      • Haifa, Israel, 3109601
        • Investigational Site Number : 3760001
      • Kfar Saba, Israel, 44281
        • Investigational Site Number : 3760002
      • Petah Tikva, Israel, 49100
        • Investigational Site Number : 3760003
  • Italy
      • Catania, Italy
        • Investigational Site Number : 3800006
      • Milan, Italy, 20133
        • Investigational Site Number : 3800001
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Investigational Site Number : 3800004
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Investigational Site Number : 3800005
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Investigational Site Number : 3800003
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • Investigational Site Number : 3920002
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Investigational Site Number : 3920015
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 810-8563
        • Investigational Site Number : 3920012
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Investigational Site Number : 3920008
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Investigational Site Number : 3920016
    • Hyōgo
      • Himeji-shi, Hyōgo, Japan, 670-8520
        • Investigational Site Number : 3920017
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Investigational Site Number : 3920006
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Investigational Site Number : 3920005
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Investigational Site Number : 3920009
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Investigational Site Number : 3920001
      • Osaka, Osaka, Japan, 541-8567
        • Investigational Site Number : 3920003
      • Osaka Sayama-shi, Osaka, Japan, 589-8511
        • Investigational Site Number : 3920013
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Investigational Site Number : 3920004
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Investigational Site Number : 3920011
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Investigational Site Number : 3920018
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Investigational Site Number : 3920007
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-0241
        • Investigational Site Number : 3920010
  • Mexico
    • Mexico City
      • Cuauhtémoc, Mexico City, Mexico, 06700
        • Investigational Site Number : 4840003
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Investigational Site Number : 5280003
      • Breda, Netherlands, 4818 CK
        • Investigational Site Number : 5280004
      • Utrecht, Netherlands, 3543 AZ
        • Investigational Site Number : 5280005
  • Poland
      • Warsaw, Poland, 02-781
        • Investigational Site Number : 6160001
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
        • Investigational Site Number : 6160004
  • Portugal
      • Almada, Portugal, 2801-951
        • Investigational Site Number : 6200002
      • Lisbon, Portugal, 1769
        • Investigational Site Number : 6200001
      • Lisbon, Portugal, 1998-018
        • Investigational Site Number : 6200004
      • Porto, Portugal, 4099-001
        • Investigational Site Number : 6200005
      • Porto, Portugal, 4100-180
        • Investigational Site Number : 6200006
  • Romania
      • Alba Iulia, Romania, 510077
        • Investigational Site Number : 6420008
      • Brasov, Romania, 500152
        • Investigational Site Number : 6420009
      • Bucaresti, Romania, 022328
        • Investigational Site Number : 6420003
      • Cluj-Napoca, Romania, 400124
        • Investigational Site Number : 6420010
      • Cluj-Napoca, Romania, 407280
        • Investigational Site Number : 6420011
      • Otopeni, Romania, 75100
        • Investigational Site Number : 6420012
      • Timișoara, Romania, 300166
        • Investigational Site Number : 6420005
  • Russia
      • Moscow, Russia, 115478
        • Investigational Site Number : 6430001
      • Saint Petersburg, Russia, 197758
        • Investigational Site Number : 6430003
  • Singapore
      • Singapore, Singapore, 308433
        • Investigational Site Number : 7020001
      • Singapore, Singapore, 329563
        • Investigational Site Number : 7020002
  • South Korea
      • Seoul, South Korea, 06591
        • Investigational Site Number : 4100001
    • Busan
      • Busan, Busan, South Korea, 48108
        • Investigational Site Number : 4100008
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Investigational Site Number : 4100005
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 06351
        • Investigational Site Number : 4100003
      • Seoul, Seoul-teukbyeolsi, South Korea, 03722
        • Investigational Site Number : 4100006
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Investigational Site Number : 4100007
      • Seoul, Seoul-teukbyeolsi, South Korea, 07061
        • Investigational Site Number : 4100004
  • Spain
      • Madrid, Spain, 28041
        • Investigational Site Number : 7240002
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240004
      • Seville, Spain, 41013
        • Investigational Site Number : 7240011
      • Valencia, Spain, 46026
        • Investigational Site Number : 7240008
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08028
        • Investigational Site Number : 7240007
      • Barcelona, Barcelona [Barcelona], Spain, 08036
        • Investigational Site Number : 7240005
      • L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain, 08908
        • Investigational Site Number : 7240001
    • Madrid, Comunidad de
      • Madrid / Madrid, Madrid, Comunidad de, Spain, 28040
        • Investigational Site Number : 7240009
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Investigational Site Number : 7240006
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Investigational Site Number : 7920008
      • Adana, Turkey (Türkiye), 01140
        • Investigational Site Number : 7920012
      • Adana, Turkey (Türkiye), 01250
        • Investigational Site Number : 7920002
      • Ankara, Turkey (Türkiye), 06800
        • Investigational Site Number : 7920011
      • Istanbul, Turkey (Türkiye), 34303
        • Investigational Site Number : 7920001
      • Istanbul, Turkey (Türkiye), 34214
        • Investigational Site Number : 7920005
      • Istanbul, Turkey (Türkiye), 34722
        • Investigational Site Number : 7920006
      • Izmir, Turkey (Türkiye)
        • Investigational Site Number : 7920007
      • Izmir, Turkey (Türkiye)
        • Investigational Site Number : 7920010
      • Kocaeli, Turkey (Türkiye), 41100
        • Investigational Site Number : 7920014
      • Malatya, Turkey (Türkiye)
        • Investigational Site Number : 7920009
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists South Division- Site Number : 8400020
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists North Division- Site Number : 8400019
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Ca & Hem Center Of W Michigan- Site Number : 8400016
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute Site Number : 8400011
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096-3411
        • Lankenau Hospital Cancer Center- Site Number : 8400017
    • Texas
      • El Paso, Texas, United States, 79915
        • Renovatio Clinical- Site Number : 8400032
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical - Site Number : 8400013
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin- Site Number : 8400006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR408701 (tusamitamab ravtansine)
Participants 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).
Drug: SAR408701
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
Active Comparator: Docetaxel
Participants 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).
Drug: Docetaxel
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
Other Names:
  • TAXOTERE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
PFS was defined as the time from the date of randomization to the date of the first documentation of objective PD as assessed by radiological review committee (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) definitions or death due to any cause before the study cut-off date, whichever occurred first. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
Overall Survival (OS)
Time Frame: From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks
Overall survival was defined as the time from date of randomization to date of death due to any cause.
From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
ORR was defined as the percentage of participants who had a complete response (CR) or partial response (PR), as best overall response derived from overall response (OR) determined by the IRC per RECIST 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
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)
Time Frame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
The TTD was defined as the time from baseline (Cycle 1, Day 1) until the first ≥10-point change from baseline up to the end of treatment assessment before the initiation of further anticancer therapy and the analysis cut-off date. For the TTD in disease-related symptoms (cough, dyspnea, pain) from EORTC QLQ LC-13, a deterioration was defined as an increase from baseline score of at least 10 points in any 1 of these 3 symptoms. The EORTC QLQ-LC13 (LC13) is the lung cancer module of the EORTC QLQ-C30 that assesses lung-cancer-associated symptoms (cough, dyspnea, pain, hemoptysis) and side-effects from conventional chemotherapy and radiotherapy (sore mouth, hair loss, dysphagia and neuropathy). The EORTC QLQ-LC13 contains 13 items. Items on the LC13 were scored using the LC13 scoring algorithms which standardize the raw scores to a 0-100 range. Lower scores indicate lower symptomology/symptom burden (lower scores better).
Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
TTD 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)
Time Frame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
TTD was defined as time from baseline(Cycle 1,Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date.For TTD in physical function from EORTC QLQ-C30, deterioration=decrease of at least 10 points from baseline score.EORTC QLQ-C30(C30) is 30-item, cancer specific that includes global health status/health-related quality of life(GHS/QoL), functional scales(physical,role,emotional,cognitive,social), symptom scales(fatigue,nausea&vomiting,pain), 5 symptom items(dyspnea,insomnia,appetite loss,constipation,diarrhea,perceived financial difficulties). Most questions from QLQ-C30 were rated on 4-point scale(1/Not at All to 4/Very Much), except Items 29-30,which comprise GHS scale and were rated on 7-point scale(1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0-100. High score represented favorable outcome with best quality of life.
Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
TTD in Role Function Measured by EORTC QLQ C30
Time Frame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
TTD was defined as time from baseline (Cycle 1, Day 1) until first ≥10-point change from baseline up to end of treatment assessment before initiation of further anticancer therapy and analysis cut-off date. For TTD in role function from EORTC QLQ-C30, deterioration = decrease of at least 10 points from baseline score. EORTC QLQ-C30 (C30) is a 30-item, cancer specific that includes GHS/QoL, functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, nausea & vomiting, pain), 5 symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, perceived financial difficulties item). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant.
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment period.
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
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Time Frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
Blood samples were collected to determine the abnormalities in hematology parameters.
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
Number of Participants With PCSA in Clinical Chemistry
Time Frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
Blood samples were collected to determine the clinical chemistry laboratory abnormalities.
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
Duration of Response (DOR)
Time Frame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
DOR was defined as the time from the date of first initial occurrence of a CR or PR to the date of first documentation of objective PD according to RECIST 1.1 before the initiation of any posttreatment anticancer therapy or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as unequivocal progression of existing non-target lesions; appearance of 1 or more new lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2020

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

April 16, 2026

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC15858 (Sanofi Identifier)
  • 2019-001273-81 (EudraCT Number)
  • U1111-1233-0781 (Registry Identifier: ICTRP)
  • 2024-515101-26-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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