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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1233-0781 | Registry Identifier | ICTRP | |
| 2024-515101-26-00 | Registry Identifier | CTIS | |
| 2019-001273-81 | EudraCT Number |
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Sponsor decision, the decision is not related to any safety concern.
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Primary Objectives:
Secondary Objectives:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR408701 (tusamitamab ravtansine) | Experimental | 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). |
|
| Docetaxel | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR408701 | Drug | Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks |
| Overall Survival (OS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists South Division- Site Number : 8400020 | Fort Myers | Florida | 33901 | United States | ||
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| Label | URL |
|---|---|
| EFC15858 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 490 participants were screened, of which 389 participants were randomized in a ratio of 1:1 to either tusamitamab ravtansine or docetaxel arm. The randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1), previous immune checkpoint inhibitor treatment (sequential versus combination with chemotherapy) and geographical region (Asia versus Western Europe + Australia + North America versus Rest of the World [RoW]).
The study was conducted at 161 centers in 25 countries from 06 February 2020 to 22 September 2023 (primary completion date). Results are reported as per the primary completion date of 22 September 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2023 | Sep 12, 2024 |
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| Docetaxel | Drug | Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion |
|
|
| 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) | 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) | 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 | 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) | 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 | 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 | 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) | 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 |
| Florida Cancer Specialists North Division- Site Number : 8400019 |
| St. Petersburg |
| Florida |
| 33705 |
| United States |
| Ca & Hem Center Of W Michigan- Site Number : 8400016 | Grand Rapids | Michigan | 49546 | United States |
| Roswell Park Cancer Institute Site Number : 8400011 | Buffalo | New York | 14263-0001 | United States |
| Lankenau Hospital Cancer Center- Site Number : 8400017 | Wynnewood | Pennsylvania | 19096-3411 | United States |
| Renovatio Clinical- Site Number : 8400032 | El Paso | Texas | 79915 | United States |
| Renovatio Clinical - Site Number : 8400013 | The Woodlands | Texas | 77380 | United States |
| Medical College of Wisconsin- Site Number : 8400006 | Milwaukee | Wisconsin | 53226 | United States |
| Investigational Site Number : 0320009 | CABA | Buenos Aires | C1019ABS | Argentina |
| Investigational Site Number : 0320012 | Capital Federal | Buenos Aires | 1012 | Argentina |
| Investigational Site Number : 0320003 | Viedma | Río Negro Province | R8500ACE | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1426ANZ | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | C1125ABD | Argentina |
| Investigational Site Number : 0320014 | Córdoba | ZCX5000AAI | Argentina |
| Investigational Site Number : 0320002 | Salta | 4400 | Argentina |
| Investigational Site Number : 0360002 | Blacktown | New South Wales | 2148 | Australia |
| Investigational Site Number : 0360003 | Waratah | New South Wales | 2298 | Australia |
| Investigational Site Number : 0360001 | Woolloongabba | Queensland | 4102 | Australia |
| Investigational Site Number : 0560006 | Anderlecht | 1070 | Belgium |
| Investigational Site Number : 0560004 | Edegem | B-2650 | Belgium |
| Investigational Site Number : 0560005 | Ghent | 9000 | Belgium |
| Investigational Site Number : 0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number : 0560003 | Liège | 4000 | Belgium |
| Investigational Site Number : 0560002 | Woluwe-Saint-Lambert | 1200 | Belgium |
| Centro Regional Integrado De Oncologia - CRIO- Site Number : 0760002 | Fortaleza | Ceará | 60336-232 | Brazil |
| ~Instituto De Oncologia Parana- Site Number : 0760008 | Curitiba | Paraná | 80530-010 | Brazil |
| Centro Avancado de Oncologia CECAN - Liga Contra o Cancer- Site Number : 0760026 | Natal | Rio Grande do Norte | 59062-000 | Brazil |
| Clínica de Oncologia Reichow Site Number : 0760023 | Blumenau | Santa Catarina | 89010-340 | Brazil |
| Hospital de Base Sao Jose do Rio Preto Site Number : 0760001 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital Sirio Libanes- Site Number : 0760018 | São Paulo | São Paulo | 01308050 | Brazil |
| Investigational Site Number : 1000008 | Burgas | 8000 | Bulgaria |
| Investigational Site Number : 1000010 | Pleven | 5800 | Bulgaria |
| Investigational Site Number : 1000007 | Plovdiv | 4002 | Bulgaria |
| Investigational Site Number : 1000004 | Sofia | 1330 | Bulgaria |
| Investigational Site Number : 1000003 | Sofia | 1618 | Bulgaria |
| Investigational Site Number : 1000001 | Sofia | 1797 | Bulgaria |
| Investigational Site Number : 1240003 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Investigational Site Number : 1240010 | Montreal | Quebec | H1T 1P7 | Canada |
| Investigational Site Number : 1520007 | Santiago | Reg Metropolitana de Santiago | 7500713 | Chile |
| Investigational Site Number : 1520006 | Santiago | Reg Metropolitana de Santiago | 7500921 | Chile |
| Investigational Site Number : 1520009 | Santiago | Reg Metropolitana de Santiago | 7650568 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520001 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Investigational Site Number : 1560026 | Beijing | 100142 | China |
| Investigational Site Number : 1560009 | Changchun | 130012 | China |
| Investigational Site Number : 1560010 | Changchun | 130021 | China |
| Investigational Site Number : 1560015 | Changsha | 410006 | China |
| Investigational Site Number : 1560039 | Changsha | 410011 | China |
| Investigational Site Number : 1560032 | Chengdu | 610041 | China |
| Investigational Site Number : 1560038 | Chengdu | 610041 | China |
| Investigational Site Number : 1560044 | Chongqing | 400038 | China |
| Investigational Site Number : 1560043 | Chongqing | 400042 | China |
| Investigational Site Number : 1560024 | Fuzhou | 350008 | China |
| Investigational Site Number : 1560001 | Guangzhou | 510080 | China |
| Investigational Site Number : 1560036 | Guangzhou | 510095 | China |
| Investigational Site Number : 1560037 | Guangzhou | 510163 | China |
| Investigational Site Number : 1560017 | Guangzhou | 510515 | China |
| Investigational Site Number : 1560025 | Hangzhou | 310003 | China |
| Investigational Site Number : 1560033 | Hangzhou | 310009 | China |
| Investigational Site Number : 1560021 | Hangzhou | 310014 | China |
| Investigational Site Number : 1560011 | Hangzhou | 310022 | China |
| Investigational Site Number : 1560005 | Harbin | 150081 | China |
| Investigational Site Number : 1560050 | Huizhou | 516001 | China |
| Investigational Site Number : 1560047 | Jinan | 250013 | China |
| Investigational Site Number : 1560023 | Nanjing | 210006 | China |
| Investigational Site Number : 1560019 | Nanjing | 210009 | China |
| Investigational Site Number : 1560012 | Nanning | 530021 | China |
| Investigational Site Number : 1560045 | Tianjin | 300060 | China |
| Investigational Site Number : 1560006 | Wuhan | 430079 | China |
| Investigational Site Number : 1560016 | Zhanjiang | 524001 | China |
| Investigational Site Number : 1560041 | Zhengzhou | 450003 | China |
| Investigational Site Number : 1560040 | Zhengzhou | 450008 | China |
| Investigational Site Number : 2500010 | Bordeaux | 33076 | France |
| Investigational Site Number : 2500008 | Caen | 14076 | France |
| Investigational Site Number : 2500006 | Créteil | 94010 | France |
| Investigational Site Number : 2500007 | Grenoble | 38043 | France |
| Investigational Site Number : 2500001 | Marseille | 13015 | France |
| Investigational Site Number : 2500013 | Montpellier | 34295 | France |
| Investigational Site Number : 2500011 | Paris | 75231 | France |
| Investigational Site Number : 2500014 | Paris | 75970 | France |
| Investigational Site Number : 2500009 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500003 | Rennes | 35033 | France |
| Investigational Site Number : 2500012 | Saint-Herblain | 44800 | France |
| Investigational Site Number : 2500002 | Saint-Mandé | 94160 | France |
| Investigational Site Number : 2500004 | Villejuif | 94800 | France |
| Investigational Site Number : 2760002 | Essen | 45147 | Germany |
| Investigational Site Number : 2760001 | Heidelberg | 69126 | Germany |
| Investigational Site Number : 3000005 | Athens | 11526 | Greece |
| Investigational Site Number : 3000001 | Athens | 11527 | Greece |
| Investigational Site Number : 3000003 | Heraklion | 71500 | Greece |
| Investigational Site Number : 3000004 | Ioannina | 455 00 | Greece |
| Investigational Site Number : 3000006 | Thessaloniki | 54645 | Greece |
| Investigational Site Number : 3480003 | Budapest | 1121 | Hungary |
| Investigational Site Number : 3480007 | Budapest | 1125 | Hungary |
| Investigational Site Number : 3480005 | Kaposvár | 7400 | Hungary |
| Investigational Site Number : 3760001 | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760002 | Kfar Saba | 44281 | Israel |
| Investigational Site Number : 3760003 | Petah Tikva | 49100 | Israel |
| Investigational Site Number : 3800004 | Ravenna | Emilia-Romagna | 48121 | Italy |
| Investigational Site Number : 3800005 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800003 | Orbassano | Torino | 10043 | Italy |
| Investigational Site Number : 3800006 | Catania | Italy |
| Investigational Site Number : 3800001 | Milan | 20133 | Italy |
| Investigational Site Number : 3920002 | Nagoya | Aichi-ken | 460-0001 | Japan |
| Investigational Site Number : 3920015 | Nagoya | Aichi-ken | 464-8681 | Japan |
| Investigational Site Number : 3920012 | Fukuoka | Fukuoka | 810-8563 | Japan |
| Investigational Site Number : 3920008 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Investigational Site Number : 3920016 | Sapporo | Hokkaido | 003-0804 | Japan |
| Investigational Site Number : 3920017 | Himeji-shi | Hyōgo | 670-8520 | Japan |
| Investigational Site Number : 3920006 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Investigational Site Number : 3920005 | Yokohama | Kanagawa | 241-8515 | Japan |
| Investigational Site Number : 3920009 | Natori-shi | Miyagi | 981-1293 | Japan |
| Investigational Site Number : 3920001 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Investigational Site Number : 3920003 | Osaka | Osaka | 541-8567 | Japan |
| Investigational Site Number : 3920013 | Osaka Sayama-shi | Osaka | 589-8511 | Japan |
| Investigational Site Number : 3920004 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Investigational Site Number : 3920011 | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Investigational Site Number : 3920018 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Investigational Site Number : 3920007 | Wakayama | Wakayama | 641-8510 | Japan |
| Investigational Site Number : 3920010 | Ube-shi | Yamaguchi | 755-0241 | Japan |
| Investigational Site Number : 4840003 | Cuauhtémoc | Mexico City | 06700 | Mexico |
| Investigational Site Number : 5280003 | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Investigational Site Number : 5280004 | Breda | 4818 CK | Netherlands |
| Investigational Site Number : 5280005 | Utrecht | 3543 AZ | Netherlands |
| Investigational Site Number : 6160004 | Olsztyn | Warmian-Masurian Voivodeship | 10-357 | Poland |
| Investigational Site Number : 6160001 | Warsaw | 02-781 | Poland |
| Investigational Site Number : 6200002 | Almada | 2801-951 | Portugal |
| Investigational Site Number : 6200001 | Lisbon | 1769 | Portugal |
| Investigational Site Number : 6200004 | Lisbon | 1998-018 | Portugal |
| Investigational Site Number : 6200005 | Porto | 4099-001 | Portugal |
| Investigational Site Number : 6200006 | Porto | 4100-180 | Portugal |
| Investigational Site Number : 6420008 | Alba Iulia | 510077 | Romania |
| Investigational Site Number : 6420009 | Brasov | 500152 | Romania |
| Investigational Site Number : 6420003 | Bucaresti | 022328 | Romania |
| Investigational Site Number : 6420010 | Cluj-Napoca | 400124 | Romania |
| Investigational Site Number : 6420011 | Cluj-Napoca | 407280 | Romania |
| Investigational Site Number : 6420012 | Otopeni | 75100 | Romania |
| Investigational Site Number : 6420005 | Timișoara | 300166 | Romania |
| Investigational Site Number : 6430001 | Moscow | 115478 | Russia |
| Investigational Site Number : 6430003 | Saint Petersburg | 197758 | Russia |
| Investigational Site Number : 7020001 | Singapore | 308433 | Singapore |
| Investigational Site Number : 7020002 | Singapore | 329563 | Singapore |
| Investigational Site Number : 4100008 | Busan | Busan | 48108 | South Korea |
| Investigational Site Number : 4100005 | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100007 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 4100003 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number : 4100004 | Seoul | Seoul-teukbyeolsi | 07061 | South Korea |
| Investigational Site Number : 4100001 | Seoul | 06591 | South Korea |
| Investigational Site Number : 7240007 | Barcelona | Barcelona [Barcelona] | 08028 | Spain |
| Investigational Site Number : 7240005 | Barcelona | Barcelona [Barcelona] | 08036 | Spain |
| Investigational Site Number : 7240001 | L'Hospitalet de Llobregat | Barcelona [Barcelona] | 08908 | Spain |
| Investigational Site Number : 7240009 | Madrid / Madrid | Madrid, Comunidad de | 28040 | Spain |
| Investigational Site Number : 7240006 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number : 7240002 | Madrid | 28041 | Spain |
| Investigational Site Number : 7240004 | Málaga | 29010 | Spain |
| Investigational Site Number : 7240011 | Seville | 41013 | Spain |
| Investigational Site Number : 7240008 | Valencia | 46026 | Spain |
| Investigational Site Number : 7920008 | Adana | 01060 | Turkey (Türkiye) |
| Investigational Site Number : 7920012 | Adana | 01140 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Adana | 01250 | Turkey (Türkiye) |
| Investigational Site Number : 7920011 | Ankara | 06800 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Istanbul | 34214 | Turkey (Türkiye) |
| Investigational Site Number : 7920001 | Istanbul | 34303 | Turkey (Türkiye) |
| Investigational Site Number : 7920006 | Istanbul | 34722 | Turkey (Türkiye) |
| Investigational Site Number : 7920007 | Izmir | Turkey (Türkiye) |
| Investigational Site Number : 7920010 | Izmir | Turkey (Türkiye) |
| Investigational Site Number : 7920014 | Kocaeli | 41100 | Turkey (Türkiye) |
| Investigational Site Number : 7920009 | Malatya | Turkey (Türkiye) |
| FG001 | 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). |
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized participants consisted of all participants with a signed main study informed consent form who had a treatment kit number allocated and recorded in the interactive response technology (IRT) database, regardless of whether the treatment kit was used or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tusamitamab Ravtansine | Participants received tusamitamab ravtansine 100 mg/m^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks). |
| BG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | The intent-to-treat (ITT) population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks |
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| Primary | Overall Survival (OS) | Overall survival was defined as the time from date of randomization to date of death due to any cause. | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | Posted | Median | 95% Confidence Interval | months | From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | Posted | Median | 95% Confidence Interval | months | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | Posted | Median | 95% Confidence Interval | months | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. | Posted | Median | 95% Confidence Interval | months | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2027 | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters | Blood samples were collected to determine the abnormalities in hematology parameters. | Not Posted | Aug 2027 | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With PCSA in Clinical Chemistry | Blood samples were collected to determine the clinical chemistry laboratory abnormalities. | Not Posted | Aug 2027 | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The ITT population consisted of all participants who had given their informed consent and who had a treatment kit number allocated and recorded in the IRT database. Only participants with randomization date ≥8 weeks prior to analysis cut-off date or with early PD prior to the cut-off date are reported. | Posted | Median | 95% Confidence Interval | months | Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks |
|
TEAEs were collected 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. All-cause mortality data was collected from date of first study treatment administration (Day 1) until the primary analysis date of 22 September 2023 (up to 189 weeks).
Analysis was performed on safety population. All-cause mortality data was collected on randomized population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tusamitamab Ravtansine | Participants received tusamitamab ravtansine 100 mg/m^2 by IV infusion, once Q2W until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks). | 109 | 194 | 55 | 194 | 159 | 194 |
| EG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). | 110 | 195 | 68 | 177 | 151 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDra 26.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDra 26.0 | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Colitis Ischaemic | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Mechanical Ileus | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Obstruction Gastric | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Oesophageal Stenosis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Neutropenic Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia Influenzal | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Compression Fracture | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Troponin T Increased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Intracranial Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Malignant Pleural Effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Pericardial Effusion Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Intracranial Pressure Increased | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Malignant Spinal Cord Compression | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDra 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Keratopathy | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2023 | Sep 12, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000720449 | tusamitamab ravtansine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Not reported |
|
| Unknown |
|
|
|
|
|
|
|
| OG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). |
|
|
|
| OG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). |
|
|
|
| OG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). |
|
|
|
| OG001 | Docetaxel | Participants received docetaxel 75 mg/m^2 by IV infusion, once 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). |
|
|