Clinical trial • Phase III • Oncology
SACITUZUMAB GOVITECAN for Non-small cell lung cancer
Phase III trial of SACITUZUMAB GOVITECAN for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- ADC | Small molecule
Key dates
- Initial CTIS Submission Date
- 09-05-2024
- First CTIS Authorization Date
- 25-06-2024
Trial design
Randomised, open-label, docetaxel accord (docetaxel) — product name: docetaxel accord 20 mg/1 ml concentrate for solution for infusion; route: intravenous; listed max dose values in record: maxdailydoseamount 75 (doseuom: mg/kg) and maxtotaldoseamount 75; max treatment period 21 days.-controlled Phase III trial in Austria, Greece, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Docetaxel Accord (Docetaxel) — product name: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion; route: intravenous; listed max dose values in record: maxDailyDoseAmount 75 (doseUom: mg/kg) and maxTotalDoseAmount 75; max treatment period 21 days.
- Target Sample Size
- 197
Eligibility
Recruits 197 Participants must be 18 years of age or older and able to understand and give written informed consent (Inclusion criterion: "Participants assigned female at birth or participants assigned male at birth 18 years of age or older, able to understand and give written informed consent"). The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true) and ICFs/patient information are provided in multiple country-specific languages..
- Pregnancy Exclusion
- Positive serum pregnancy test (Appendix 11.4) or participants assigned female at birth who are lactating.
- Vulnerable Population
- Participants must be 18 years of age or older and able to understand and give written informed consent (Inclusion criterion: "Participants assigned female at birth or participants assigned male at birth 18 years of age or older, able to understand and give written informed consent"). The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true) and ICFs/patient information are provided in multiple country-specific languages.
Inclusion criteria
- {"criterion_text":"- Adequate hepatic function (bilirubin ≤ 1.5 upper limit of normal [ULN], aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 ULN if known liver metastases, and serum albumin > 3 g/dL). • Note: The investigator should follow local practice guidelines and/or the docetaxel label approved in the country of drug administration for assessing eligibility of patients for the study."}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix 11.6) before randomization"}
- {"criterion_text":"- Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 100,000/μL)."}
- {"criterion_text":"- Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}."}
- {"criterion_text":"- Participants assigned male at birth and participants assigned female patientsat birth of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.4."}
- {"criterion_text":"- Participants assigned female at birth or participants assigned male at birth 18 years of age or older, able to understand and give written informed consent"}
- {"criterion_text":"- Life expectancy of 3 months or more"}
- {"criterion_text":"- Pathologically documented NSCLC with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition)."}
- {"criterion_text":"- EGFR, ALK, and PD-L1 results are required prior to enrollment (see Section 6.3.10). Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For participants with squamous cell carcinoma, EGFR and ALK testing is optional."}
- {"criterion_text":"- Must have progressed after platinum-based chemotherapy in combination with anti- PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially. • Note: Includes patients who received prior platinum-based chemoradiotherapy (with or without maintenance anti-PD-1/PD-L1 antibody) for Stage 3 disease. To be considered to have progressed during or after prior treatment with platinum-based chemotherapy, patients should have either received prior platinum-based chemotherapy in the recurrent/ metastatic setting or have experienced disease progression within 6 months of last dose of platinum-based chemotherapy administered as part of concurrent chemoradiation for Stage 3 disease or as neoadjuvant or adjuvant therapy. To be considered to have progressed during or after prior treatment with an anti-PD-1/PD-L1 antibody, patients should have either received this therapy in the recurrent/metastatic setting or have experienced disease progression during “maintenance” treatment following concurrent chemoradiation for Stage 3 disease. a) No additional treatments are allowed in the recurrent/metastatic setting for patients with no actionable genomic alterations. b) Patients with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available TKI appropriate to the genomic alteration (see Appendix 8). c) Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC."}
- {"criterion_text":"- Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator."}
Exclusion criteria
- {"criterion_text":"- Patients who meet any of the following exclusion criteria at screening/Day −1 are not eligible to be enrolled in this study (no waivers for patient eligibility will be offered or permitted): Mixed small-cell lung cancer and NSCLC histology."}
- {"criterion_text":"- Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations."}
- {"criterion_text":"- Positive serum pregnancy test (Appendix 11.4) or participants assigned female at birth who are lactating."}
- {"criterion_text":"- Known hypersensitivity to the study drugs, their metabolites, or formulation excipients."}
- {"criterion_text":"- Requirement for ongoing therapy with or prior use of any prohibited medications for SG and docetaxel as per Sections 5.7.1 and 5.12, respectively."}
- {"criterion_text":"- Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from AEs at the time of study entry.Participants participating in observational studies are eligible."}
- {"criterion_text":"- Previously received treatment with any of the following: a) Topoisomerase 1 inhibitors. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase 1 b) Trop-2-targeted therapy c) Docetaxel as monotherapy or in combination with other agents"}
- {"criterion_text":"- NSCLC that is eligible for definitive local therapy alone."}
- {"criterion_text":"- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy."}
- {"criterion_text":"- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg/day or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability."}
- {"criterion_text":"- Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c) New York Heart Association Class III or greater congestive heart failure or left ventricular ejection fraction of less than 40%"}
- {"criterion_text":"- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal perforation within 6 months of enrollment"}
- {"criterion_text":"- Active serious infection requiring antibiotics."}
- {"criterion_text":"- Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism."}
- {"criterion_text":"- Positive for hepatitis B surface antigen. Participants who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease."}
- {"criterion_text":"- Positive hepatitis C antibody and detectable hepatitis C viral load."}
Endpoints
Primary endpoints
- {"endpoint_text":"- OS is defined as the time from the date of randomization until death due to any cause in the Intent-to-Treat (ITT) Analysis Set.","definition_or_measurement_approach":"OS is measured as time from randomization to death from any cause in the ITT Analysis Set."}
Secondary endpoints
- {"endpoint_text":"- PFS is defined as the time from the date of randomization until the date of objective disease progression or death (whichever comes first) as assessed by the investigator per RECIST Version 1.1.","definition_or_measurement_approach":"PFS measured from randomization to objective progression or death, assessed by investigator per RECIST v1.1."}
- {"endpoint_text":"- ORR is defined as the proportion of patientsparticipants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by the investigator per RECIST Version 1.1.","definition_or_measurement_approach":"ORR = proportion achieving CR or PR confirmed ≥4 weeks, per investigator assessment using RECIST v1.1."}
- {"endpoint_text":"- DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by the investigator per RECIST Version 1.1.","definition_or_measurement_approach":"DOR measured from first documented CR/PR to documented PD or death, per RECIST v1.1."}
- {"endpoint_text":"- DCR is defined as the proportion of patientsparticipants who achieve a CR, PR, or stable disease (SD) as assessed by the investigator per RECIST Version 1.1.","definition_or_measurement_approach":"DCR = proportion achieving CR, PR, or SD by investigator per RECIST v1.1."}
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities.","definition_or_measurement_approach":"Safety/tolerability assessed by incidence and severity of TEAEs and lab abnormalities."}
- {"endpoint_text":"- Time to first deterioration in shortness of breath domain as measured by NSCLC-SAQ.","definition_or_measurement_approach":"Time to first deterioration per NSCLC-SAQ shortness of breath domain."}
- {"endpoint_text":"- Time to first deterioration in NSCLC-SAQ total score.","definition_or_measurement_approach":"Time to first deterioration in total NSCLC-SAQ score."}
Recruitment
- Planned Sample Size
- 197
- Recruitment Window Months
- 47
- Consent Approach
- Written informed consent obtained from participants (must be ≥18 years and able to give written informed consent). Subject information and informed consent forms (including partner-pregnancy and optional future research forms) are provided in multiple country/language versions (examples in the public documents: German, Greek, Polish, Dutch, French, Portuguese, Italian, Spanish and other local language patient-facing documents as listed).
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 345
Austria
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Center for Clinical Cancer and Immunology Trials
- Principal Investigator Name
- Richard Greil
- Principal Investigator Email
- r.greil@salk.at
- Contact Person Name
- Richard Greil
- Contact Person Email
- r.greil@salk.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Innere Medizin und Pneumologie
- Principal Investigator Name
- Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@gesundheitsverbund.at
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
Greece
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 49
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Sofia Baka
- Principal Investigator Email
- bakasofia@hotmail.com
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
- Department Name
- Oncology Clinic of Clinical Trials and Research
- Principal Investigator Name
- Panagiotis Katsaounis
- Principal Investigator Email
- pkatsaounis.clinicaltrials@yahoo.com
- Contact Person Name
- Panagiotis Katsaounis
- Contact Person Email
- pkatsaounis.clinicaltrials@yahoo.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Oncology Department and Clinical Trials Unit
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 25
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Haemato-Oncology Hamburg Prof. Laack and Partner
- Department Name
- Haemato-Oncology Hamburg Prof. Laack and Partner
- Principal Investigator Name
- Eckart Laack
- Principal Investigator Email
- e.laack@haemato-onkologie-hh.de
- Contact Person Name
- Eckart Laack
- Contact Person Email
- e.laack@haemato-onkologie-hh.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Department of Thoracic Oncology
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Lungenfachklinik Immenhausen
- Department Name
- Pulmonary oncology, thoracic oncology, immunotherapy
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- s.brede@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- s.brede@lungenfachklinik-immenhausen.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Department of Cardiology, Angiology and Pulmonology
- Principal Investigator Name
- Martin Faehling
- Principal Investigator Email
- m.faehling@klinikum-esslingen.de
- Contact Person Name
- Martin Faehling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
Poland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 49
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
- Department Name
- Siedleckie Centrum Onkologii Oddział Onkologii Klinicznej i Radioterapii
- Principal Investigator Name
- Lubomir Bodnar
- Principal Investigator Email
- bbk@szpital.siedlce.pl
- Contact Person Name
- Lubomir Bodnar
- Contact Person Email
- bbk@szpital.siedlce.pl
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 52
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Afdeling Longoncologie
- Principal Investigator Name
- Lizza Hendriks
- Principal Investigator Email
- lizza.hendriks@mumc.nl
- Contact Person Name
- Lizza Hendriks
- Contact Person Email
- lizza.hendriks@mumc.nl
- Site Name
- Medical Center Haaglanden
- Department Name
- Afdeling Longoncologie
- Principal Investigator Name
- Klaar Maas
- Principal Investigator Email
- klaar.maas@haaglandenmc.nl
- Contact Person Name
- Klaar Maas
- Contact Person Email
- klaar.maas@haaglandenmc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Afdeling Longgeneeskunde
- Principal Investigator Name
- Robin Cornelissen
- Principal Investigator Email
- r.cornelissen@erasmusmc.nl
- Contact Person Name
- Robin Cornelissen
- Contact Person Email
- r.cornelissen@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 28-06-2024
- Processing Time Days
- 25
- Number Of Sites
- 12
- Number Of Participants
- 105
Sites
- Site Name
- Hopital Ambroise Pare
- Department Name
- Respiratory Diseases and Thoracic Oncology
- Principal Investigator Name
- Etienne Giroux Leprieur
- Principal Investigator Email
- etienne.giroux-leprieur@aphp.fr
- Contact Person Name
- Etienne Giroux Leprieur
- Contact Person Email
- etienne.giroux-leprieur@aphp.fr
- Site Name
- Institut Curie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Early Therapeutics Development Unit
- Principal Investigator Name
- Sandrine Hiret
- Principal Investigator Email
- sandrine.hiret@ico.unicancer.fr
- Contact Person Name
- Sandrine Hiret
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
- Site Name
- CHU Gabriel-Montpied
- Department Name
- Thoracic and Medical Oncology Department
- Principal Investigator Name
- Henri Janicot
- Principal Investigator Email
- hjanicot@chu-clermontferrand.fr
- Contact Person Name
- Henri Janicot
- Contact Person Email
- hjanicot@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pulmonology and Thoracic Oncology Department
- Principal Investigator Name
- Alexis Cortot
- Principal Investigator Email
- Alexis.CORTOT@chu-lille.fr
- Contact Person Name
- Alexis Cortot
- Contact Person Email
- Alexis.CORTOT@chu-lille.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Department of Oncology
- Principal Investigator Name
- Magali Ravoire
- Principal Investigator Email
- m.ravoire@isc84.org
- Contact Person Name
- Magali Ravoire
- Contact Person Email
- m.ravoire@isc84.org
- Site Name
- Clinique Victor Hugo
- Department Name
- Onco-Radiotherapy
- Principal Investigator Name
- Ossama Didas
- Principal Investigator Email
- essaisdidas@ilcgroupe.fr
- Contact Person Name
- Ossama Didas
- Contact Person Email
- essaisdidas@ilcgroupe.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Oncology
- Principal Investigator Name
- Radj Gervais
- Principal Investigator Email
- r.gervais@baclesse.fr
- Contact Person Name
- Radj Gervais
- Contact Person Email
- r.gervais@baclesse.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Pneumonology Department
- Principal Investigator Name
- Marie Marcq
- Principal Investigator Email
- marie.marcq@chd-vendee.fr
- Contact Person Name
- Marie Marcq
- Contact Person Email
- marie.marcq@chd-vendee.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Specialized Acute Pneumology and Thoracic Oncology Department
- Principal Investigator Name
- Sebastien Couraud
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sebastien Couraud
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Thoracic Oncology Unit
- Principal Investigator Name
- Jean-Louis Pujol
- Principal Investigator Email
- jl-pujol@chu-montpellier.fr
- Contact Person Name
- Jean-Louis Pujol
- Contact Person Email
- jl-pujol@chu-montpellier.fr
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jaafar Bennouna
- Principal Investigator Email
- j.bennouna@hopital-foch.com
- Contact Person Name
- Jaafar Bennouna
- Contact Person Email
- j.bennouna@hopital-foch.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 02-07-2024
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Champalimaud Clinical Centre
- Principal Investigator Name
- Nuno Gil
- Principal Investigator Email
- nuno.gil@fundacaochampalimaud.pt
- Contact Person Name
- Nuno Gil
- Contact Person Email
- nuno.gil@fundacaochampalimaud.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Hospital de dia Pneumologia Oncologica
- Principal Investigator Name
- Paula Alves
- Principal Investigator Email
- alvespaula57@gmail.com
- Contact Person Name
- Paula Alves
- Contact Person Email
- alvespaula57@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 35
- Number Of Sites
- 1
- Number Of Participants
- 27
Sites
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Hector Soto Parra
- Principal Investigator Email
- hsotoparra@policlinico.unict.it
- Contact Person Name
- Hector Soto Parra
- Contact Person Email
- hsotoparra@policlinico.unict.it
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 25-06-2024
- Processing Time Days
- 22
- Number Of Sites
- 8
- Number Of Participants
- 130
Sites
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Medical oncology Department
- Principal Investigator Name
- Ramon Palmero Sanchez
- Principal Investigator Email
- rpalmero@iconcologia.net
- Contact Person Name
- Ramon Palmero Sanchez
- Contact Person Email
- rpalmero@iconcologia.net
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Principal Investigator Name
- Manuel Cobo Dols
- Principal Investigator Email
- mangel.cobo.sspa@juntadeandalucia.es
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- mangel.cobo.sspa@juntadeandalucia.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Rosario Garcia Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Joaquim Bosch Barrera
- Principal Investigator Email
- jbosch@iconcologia.net
- Contact Person Name
- Joaquim Bosch Barrera
- Contact Person Email
- jbosch@iconcologia.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Dómine Gomez
- Principal Investigator Email
- ensayoscancerpulmonfjd@gmail.com
- Contact Person Name
- Manuel Dómine Gomez
- Contact Person Email
- ensayoscancerpulmonfjd@gmail.com
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Enric Carcereny Costa
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jon Zugazagoitia Fraile
- Principal Investigator Email
- j.zugazagoitia.imas12@h12o.es
- Contact Person Name
- Jon Zugazagoitia Fraile
- Contact Person Email
- j.zugazagoitia.imas12@h12o.es
- Site Name
- Antwerp University Hospital (site listed under Spain block as part of dataset)
- Department Name
- Medical oncology Department
- Principal Investigator Name
- Reinier Wener
- Principal Investigator Email
- iris.verhaegen@uza.be
- Contact Person Name
- Reinier Wener
- Contact Person Email
- iris.verhaegen@uza.be
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 27-06-2024
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Reinier Wener
- Principal Investigator Email
- iris.verhaegen@uza.be
- Contact Person Name
- Reinier Wener
- Contact Person Email
- iris.verhaegen@uza.be
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research LLC
- Responsibilities
- Monitoring, Regulatory (e.g. preparation of applications to CA and ethics committee), Investigator recruitment, SUSAR reporting
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- codes: 1,12,13,2,4,5,8
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical haematology, Serology/ endocrinology, Analytical chemistry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 6, 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Monitoring, Regulatory (e.g. preparation of applications to CA and ethics committee), Investigator recruitment, SUSAR reporting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"codes: 1,12,13,2,4,5,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Clinical haematology, Serology/ endocrinology , Analytical chemistry","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Trodelvy 200 mg powder for concentrate for solution for infusion
- Active Substance
- SACITUZUMAB GOVITECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation: EU/1/21/1592/001
- Frequency
- Every 21 days (max treatment period 21 days as listed)
- Maximum Dose
- 20 mg/kg (maxTotalDoseAmount = 20, doseUom: mg/kg)
- Investigational Product Name
- Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation: EU/1/12/769/001
- Frequency
- Every 21 days (max treatment period 21 days as listed)
- Maximum Dose
- 75 mg/kg (maxDaily/TotalDoseAmount = 75, doseUom: mg/kg)
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