Clinical trial • Phase III • Oncology
lazertinib for Advanced Non-small cell lung cancer|Non-small cell lung cancer
Phase III trial of lazertinib for Advanced Non-small cell lung cancer|Non-small cell lung cancer. 495 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced Non-small cell lung cancer|Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 25-01-2024
- First CTIS Authorization Date
- 13-03-2024
Trial design
Phase III trial across 13 sites in Germany, France, Spain and others.
- Target Sample Size
- 495
Eligibility
Recruits 495 Vulnerable population selected; no details on consent or assent handling are provided in the available records..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling are provided in the available records.
Recruitment
- Planned Sample Size
- 495
- Recruitment Window Months
- 89
- Consent Approach
- Not specified; vulnerable population selected but no consent/assent details available
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 495
Germany
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 791
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Oncology
- Contact Person Name
- Marcel Wiesweg
- Contact Person Email
- marcel.wiesweg@uk-essen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Oncology
- Contact Person Name
- Sebastian Michels
- Contact Person Email
- sebastian.michels@uk-koeln.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Oncology
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- Frank.Griesinger@Pius-Hospital.de
France
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 791
- Number Of Sites
- 5
- Number Of Participants
- 87
Sites
- Site Name
- Direction Centrale Du Service De Sante Des Armees
- Department Name
- ONCOLOGY
- Contact Person Name
- Hugo PICCHI
- Contact Person Email
- picchi.hugo90@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- MEDICAL ONCOLOGY
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Thoracic oncology
- Contact Person Name
- Nicolas GIRARD
- Contact Person Email
- nicolas.girard2@curis.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- ONCOLOGY AND THERAPEUTIC INNOVATIONS
- Contact Person Name
- Pascale TOMASINI
- Contact Person Email
- pascale.tomasini@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- MEDICAL ONCOLOGY
- Contact Person Name
- Benjamin BESSE
- Contact Person Email
- benjamin.besse@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 795
- Number Of Sites
- 3
- Number Of Participants
- 67
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Reyes Bernabe Caro
- Contact Person Email
- bernabeensayos@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 791
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Unità Clinica di Fase I, SC Sperimentazioni Cliniche
- Contact Person Name
- Adriano Gravina
- Contact Person Email
- a.gravina@istitutotumori.na.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Oncologia Medica Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovativee
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-73841937 (Lazertinib)
- Active Substance
- lazertinib
- Modality
- Small molecule
- Investigational Product Name
- JNJ-61186372
- Active Substance
- bispecific EGFR and cMet antibody
- Modality
- Bispecific antibody
- Combination Treatment
- Yes
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