Clinical trial • Phase I • Oncology
amivantamab for Advanced non-small cell lung cancer
Phase I trial of amivantamab for Advanced non-small cell lung cancer. open-label, none/not specified-controlled, adaptive. 652 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced non-small cell lung cancer
- Trial Stage
- Phase I
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 09-02-2024
- First CTIS Authorization Date
- 29-04-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 7 sites in Italy, France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation (first-in-human) design; specific adaptive rules (e.g. dose-escalation schema, interim analyses, stopping rules) not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 652
Recruitment
- Planned Sample Size
- 652
- Recruitment Window Months
- 83
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 8
Italy
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 648
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.S. Oncologia Medica Toraco-Polmonare
- Principal Investigator Name
- Filippo De Braud
- Principal Investigator Email
- filippo.debraud@istitutotumori.mi.it
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- filippo.debraud@istitutotumori.mi.it
France
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 641
- Number Of Sites
- 6
- Number Of Participants
- 7
Sites
- Site Name
- Institut Curie
- Department Name
- Thoracic oncology
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curis.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curis.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- MEDICAL ONCOLOGY
- Principal Investigator Name
- Benjamin Besse
- Principal Investigator Email
- benjamin.besse@gustaveroussy.fr
- Contact Person Name
- Benjamin Besse
- Contact Person Email
- benjamin.besse@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- ONCOLOGY AND THERAPEUTIC INNOVATIONS
- Principal Investigator Name
- Pascale Tomassini
- Principal Investigator Email
- pascale.tomasini@ap-hm.fr
- Contact Person Name
- Pascale Tomassini
- Contact Person Email
- pascale.tomasini@ap-hm.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncology
- 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
- Centre Leon Berard
- Department Name
- MEDICAL ONCOLOGY
- Principal Investigator Name
- Philippe Cassier
- Principal Investigator Email
- philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- MEDICAL ONCOLOGY
- Principal Investigator Name
- François Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Amivantamab (JNJ61186372)
- Active Substance
- amivantamab
- Modality
- Bispecific antibody
- First In Human
- Yes
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