Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Authorised, recruiting
Participants planned
460
Countries
7
Sites
31
Avanced Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Sep 2022 → ongoing
- Decision date (initial)
- 2023-07-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503795-24-00
- EudraCT number
- 2021-003022-77
- ClinicalTrials.gov
- NCT05099172
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Avanced Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
7 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 8 | 2 |
| France | Ongoing, recruitment ended | 21 | 7 |
| Italy | Ongoing, recruitment ended | 42 | 8 |
| Netherlands | Ongoing, recruitment ended | 10 | 3 |
| Poland | Ended | 6 | 2 |
| Portugal | Ongoing, recruiting | 6 | 2 |
| Spain | Ongoing, recruitment ended | 27 | 7 |
| Rest of world
Brazil, Korea, Republic of, Taiwan, Israel, Singapore, United States, China, Hong Kong, Japan
|
— | 340 | — |
Investigational sites
Institut Bergonie
Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire De Nantes
Oncologie médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Regional De Marseille
Centre d'Essais en Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Institut Curie
Institut du thorax, 26 Rue D Ulm, 75005, Paris
Institut Gustave Roussy
Département d’Innovation Thérapeutique et d’Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Oncologie Médicale, Boulevard Jacques Monod, 44805, Saint Herblain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia Polmonare, Regione Gonzole 10, 10043, Orbassano
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Humanitas Research Hospital
Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Parma
U.O. Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Centro Di Riferimento Oncologico Di Aviano
Tumori del Polmone e della Pleura, Via Franco Gallini 2, 33081, Aviano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità di Fase I - Farmacologia Clinica, Largo Francesco Vito 1, 00168, Rome
Centro Ricerche Cliniche Di Verona S.r.l.
Department of Engineering for Innovation Medicine, University of Verona, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
European Institute Of Oncology S.r.l.
Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Respiratory Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting Radboud universitair medisch centrum
Respiratory Medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Respiratory Medicine, Plesmanlaan 121, 1066 CX, Amsterdam
Uniwersyteckie Centrum Kliniczne
Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Oddział Kliniczny Pulmonologii Ogolnej i Onkologicznej, Ul. Stefana Zeromskiego 113, 90-549, Lodz
START Lisbon, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte E.P.E.
START Lisbon, Hospital de Santa Maria, CHULN, Av. Prof. Egas Moniz, 1649-035, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Victoria
IBIMA Phase 1 clinical trials unit, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-04-24 | 2023-04-28 | 2024-12-24 | ||
| France | 2023-03-28 | 2023-04-18 | 2024-12-24 | ||
| Italy | 2022-09-16 | 2022-11-03 | 2024-12-24 | ||
| Netherlands | 2023-04-25 | 2023-09-04 | 2024-12-24 | ||
| Poland | 2023-06-16 | ||||
| Portugal | 2023-08-23 | 2024-12-05 | |||
| Spain | 2022-10-11 | 2022-10-20 | 2024-12-24 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-21 | Netherlands | Acceptable 2023-07-26
|
2023-07-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-02 | Netherlands | Acceptable with conditions 2024-02-13
|
2024-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-06 | Netherlands | Acceptable 2024-06-10
|
2024-06-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-29 | Netherlands | Acceptable with conditions 2025-02-03
|
2025-02-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-21 | Acceptable with conditions | 2025-03-03 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-12 | Netherlands | Acceptable 2026-02-17
|
2026-02-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-10 | Netherlands | Acceptable 2026-04-22
|
2026-04-22 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-19 | Netherlands | Acceptable 2026-04-22
|
2026-05-19 |