Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
885
Countries
7
Sites
53
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 8 Oct 2024 → ongoing
- Decision date (initial)
- 2025-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514304-14-00
- WHO UTN
- U1111-1303-1076
- ClinicalTrials.gov
- NCT06311721
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
7 EU/EEA countries · 53 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 12 | 3 |
| Bulgaria | Ongoing, recruiting | 7 | 3 |
| France | Ongoing, recruiting | 14 | 9 |
| Germany | Ended | 30 | 7 |
| Italy | Ongoing, recruiting | 53 | 9 |
| Poland | Ongoing, recruiting | 60 | 6 |
| Spain | Ongoing, recruiting | 57 | 16 |
| Rest of world
Japan, Argentina, Philippines, Serbia, Turkey, Georgia, Thailand, Chile, Brazil, United States, Peru, United Kingdom, Korea, Republic of, Malaysia, Mexico, Taiwan
|
— | 652 | — |
Investigational sites
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department of pulmonary diseases, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Ordensklinikum Linz GmbH
Pneumology, Fadingerstrasse 1, 4020, Linz
Klinik Hietzing
Klinik Hietzing 5. Med. Abteilung Pavillon 3, Wolkersbergenstrasse 1, Hietzing, Vienna
Multiprofile Hospital For Active Treatment Dobrich AD
Department of Medical Oncology, Ulitsa Panayot Hitov 24, 9300, Dobrich
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Medical Oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
UMHAT Sofiamed OOD
Department of Medical Oncology, Bulevard D-R G.m.dimitrov 16, 1797, Sofiya
Hopital Europeen Marseille
Pneumology, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier Et Universitaire De Limoges
Pneumology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Assoc Hospitaliere Nord Artois Clinique
Pneumology, 118 Avenue Desandrouin, 59300, Valenciennes
Hopitaux Prives De Metz
Pneumology, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Pneumology, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Centre De Cancerologue Du Grand Montpellier
Pneumology, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Universitaire De Nantes
Oncology thoracic Unit, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Nimes
Oncology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Klinik Hämatologie, Onkologie und Nephrologie, Friesenstrasse 11, Innenstadt, Neumuenster
Klinikum St Marien Amberg
N/A, Mariahilfbergweg 7, 92224, Amberg
Klinikum Aschaffenburg-Alzenau gGmbH
N/A, Am Hasenkopf 1, Innenstadt, Aschaffenburg
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie &Onkologische Palliativmedizin, Henricistrasse 92, Huttrop, Essen
Justus-Liebig-Universitaet Giessen
Hämatologie und Internistische Onkologie, Gaffkystrasse 5, 35392, Giessen
Dr. Vehling-Kaiser MVZ GmbH
N/A, Achdorfer Weg 5, Achdorf, Landshut
Onkologie UnterEms
N/A, Annenstr. 11, 26789, Leer
University Hospital Of Ferrara
UO Oncologia, Cona, Via Aldo Moro 8, Ferrara
Azienda Sanitaria Locale Napoli 1 Centro
UOC Oncologia, Via Enrico Russo 1, 80147, Naples
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario
SC Oncologia Medica, Via Stelvio N 25, 23100, Sondrio
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia Medica, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Unita Sanitaria Locale Della Romagna
UO Oncologia, Dipartimento Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
San Camillo Forlanini Hospital
UOSD Pneumo- oncologia, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Socio Sanitaria Territoriale Di Cremona
Oncologia, Viale Concordia 1, 26100, Cremona
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Oncologia Medica, Via Della Commenda 12, 20122, Milan
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Oncoematologia, Via Sergio Pansini 5, 80131, Naples
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii I, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddział Onkologii Klinicznej, Chemioterapii, Ul. Hubalczykow 1, 76-200, Slupsk
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
N/A, Ul. Polnocna 8/3, 20-064, Lublin
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddzial Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorob Wewnetrznych, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Med Polonia Sp. z o.o.
not applicable/nie dotyczy, Obornicka 262, 60-693, Poznan
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial onkologii z pododdzialem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Micancer Center S.L.P.
Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital General Universitario De Elche
Oncology, Edificio 2, Camino De La Almazara 11, Elche
Hospital Quironsalud Valencia
Oncology, Avenida Blasco Ibanez 14, 46010, Valencia
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Fundacion Alcorcon
Oncology, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Clinico Universitario De Valladolid
Oncology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Instituto Multidisciplinar De Oncologia S.A.
Oncology, Calle De Joaquin Costa 28, 28002, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Consorci Sanitari Del Maresme
Oncology, Carretera De Cirera 230, 08304, Mataro
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
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 |
|---|---|---|---|---|---|
| Austria | 2025-04-08 | 2025-07-01 | |||
| Bulgaria | 2024-10-28 | 2025-02-04 | |||
| France | 2024-10-14 | 2025-02-12 | |||
| Germany | 2024-11-05 | ||||
| Italy | 2025-01-16 | 2025-08-25 | |||
| Poland | 2024-10-16 | 2025-02-18 | |||
| Spain | 2024-10-08 | 2024-10-17 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Spain | Acceptable 2024-09-23
|
2024-09-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-25 | Spain | Acceptable | 2024-11-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-25 | Acceptable | 2024-12-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-28 | Acceptable | 2024-12-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-29 | Acceptable | 2024-12-03 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-29 | Acceptable | 2025-02-07 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-10-30 | Acceptable 2024-09-23
|
2025-02-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-18 | Spain | Acceptable 2025-07-17
|
2025-07-17 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-15 | Spain | Acceptable 2026-02-02
|
2026-02-03 |