Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
155
Countries
7
Sites
59
Early-stage 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
- 5 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508359-38-00
- WHO UTN
- U1111-1301-6784
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Early-stage 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 |
| 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 · 59 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 5 | 1 |
| France | Ongoing, recruitment ended | 9 | 7 |
| Germany | Ongoing, recruitment ended | 12 | 2 |
| Italy | Ongoing, recruitment ended | 13 | 13 |
| Poland | Ended | 19 | 6 |
| Romania | Ongoing, recruitment ended | 1 | 5 |
| Spain | Ongoing, recruitment ended | 25 | 25 |
| Rest of world
Thailand, Philippines, Georgia, Taiwan, Chile, Mexico, Malaysia, Serbia, Korea, Republic of
|
— | 71 | — |
Investigational sites
UMHAT Sofiamed OOD
Department of Medical Oncology, Bulevard D-R G.m.dimitrov 16, 1797, Sofiya
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Service d’Oncologie, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Centre Francois Baclesse
NA, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Hopitaux Prives De Metz
Pulmonology department, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Centre Hospitalier Universitaire De Bordeaux
Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Hôpital de jour d’oncologue thoracique, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Hopital Europeen Marseille
Service des Maladies Respiratoires, 6 Rue Desiree Clary, 13003, Marseille
Ramsay Generale De Sante
Oncology, 2 Allee Docteur Robert Lafon, 64100, Bayonne
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
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia Medica, Viale Tristano Di Joannuccio 1, 05100, Terni
Cliniche Gavazzeni S.p.A.
Humanitas Gavazzeni, Via Mauro Gavazzeni 21, 24125, Bergamo
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
U O Oncologia Toracica, Via Monte Baldo 24, 37019, Peschiera Del Garda
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Dipartimentico di Oncologia, Viale Luigi Borri 57, 21100, Varese
Azienda Ospedaliera Santa Croce E Carle
Oncology Department, Via Michele Coppino 26, 12100, Cuneo
University Hospital Of Ferrara
UO Oncologia, Cona, Via Aldo Moro 8, Ferrara
Azienda Unita Sanitaria Locale Della Romagna
UO Oncologia, Dipartimento Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
Careggi University Hospital
SODc Clinical Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Locale Napoli 1 Centro
UOC Oncologia, Via Enrico Russo 1, 80147, Naples
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Oncology division, Via Guglielmo Lippi Francesconi 556, 55100, Lucca
Humanitas Mirasole S.p.A.
Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Cagliari
UOC Oncologia, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
UOC Oncologia Medica, Via Aurelia 335, 55041, Camaiore
Gyncentrum Sp. z o.o.
Gyncentrum - Szpital, Ul. Wojska Polskiego 8a, 41-208, Sosnowiec
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii, Ul. Monte Cassino 18, 37-700, Peremyshl
Specjalistyczne Gabinety Sp. z o.o.
N/A, Pl. Lasoty 4, 30-539, Cracow
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial onkologii z pododdzialem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddzial Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorob Wewnetrznych, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii I, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Micancer Center S.L.P.
Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Oncology, Rua Doctor Camilo Veiras 1, 15009, A Coruna
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Instituto Multidisciplinar De Oncologia S.A.
Oncology, Calle De Joaquin Costa 28, 28002, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Fundacion Alcorcon
Oncology, Calle Budapest 1, 28022, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital General Universitario De Elche
Oncology, Edificio 2, Camino De La Almazara 11, Elche
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 Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Consorci Sanitari Del Maresme
Oncology, Carretera De Cirera 230, 08304, Mataro
Hospital Clinico Universitario De Valladolid
Oncology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Dr Peset Aleixandre
Oncology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-06-05 | ||||
| France | 2024-10-08 | 2024-10-08 | 2026-03-23 | ||
| Germany | 2024-07-10 | 2025-09-18 | 2026-03-23 | ||
| Italy | 2025-01-25 | 2025-07-15 | 2026-03-23 | ||
| Poland | 2024-12-17 | 2024-12-17 | 2026-03-23 | ||
| Romania | 2024-11-20 | 2024-11-20 | 2026-03-23 | ||
| Spain | 2024-08-05 | 2024-08-05 | 2026-03-23 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Spain | Acceptable 2024-05-29
|
2024-05-31 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-06-14 | Acceptable 2024-05-29
|
2024-09-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-21 | Acceptable | 2024-09-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-21 | Acceptable | 2024-07-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-25 | Spain | Acceptable | 2024-08-21 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-05 | Acceptable | 2024-08-02 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-08 | Acceptable | 2024-08-20 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-08 | Acceptable | 2024-09-27 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-31 | Spain | Acceptable 2025-01-17
|
2025-01-22 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-26 | Acceptable 2025-01-17
|
2025-02-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-05-16 | Spain | Acceptable 2025-08-19
|
2025-08-20 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-30 | Spain | Acceptable 2025-11-27
|
2025-11-28 |