Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
503
Countries
9
Sites
58
advanced/metastatic non-squamous non-small cell lung cancer (NSCLC)
Key facts
- Sponsor
- Mabxience Research S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Sep 2025 → ongoing
- Decision date (initial)
- 2025-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515853-48-00
- ClinicalTrials.gov
- NCT06687369
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
advanced/metastatic non-squamous non-small cell lung cancer (NSCLC)
| 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
Mabxience Research S.L.
- Sponsor organisation
- Mabxience Research S.L.
- Address
- Calle De Manuel Pombo Angulo 28
- City
- Madrid
- Postcode
- 28050
- Country
- Spain
Scientific contact point
- Organisation
- Mabxience Research S.L.
- Contact name
- Susana Millán
Public contact point
- Organisation
- Mabxience Research S.L.
- Contact name
- Susana Millán
Locations
9 EU/EEA countries · 58 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ended | 13 | 2 |
| Germany | Ended | 10 | 3 |
| Greece | Authorised, recruiting | 18 | 9 |
| Italy | Authorised, recruiting | 15 | 10 |
| Poland | Authorised, recruiting | 7 | 5 |
| Portugal | Authorised, recruitment pending | 5 | 4 |
| Romania | Authorised, recruiting | 8 | 6 |
| Slovakia | Authorised, recruiting | 5 | 3 |
| Spain | Authorised, recruiting | 30 | 16 |
| Rest of world
Japan, Malaysia, Korea, Republic of, Bosnia and Herzegovina, Moldova, Republic of, Tunisia, Turkey, Peru, Brazil, Saudi Arabia, Philippines, Armenia, Pakistan, Taiwan, Mexico, Jordan, Georgia, Panama, Thailand, Serbia, South Africa
|
— | 392 | — |
Investigational sites
Klinicki bolnicki centar Sestre milosrdnice
Clinic for Tumors Zagreb, Department of Medical Oncology, Ilica 197, 10000, Zagreb
Pula General Hospital Ospedale Generale di Pola
Department of Internal Oncology and Hematology, Santoriova Ulica 24a, Pula, Pula - Pola
ohO Research GmbH
Hämatologie/Onkologie der Sana Klinik Ostholstein, Muehlenkamp 5, 23758, Oldenburg In Holstein
Zentralklinik Bad Berka GmbH
Klinik für internistische Hämatologie, Onkologie und Privatmedizin, Robert-Koch-Allee 9, 99437, Bad Berka
Medical Center - University Of Freiburg
Klinik für Innere Medizin, Interdisziplinäres Tumorzentrum, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic & Research Unit - Oncology Unit, Rimini Street 1, 124 62, Athens
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Clinic of Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Theageneio Cancer Hospital
Pulmonary-Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
Molecular Medicine Clinic (4th Floor), Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
General University Hospital Of Patras
Division of Oncology - Department of Medicine, Rio, 265 04, Patras
General University Hospital Of Larissa
Medical Oncology Department, P. O. Box 1425, 411 10, Larissa
Ioannou Private Clinic-Private Polyclinics S.A.
Oncology & Chemotherapy Department, Vernardaki 13 Str, 383 33, Volos
General Oncological Hospital Of Kifissia Agioi Anargyroi
Medical Oncology Department, Timiou Stavrou And 14 Noufaron, 145 64, Kifissia
Azienda Sociosanitaria 3
SSD Oncologia, Via Agostino Bertani 4, 16125, Genoa
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Universitaria Senese
UOC Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unitá di Oncologia Toracica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Di Cremona
SC Oncology, Viale Concordia 1, 26100, Cremona
Fondazione IRCCS Policlinico San Matteo
UOC Oncologia 1, Viale Camillo Golgi 19, 27100, Pavia
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
San Camillo Forlanini Hospital
UOSD Pneumo-oncologia, Circonvallazione Gianicolense 87, 00152, Rome
Ospedale Vito Fazzi Lecce
U.O. Oncologia Medica, Piazza Filippo Muratore 1, 73100, Lecce
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Nie dotyczy, Ul. Polnocna 8/3, 20-064, Lublin
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddział Onkologii Klinicznej, Chemioterapii, Badan Klinicznych, Ul. Hubalczykow 1, 76-200, Slupsk
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddział Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
Instytut Msf Sp. z o.o.
Nie dotyczy, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Hospital Da Luz S.A.
Oncology, Avenida Lusiada 100, 1500-650, Lisbon
Hospital CUF Porto S.A.
Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Oncology, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Unidade Local De Saude De Matosinhos E.P.E.
Oncology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Onco Card S.R.L.
Oncologie Medicala, Strada Carierei 65 A, 500052, Brasov
Oncocenter Oncologie Clinica S.R.L.
Oncologie Medicala, Strada Garii 1a, 300166, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Sectia Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncolab S.R.L.
Oncologie Medicala, Strada Bujorului 7, 200385, Craiova
University Hospital Bratislava
Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Oddelenie klinickej onkológie, Ruzinovska 6, Ruzinov, Bratislava
Nemocnica Na Okraji Mesta N.O.
Not applicable, Nova Nemocnica 511, 958 01, Partizanske
Nsp Sv. Jakuba N.O. Bardejov
Not applicable, Sv. Jakuba 21, 085 01, Bardejov
Hospital Povisa S.A.
Oncology, Rua Salamanca 5, 36211, Vigo
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Consorci Sanitari Integral
Oncology, Avinguda De Josep Molins 29-41, 08906, L'hospitalet De Llobregat
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Moncloa Grupo Hla S.A.
Oncology, Avenida De Valladolid 83, 28008, Madrid
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
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 |
|---|---|---|---|---|---|
| Greece | 2025-10-13 | ||||
| Italy | 2025-11-26 | ||||
| Poland | 2025-09-30 | ||||
| Romania | 2025-10-06 | ||||
| Slovakia | 2025-09-05 | ||||
| Spain | 2025-10-21 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-20 | Poland | Acceptable with conditions 2025-03-24
|
2025-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-19 | Poland | Acceptable 2025-07-21
|
2025-07-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-03 | Acceptable | 2025-09-26 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-22 | Poland | Acceptable | 2025-10-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-24 | Poland | Acceptable | 2025-11-24 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-23 | Poland | Acceptable | 2026-01-23 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-30 | Poland | Acceptable 2026-05-04
|
2026-05-05 |