Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,666
Countries
3
Sites
49
Maintenance treatment in metastatic non-squamous lung cancer
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 20 Mar 2023 → ongoing
- Decision date (initial)
- 2025-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503481-23-00
- EudraCT number
- 2021-006795-16
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Maintenance treatment in metastatic non-squamous lung cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Gustave Roussy
- Sponsor organisation
- Institut Gustave Roussy
- Address
- 114 Rue Edouard Vaillant
- City
- Villejuif
- Postcode
- 94800
- Country
- France
Scientific contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Pr. Benjamin BESSE
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Pr. Benjamin BESSE
Locations
3 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 200 | 12 |
| France | Ongoing, recruiting | 1,166 | 31 |
| Spain | Ongoing, recruiting | 300 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
Onze-Lieve-Vrouwziekenhuis
Pneumology, Moorselbaan 164, 9300, Aalst
Jessa Ziekenhuis
Pneumology, Stadsomvaart 11, 3500, Hasselt
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncology, Place Louise Godin 15, 5000, Namur
Centre Hospitalier Regional De La Citadelle
Pneumology, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Grand Hopital De Charleroi
Oncology & Hematology, Grand'rue 3, 6000, Charleroi
CHU Helora
Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
CHU De Charleroi Hopital Andre Vesale
Oncology, Rue De Gozee 706, 6110, Montigny-Le-Tilleul
Institut Jules Bordet
Thoracic Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pneumology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Institut Gustave Roussy
Département d'oncologie médicale. Malignités thoraciques, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier De La Cote Basque
Oncologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
University Hospitals Pitie Salpetriere Charles Foix
oncologie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Intercommunal Creteil
ONCOLOGIE, 40 Avenue De Verdun, 94000, Creteil
Hopital Tenon
oncologie, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Hospitalier Intercommunal Compiegne Noyon
oncologie, 8 Avenue Henri Adnot, 60200, Compiegne
Centre Hospitalier de Saint-Malo
ONCOLOGIE, 1 Rue de la Marne, France, Saint-Malo
Hôpital d'Instruction des Armées Bégin
ONCOLOGIE, 69 Av. de Paris, 94160, Saint-Mandé
Hôpital Cochin
ONCOLOGIE, 27 rue du Fbg St Jacques, 75014, Paris
Centre Hospitalier Universitaire - La Réunion - Site Sud
ONCOLOGIE, Avenue François Mitterrand BP 350 97448, 974, Saint-Pierre - La Reunion
Centre Hospitalier Universitaire - La Réunion - Site Felix Guyon
ONCOLOGIE, Allée des topazes CS 11 021, 97400, Sain-Denis-Réunion
Centre Hospitalier De Carcassonne
ONCOLOGIE, 1060 Chemin De La Madeleine, 11000, Carcassonne
Centre Hospitalier Régional Universitaire de Tours
oNCOLOGIE, 2 Boulvard Tonnelé, 37000, Tours
Centre Hospitalier Régional d'Orléans - NHO
ONCOLOGIE, 4 Av. de l'Hôpital,, 45100, Orléans
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
ONCOLOGIE, 87, avenue d'altkirch, Mulhouse
Hospices Civils de Lyon - Hôpital Louis Pradel
ONCOLOGIE, 59 Bd Pinel,, 69500, Bron
Hospital Foch
ONCOLOGIE, 40 Rue Worth, 92150, Suresnes
Hopital Jean Minjoz
ONCOLOGIE, 3 boulevard Jean Minjoz, 25030, Besançon
Hopital Europeen Marseille
ONCOLOGIE, 6 Rue Desiree Clary, 13003, Marseille
Institut De Cancerologie Strasbourg Europe
ONCOLOGIE, 17 Rue Albert Calmette, 67200, Strasbourg
Clinique Sainte Anne
ONCOLOGIE, Rue Philippe Thys, 67000, Strasbourg
Centre Hospitalier Universitaire De Saint Etienne
ONCOLOGIE, 25 Boulevard Pasteur, 42100, Saint-Etienne
Hôpital Paris Saint-Joseph
ONCOLOGIE, 185 Rue Raymond Losserand, 75014, Paris
Centre Hospitalier D Auxerre
ONCOLOGIE, 2 Boulevard De Verdun, 89000, Auxerre
Centre Hospitalier De Cholet
ONCOLOGIE, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier De Beziers
ONCOLOGIE, Zone Dactivite Montimaran, 2 Rue Valentin Hauy, Beziers
Centre Hospitalier Pays de Morlaix
ONCOLOGIE, 15 Rue de Kersaint Gilly, 29600, Morlaix
Centre Hospitalier Tarbes-Lourdes
ONCOLOGIE, Bd Du Mal De Lattre De Tassigny, Bp 1330, Tarbes Cedex 9
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
ONCOLOGIE, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Universitaire De Rennes
ONCOLOGIE, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Regional Et Universitaire De Brest
ONCOLOGIE, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
Hospital Clinico San Carlos
MEDICAL ONCOLOGY, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De La Santa Creu I Sant Pau
oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Virgen de la Victoria
oncology, Hospital Universitario Virgen de la Victoria, Urologia. Campus de Teatinos, Malaga
Hospital Universitario 12 De Octubre
oncology, Avenida De Cordoba Sn, 28041, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-05-02 | 2025-07-01 | |||
| France | 2023-03-20 | 2023-03-20 | |||
| Spain | 2025-02-28 | 2025-05-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | France | Acceptable 2024-03-07
|
2024-03-12 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-11-01 | 2024-12-23 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-12-05 | Acceptable 2024-03-07
|
2025-02-27 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-06 | Acceptable 2024-03-07
|
2025-03-06 |