Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
720
Countries
3
Sites
23
Non-small-cell lung cancer
Key facts
- Sponsor
- H e x a l AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Aug 2024 → 16 Mar 2026
- Decision date (initial)
- 2024-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
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
H e x a l AG
- Sponsor organisation
- H e x a l AG
- Address
- Industriestrasse 25
- City
- Holzkirchen
- Postcode
- 83607
- Country
- Germany
Scientific contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Public contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Locations
3 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 41 | 5 |
| Romania | Ended | 31 | 9 |
| Spain | Ended | 17 | 9 |
| Rest of world
India, Turkey, Thailand, Philippines, United States, Serbia, Malaysia, Vietnam, Georgia, Brazil, Taiwan, Bosnia and Herzegovina
|
— | 631 | — |
Investigational sites
Fachkrankenhaus Coswig GmbH
1903: Pneumologie, Neucoswiger Strasse 21, 01640, Coswig
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
1900: Cardiology, Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden
Thoraxzentrum Bezirk Unterfranken
1905: Pneumology, Michelsberg 1, 97702, Muennerstadt
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis
1902: Allg. Innere Medizin, Biedermannstrasse 84, Connewitz, Leipzig
Romed Klinikum Rosenheim
1904: Med. Clinic III, Ellmaierstrasse 23, Ost, Rosenheim
Oncocenter Oncologie Clinica S.R.L.
3204:oncology, Strada Garii 1a, 300166, Timisoara
Oncolab S.R.L.
3206:Medical Oncology, Strada Bujorului 7, 200385, Craiova
Centrul De Oncologie SF Nectarie S.R.L.
3201:oncology, Strada Caracal Nr 109, 200542, Craiova
Medisprof S.R.L.
3202:oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Radiotherapy Center Cluj S.R.L.
3203:oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie-Euroclinic S.R.L.
3208:Oncology, Strada Conta Vasile 2, 700106, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
3200:Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncomed S.R.L.
3205:Medical Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Onco Clinic Consult S.A.
#3207:Oncology, Strada Sararilor 28j, 200508, Craiova
Hospital Arnau De Vilanova De Valencia
Oncología Médica, Calle De San Clemente 12, 46015, Valencia
Micancer Center S.L.P.
oncología médica, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital Quironsalud Malaga
oncología médica, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Clinico San Carlos
Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
MD Anderson Cancer Center
Oncología, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitari Vall D Hebron
oncología médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Reina Sofia
Oncología Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Central De Asturias
Oncología Médica, Avenida De Roma S/n, 33011, Oviedo
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Oncología Médica, Rua Doctor Camilo Veiras 1, 15009, A Coruna
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 |
|---|---|---|---|---|---|
| Germany | 2024-11-04 | 2024-11-04 | |||
| Romania | 2024-08-16 | 2024-08-16 | 2025-04-15 | ||
| Spain | 2024-09-17 | 2024-09-17 | 2025-04-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-80835
- Halt date
- 2025-04-15
- Member states concerned
- Romania
- Publication date
- 2025-04-30
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and growing indications that major Health Authorities (including the EMA) will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CGME751A12301 clinical study.
- Follow-up measures
- Sandoz will ensure that patients already treated in study CGME751A12301 will continue to receive treatment with pembrolizumab and chemotherapy as required per standard of care according to the Keytruda label.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80834
- Halt date
- 2025-04-15
- Member states concerned
- Spain
- Publication date
- 2025-04-30
- Reason
- Sponsor decision
- Explanation
- In light of the evolving regulatory landscape and growing indications that major Health Authorities (including the EMA) will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CGME751A12301 clinical study.
- Follow-up measures
- Sandoz will ensure that patients already treated in study CGME751A12301 will continue to receive treatment with pembrolizumab and chemotherapy as required per standard of care according to the Keytruda label.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Germany | Acceptable with conditions 2024-04-15
|
2024-04-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-03 | Germany | Acceptable with conditions 2024-04-15
|
2024-05-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-09 | Acceptable with conditions | 2024-07-15 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-09 | Germany | 2024-07-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-10 | Acceptable with conditions | 2024-05-30 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-14 | Germany | Acceptable with conditions | 2024-10-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-22 | Germany | Acceptable 2025-01-21
|
2025-01-21 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-04 | Acceptable | 2025-07-17 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-10 | Acceptable 2025-10-27
|
2025-11-03 |