Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
555
Countries
3
Sites
19
Non-small Cell Lung Cancer
"To demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC)"
Key facts
- Sponsor
- Samsung Bioepis Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Feb 2024 → ongoing
- Decision date (initial)
- 2024-01-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
"To demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC)"
Conditions and MedDRA coding
Non-small Cell Lung Cancer
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female ≥ 18 years of age
- Have been diagnosed with stage IV non-squamous NSCLC
- Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
- Agree to use adequate methods of contraception
Exclusion criteria 2
- Unable to take folic acid and vitamin B12 supplementation
- Unable to receive chemotherapy during the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- objective response rate (ORR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10684646 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 6600 mg milligram(s)
- Max treatment duration
- 100 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- SAMSUNG BIOEPIS CO., LTD.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 6600 mg milligram(s)
- Max treatment duration
- 100 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081132 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 6600 mg milligram(s)
- Max treatment duration
- 100 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 16500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Samsung Bioepis Co. Ltd.
- Sponsor organisation
- Samsung Bioepis Co. Ltd.
- Address
- 76 Songdogyoyuk Ro
- City
- Yeonsu
- Postcode
- 21987
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Public contact point
- Organisation
- Samsung Bioepis Co. Ltd.
- Contact name
- Regulatory affairs
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA RDS East Asia Pte Ltd ORL-000002832
|
Singapore, Singapore | Code 8 |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| CluePoints SA ORL-000002830
|
Louvain-La-Neuve, Belgium | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Other |
| Veeva Systems Korea YH. ORL-000002831
|
Seoul, Korea, Democratic People's Republic of | E-data capture |
Locations
3 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 11 | 4 |
| Romania | Ongoing, recruitment ended | 43 | 8 |
| Spain | Ongoing, recruitment ended | 42 | 7 |
| Rest of world
Turkey, Philippines, Bosnia and Herzegovina, Japan, Malaysia, Brazil, Serbia, India, Thailand, Mexico, Georgia
|
— | 459 | — |
Investigational sites
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Clinic for internal medicine II, Roentgenstrasse 1, Doelau, Halle (saale)
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
-, Am Hasenberg 44, Furth-Mitte, Neuss
Kaiserswerther Diakonie
Klinik für Pneumologie, Kardiologie und internistische Intensivmedizin, Kreuzbergstrasse 79, Kaiserswerth, Duesseldorf
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Medizinische Klinik III, Pneumologie, Bethanienstrasse 21, Innenstadt, Moers
Oncolab S.R.L.
Oncology, Strada Bujorului 7, 200385, Craiova
Sigmedical Services S.R.L.
Oncologie, Bis The Building Corp A, Strada Zamca Nr 21 Et 3, Suceava
Pelican Impex S.R.L.
Oncologie, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Onco Clinic Consult S.A.
Oncologie, Strada Sararilor 28j, 200508, Craiova
Centrul De Oncologie-Euroclinic S.R.L.
Oncologie, Strada Conta Vasile 2, 700106, Iasi
Spitalul Clinic Judetean De Urgenta Sibiu
Oncology, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Severo Ochoa
Oncology, Avenida Orellana S/n, 28911, Leganes
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 | 2024-04-24 | 2024-04-25 | 2025-09-30 | ||
| Romania | 2024-02-16 | 2024-03-28 | 2025-09-30 | ||
| Spain | 2024-03-14 | 2024-05-16 | 2025-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_SB27-3004_Protocol_Redacted | 4.0 |
| Protocol (for publication) | D1_SB27-3004_Risk and Benefit Assessment_Signed_Redacted_Completed | 1.0 |
| Recruitment arrangements (for publication) | K1_SB27-3004_DE_Recruitment and ICF process | NA |
| Recruitment arrangements (for publication) | K1_SB27-3004_ES_Recruitment and Informed consent procedure Form | NA |
| Recruitment arrangements (for publication) | K1_SB27-3004_RO_Recruitment and ICF process | NA |
| Recruitment arrangements (for publication) | K2_SB27-3004_DE_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_DE_Recruitment Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_DE_Subject Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_ES_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_ES_Recruitment Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_ES_Subject Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_RO_Physician Referral Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_RO_Recruitment Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_SB27-3004_RO_Subject Brochure | 1.0 |
| Subject information and informed consent form (for publication) | L1_SB27-3004_DE_Main ICF_German_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SB27-3004_DE_Pregnant Partner ICF_German_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SB27-3004_ES_Main ICF | 7.0 |
| Subject information and informed consent form (for publication) | L1_SB27-3004_RO_Main ICF_Romania_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SB27-3004_RO_PP ICF_Romania | 2.0 |
| Subject information and informed consent form (for publication) | L2_SB027-3004_DE_request for review acc to StrSchG | 1 |
| Subject information and informed consent form (for publication) | L2_SB27-3004_ES_Annex I to Main ICF _Protection of Personal Data | 7.0 |
| Subject information and informed consent form (for publication) | L3_SB27-3004_ES_Annex II to Main ICF_Study Visits and Procedures | 7.0 |
| Subject information and informed consent form (for publication) | L4_SB27-3004_ES_Pregnant Partner ICF | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Keytruda_EU | NA |
| Synopsis of the protocol (for publication) | D1_SB27-3004_ES_Layperson Protocol Synopsis_Spanish | 1.0 |
| Synopsis of the protocol (for publication) | D1_SB27-3004_ES_Protocol synopsis_Spanish | 4.0 |
| Synopsis of the protocol (for publication) | D1_SB27-3004_Layperson Summary of Protocol Synopsis_EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_SB27-3004_RO_Layperson Summary of Protocol Synopsis_Romanian | 1.0 |
| Synopsis of the protocol (for publication) | D1_SB27-3004_RO_Protocol synopsis_Romanian | 4.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-22 | Spain | Acceptable 2024-01-16
|
2024-01-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-06 | Acceptable | 2024-03-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-08 | Acceptable | 2024-04-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-09 | Spain | Acceptable | 2024-02-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-11 | Acceptable | 2024-04-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-10 | Spain | Acceptable 2024-06-18
|
2024-06-18 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-19 | Spain | Acceptable 2024-11-21
|
2024-11-21 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-31 | Spain | Acceptable 2024-11-21
|
2025-01-31 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-27 | Spain | Acceptable 2025-05-05
|
2025-05-05 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-12 | Spain | Acceptable 2025-07-28
|
2025-07-31 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-01 | Acceptable | 2025-10-22 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-02-10 | Spain | Acceptable 2026-03-24
|
2026-03-25 |