Clinical trial • Phase III • Oncology
pembrolizumab for Non-small cell lung cancer
Phase III trial of pembrolizumab for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 22-09-2023
- First CTIS Authorization Date
- 16-01-2024
Trial design
Randomised, keytruda (pembrolizumab) 25 mg/ml concentrate for solution for infusion (comparator product listed; product record indicates maxdailydoseamount 200 mg but trial dosing/schedule not specified)-controlled Phase III trial in Spain, Romania, Germany.
- Randomised
- Yes
- Comparator
- KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion (comparator product listed; product record indicates maxDailyDoseAmount 200 mg but trial dosing/schedule not specified)
- Target Sample Size
- 459
- Trial Duration For Participant
- 1260
Eligibility
Recruits 459 Vulnerable population selected (isVulnerablePopulationSelected: true). Specific consent or assent handling is not detailed in the CTIS record; subject information and informed consent forms are provided (Main ICF documents available in country-specific versions)..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Specific consent or assent handling is not detailed in the CTIS record; subject information and informed consent forms are provided (Main ICF documents available in country-specific versions).
Inclusion criteria
- {"criterion_text":"- Male or female ≥ 18 years of age\n- Have been diagnosed with stage IV non-squamous NSCLC\n- Have not received any prior systemic anti-cancer therapy for metastatic NSCLC\n- Agree to use adequate methods of contraception"}
Exclusion criteria
- {"criterion_text":"- Unable to take folic acid and vitamin B12 supplementation\n- Unable to receive chemotherapy during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- objective response rate (ORR)","definition_or_measurement_approach":"Not specified in the CTIS data"}
Recruitment
- Planned Sample Size
- 459
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent required from participants (inclusion criteria specify age ≥ 18). Main informed consent forms (L1 Main ICF) are provided and available in country-specific versions (Spanish, Romanian, German); additional related ICF documents (e.g. Pregnant Partner ICF) are present. Specific assent processes or proxy consent procedures are not detailed in the CTIS record.
Methods
- Physician Referral Letter (document titles: Physician Referral Letter) - channel: referral by treating physicians; country-specific versions provided (Spain/RO/DE).
- Recruitment Poster (document titles: Recruitment Poster) - channel: public posters; country-specific versions provided (Spain/RO/DE).
- Subject Brochure (document titles: Subject Brochure) - channel: informational brochure for potential participants; country-specific versions provided (Spain/RO/DE).
- Recruitment and ICF process documents (document titles: Recruitment and ICF process) - describes recruitment and informed consent procedures; country-specific documents available (Spain/RO/DE).
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 96
Spain
- Earliest CTIS Part Ii Submission Date
- 03-11-2023
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 873
- Number Of Sites
- 7
- Number Of Participants
- 42
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Contact Person Name
- Luis Angel Leon Mateos
- Contact Person Email
- Luis.Angel.Leon.Mateos@sergas.es
- Site Name
- Hospital Universitario Severo Ochoa
- Department Name
- Oncology
- Contact Person Name
- Ana Lopez Martin
- Contact Person Email
- almartin@salud.madrid.org
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Contact Person Name
- Emilio Esteban Gonzalez
- Contact Person Email
- eestebang@seom.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Francisco de Asis Aparisi Aparisi
- Contact Person Email
- francisco_aparisi@iislafe.es
- Site Name
- Complejo Hospitalario Universitario De Ourense
- Department Name
- Oncology
- Contact Person Name
- Maria Carmen Areses Manrique
- Contact Person Email
- Maria.Carmen.Areses.Manrique@sergas.es
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuel.cobo.co@quironsalud.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Reyes Bernabe Caro
- Contact Person Email
- bernabeensayos@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 836
- Number Of Sites
- 8
- Number Of Participants
- 43
Sites
- Site Name
- Oncolab S.R.L.
- Contact Person Name
- Dan Lungulescu
- Contact Person Email
- dan.lungulescu@yahoo.com
- Site Name
- Pelican Impex S.R.L.
- Department Name
- Oncologie
- Contact Person Name
- Ioana-Adriana Ciurescu
- Contact Person Email
- ioana_covaciu@yahoo.com
- Site Name
- Medisprof S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Adrian Udrea
- Contact Person Email
- adrianudrea@medisprof.ro
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Sibiu
- Contact Person Name
- Monica Patran
- Contact Person Email
- mpatran@yahoo.com
- Site Name
- Sigmedical Services S.R.L.
- Contact Person Name
- Doina Elena Ganea
- Contact Person Email
- motan_doina@yahoo.com
- Site Name
- Onco Clinic Consult S.A.
- Contact Person Name
- Patricia Visan
- Contact Person Email
- p.visan@oncoclinic.ro
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- cvolovat@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 28-12-2023
- Latest Decision Or Authorization Date
- 26-03-2026
- Processing Time Days
- 819
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Kaiserswerther Diakonie
- Department Name
- Klinik für Pneumologie, Kardiologie und internistische Intensivmedizin
- Contact Person Name
- Gunther Vogel
- Contact Person Email
- vogelg@kaiserswerther-diakonie.de
- Site Name
- MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
- Department Name
- -
- Contact Person Name
- Lars Galonska
- Contact Person Email
- galonska@onko-neuss.de
- Site Name
- Martha-Maria Krankenhaus Halle-Doelau gGmbH
- Department Name
- Clinic for internal medicine II
- Contact Person Name
- Wolfgang Schuette
- Contact Person Email
- wolfgang.schuette@martha-maria.de
- Site Name
- Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
- Department Name
- Medizinische Klinik III, Pneumologie
- Contact Person Name
- Karl-Otto Kambartel
- Contact Person Email
- kambartel@bethanienmoers.de
Sponsor
Primary sponsor
- Full Name
- Samsung Bioepis Co. Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- CRO
Third parties
- {"country":"Singapore","full_name":"IQVIA RDS East Asia Pte Ltd","duties_or_roles":"code:8","organisation_type":"Industry"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CluePoints SA","duties_or_roles":"Risk-Based Quality Management system provider","organisation_type":"Health care"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Reading Center","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central laboratory (PK/IMM sample shipment, PK/IMM sample management, kit shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
- {"country":"Korea, Democratic People's Republic of","full_name":"Veeva Systems Korea YH.","duties_or_roles":"code:7","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- SB27 (proposed pembrolizumab biosimilar)
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Maximum Dose
- 200 mg (maxDailyDoseAmount 200)
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Authorisation Status
- Marketing authorisation present for reference product (marketingAuthNumber: EU/1/15/1024/002)
- Maximum Dose
- 200 mg (maxDailyDoseAmount 200)
- Investigational Product Name
- PEMETREXED
- Active Substance
- pemetrexed
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Maximum Dose
- 500 mg/m2 (maxDailyDoseAmount 500 mg/m2)
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- carboplatin
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Maximum Dose
- 750 mg (maxDailyDoseAmount 750)
- Combination Treatment
- Yes
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