Clinical trial • Phase III • Oncology

Pembrolizumab for Metastatic non-small cell lung cancer (PD-L1 TPS ≥50%)

Phase III trial of Pembrolizumab for Metastatic non-small cell lung cancer (PD-L1 TPS ≥50%).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic non-small cell lung cancer (PD-L1 TPS ≥50%)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
21-10-2024

Trial design

Randomised, open-label, comparator arm: keytruda (pembrolizumab) 25 mg/ml concentrate for solution for infusion, intravenous (comparator). test arm: mk-3475a (subcutaneous pembrolizumab coformulated with hyaluronidase). dose and schedule not specified in the provided data.-controlled Phase III trial in Poland, Germany, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arm: KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion, intravenous (Comparator). Test arm: MK-3475A (subcutaneous pembrolizumab coformulated with hyaluronidase). Dose and schedule not specified in the provided data.
Target Sample Size
52

Eligibility

Recruits 52 No vulnerable population selected (isVulnerablePopulationSelected: false). Subject information and informed consent forms are provided (documents: multiple L1_ICF and K1 recruitment/IC procedure documents for country-specific versions)..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Subject information and informed consent forms are provided (documents: multiple L1_ICF and K1 recruitment/IC procedure documents for country-specific versions).

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer(NSCLC)."}
  • {"criterion_text":"- Measurable disease as assessed by the local site investigator/radiology."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements."}
  • {"criterion_text":"- Received prior systemic anticancer therapy for their metastatic NSCLC."}
  • {"criterion_text":"- Known additional malignancy that is progressing or has required active treatment within the past 3 years."}
  • {"criterion_text":"- Known active CNS metastases and/or carcinomatous meningitis."}
  • {"criterion_text":"- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed."}
  • {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease."}
  • {"criterion_text":"- Active infection requiring systemic therapy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose","definition_or_measurement_approach":"AUC of pembrolizumab measured after the first dose (pharmacokinetic assessment as stated: \"To evaluate MK-3475A SC to pembrolizumab IV with respect to AUC\")."}
  • {"endpoint_text":"- Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State","definition_or_measurement_approach":"Ctrough of pembrolizumab measured at steady state (pharmacokinetic assessment as stated: \"To evaluate MK-3475A SC to pembrolizumab IV with respect to steady state Ctrough\")."}

Secondary endpoints

  • {"endpoint_text":"- Number of Participants Who Report ≥1 Adverse Event (AE)","definition_or_measurement_approach":"Count of participants reporting one or more adverse events."}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants discontinuing study intervention because of an adverse event."}

Recruitment

Planned Sample Size
52
Recruitment Window Months
19
Consent Approach
Informed consent obtained from participants. Subject information and informed consent form documents are available for participating countries in local languages (examples: Polish, German, Spanish, Romanian) and English versions indicated in document list. No assent process for minors is indicated.

Geography

Total Number Of Sites
14
Total Number Of Participants
51

Poland

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
32
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej,
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
BBK@szpital.siedlce.pl

Germany

Earliest CTIS Part Ii Submission Date
27-06-2025
Latest Decision Or Authorization Date
03-07-2025
Processing Time Days
6
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Klinik für Pneumologie, Schlaf -und Beatmungsmedzin
Contact Person Name
Wolf Brunner
Site Name
Universitaetsklinikum Jena KöR
Department Name
Hämatologie und intern. Onkologie
Contact Person Name
Jakob Hammersen

Spain

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
21-10-2024
Processing Time Days
11
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Noelia Vilariño Quintela
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Fundacion Onkologikoa Fundazioa
Department Name
Oncology
Contact Person Name
Ibone De Elejoste Echabarría
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
Teresa Garcia Manrique
Contact Person Email
tgarciamanrique.onco@gmail.com
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Oncology
Contact Person Name
Laura Fernandez Madrigal
Contact Person Email
laurafdez1992@hotmail.com

Romania

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
94
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Spitalul Municipal Ploiesti
Department Name
Oncologie Medicala
Contact Person Name
Pompilia Motatu
Contact Person Email
spitalschuller@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Andrei Ungureanu
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties codes: 4
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 4

Third parties

  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Home Health (PK Collection)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement and Rides share service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-3475A
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Investigational (no marketing authorisation indicated)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised (marketing authorisation EU/1/15/1024/002)
Combination Treatment
Yes

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