Clinical trial • Phase III • Oncology

Pembrolizumab for Metastatic non-squamous non-small cell lung cancer

Phase III trial of Pembrolizumab for Metastatic non-squamous non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic non-squamous non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
22-08-2024
First CTIS Authorization Date
12-12-2024

Trial design

Randomised, eu-approved keytruda (pembrolizumab) 200 mg iv every 3 weeks (q3w) in combination with platinum-pemetrexed chemotherapy (cisplatin or carboplatin), administered per protocol until unacceptable toxicity, disease progression, or a maximum of 18 cycles.-controlled Phase III trial across 30 sites in Croatia, Lithuania, Poland and others.

Randomised
Yes
Comparator
EU-approved Keytruda (pembrolizumab) 200 mg IV every 3 weeks (Q3W) in combination with platinum-pemetrexed chemotherapy (cisplatin or carboplatin), administered per protocol until unacceptable toxicity, disease progression, or a maximum of 18 cycles.
Target Sample Size
396
Trial Duration For Participant
378

Eligibility

Recruits 396 No vulnerable populations selected. Trial enrols adults (≥18 years). Informed consent is obtained from participants themselves; assent processes are not applicable..

Vulnerable Population
No vulnerable populations selected. Trial enrols adults (≥18 years). Informed consent is obtained from participants themselves; assent processes are not applicable.

Inclusion criteria

  • {"criterion_text":"- Male or female ≥ 18 years\n- Stage IV, non squamous NSCLC\n- Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines\n- Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization\n- Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)\n- Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan\n- Have a ECOG Performance score of ≤ 1, Life expectancy of at least 3 months\n- Have adequate organ function"}

Exclusion criteria

  • {"criterion_text":"- Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible\n- Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)\n- Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose\n- Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)\n- Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n- Is expected to require chronic systemic steroids\n- Have an active infection requiring systemic therapy (<2 weeks prior to the first dose)\n- Have interstitial lung disease or a history of pneumonitis that required steroids\n- Unable or unwilling to take folic acid or vitamin B12 supplementation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set","definition_or_measurement_approach":"Objective response rate (ORR: complete response [CR] + partial response [PR]) based on the confirmed best overall response (BOR) by the end of Cycle 11 according to RECIST v1.1 assessed in the intent-to-treat (ITT) population."}

Recruitment

Planned Sample Size
396
Recruitment Window Months
41
Consent Approach
Informed consent obtained from adult participants (participants must be ≥18 years). Subject information sheets and informed consent forms (ICFs) are provided; ICF documents available in multiple language versions as provided in the dossier (examples: English, Greek, Lithuanian, Romanian, Russian, Croatian, Polish, Spanish). Separate pregnancy/pregnant partner information and consent materials are included where applicable. Assent not applicable (no paediatric population).

Geography

Total Number Of Sites
30
Total Number Of Participants
210

Croatia

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
Pula General Hospital Ospedale Generale di Pola
Department Name
Department of Internal Oncology and Hematology
Contact Person Name
Dragan Trivanovic
Contact Person Email
Dragan.Trivanovic@obpula.hr
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Department of Oncology and Nuclear Medicine
Contact Person Name
Jasna Radic
Contact Person Email
jasnaradic@yahoo.com

Lithuania

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
17
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Department of Pulmonology
Contact Person Name
Marius Zemaitis
Site Name
Nacionalinis vezio institutas
Contact Person Name
Vaida Gedvilaite
Contact Person Email
vaida.gedvilaite@nvi.lt

Poland

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
28
Number Of Sites
10
Number Of Participants
60

Sites

Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddział Onkologiczny - Centrum Kompetencji Raka Piersi, Centrum Kompetencji Raka Jelita Grubego
Contact Person Name
Marcin Sokolowski
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Kliniczny Oddzial Pneumonologii, Alergologii, Onkologii Pulmonologicznej i Chorob Wewnetrznych
Contact Person Name
Janusz Milanowski
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
NA Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jaroslaw Kolb-Sielecki
Contact Person Email
j.kolbsielecki@gmail.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Magdalena Zaborowska- Szmit
Site Name
dr hab.n.med. Sławomir Mandziuk Specjalistyczna Praktyka Lekarska
Contact Person Name
Slawomir Mandziuk
Contact Person Email
Slawman7@wp.pl
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Contact Person Name
Anna Lowczak
Contact Person Email
onkoania@gazeta.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Contact Person Name
Agata Kachel-Flis
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Beata Freier
Contact Person Email
beatafreier.bf@gmail.com
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl

Romania

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
22-04-2025
Processing Time Days
225
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Oncolab S.R.L.
Department Name
Specialitatea Oncologie Medicala
Contact Person Name
Dan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Specialitatea Oncologie Medicala
Contact Person Name
Daniela Elvira Sirbu
Contact Person Email
desirbu@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie
Contact Person Name
Carmen Elena Floares
Contact Person Email
carmen_ganea@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Generala si Chimioterapie
Contact Person Name
Cristina Ligia Cebotaru
Contact Person Email
cristinacebotaru@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
203
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Departments of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
Ksyrigos.trials@gmail.com
Site Name
Theageneio Cancer Hospital
Department Name
3rd Department of Clinical Oncology
Contact Person Name
Anastasios Boutis
Contact Person Email
alboutis@otenet.gr
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
7th Oncology Clinic
Contact Person Name
Panagiotis Katsaounis
Contact Person Email
pvkatsaounis@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
129
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Jesus Corral Jaime
Contact Person Email
jesuscorraljaime@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Johana Cristina Benedetti Pedroza
Contact Person Email
benedettipedroza@gmail.com
Site Name
Hospital Universitario De Torrejon
Department Name
Oncology
Contact Person Name
Luis Cabezon Gutierrez
Contact Person Email
lcabezon@torrejonsalud.com
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
José Luis González Larriba
Contact Person Email
jglarriba@salud.madrid.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Gema María García Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Andres Barba Joaquin
Contact Person Email
abarba@santpau.cat
Site Name
Hospital Quironsalud Malaga
Department Name
Oncology
Contact Person Name
Manuel Angel Cobo Dols
Contact Person Email
lcabezon@torrejonsalud.com
Site Name
Hospital La Milagrosa S.A.
Department Name
Oncology
Contact Person Name
Lisardo Ugidos de la Varga
Contact Person Email
lisardo.ugidos@vithas.es

Sponsor

Primary sponsor

Full Name
Celltrion Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Korea, Republic of

Contract research organisations

Name
Syneos Health Romania S.R.L.
Responsibilities
Romania CRO responsible for all clinical trial-related duties (e.g. study startup, monitoring, regulatory, etc)
Name
Syneos Health Hellas Single Member S.A.
Responsibilities
Greece CRO responsible for all clinical trial-related duties (e.g. study startup, monitoring, regulatory, etc)

Third parties

  • {"country":"Romania","full_name":"Syneos Health Romania S.R.L.","duties_or_roles":"Romania CRO responsible for all clinical trial-related duties (e.g. study startup, monitoring, regulatory, etc)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"Greece CRO responsible for all clinical trial-related duties (e.g. study startup, monitoring, regulatory, etc)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Pembrolizumab (CT-P51)
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Investigational product (CT-P51, sponsor product) - prodAuthStatus indicates investigational (prodAuthStatus=1)
Starting Dose
200 mg
Dose Levels
200 mg (per protocol dosing described as 200 mg IV)
Frequency
Q3W (every 3 weeks)
Maximum Dose
200 mg per dose; product record max total dose amount 7000 mg
Investigational Product Name
KEYTRUDA (pembrolizumab)
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Marketing authorisation (EU-approved Keytruda, prodAuthStatus=2)
Starting Dose
200 mg
Dose Levels
200 mg (per protocol dosing described as 200 mg IV)
Frequency
Q3W (every 3 weeks)
Maximum Dose
200 mg per dose; product record max total dose amount 3600 mg
Investigational Product Name
Pemetrexed (Pemetrexed Fresenius Kabi / ALIMTA)
Active Substance
Pemetrexed
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation (authorised products listed, prodAuthStatus=2)
Starting Dose
500 mg/m2 (product maxDailyDoseAmount reported as 500 mg/m2)
Dose Levels
500 mg/m2 (as per product information)
Frequency
Q3W (every 3 weeks, given in combination per protocol)
Maximum Dose
Product record max total dose amount 17500 mg (cumulative)
Investigational Product Name
Cisplatin (Cisplatin Hikma)
Active Substance
Cisplatin
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation (prodAuthStatus=2)
Starting Dose
75 mg/m2 (product maxDailyDoseAmount reported as 75 mg/m2)
Dose Levels
75 mg/m2
Frequency
Q3W (every 3 weeks, per protocol combination regimen)
Maximum Dose
Product record max total dose amount 300 mg
Investigational Product Name
Carboplatin (Carboplatin Hikma)
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Marketing authorisation (prodAuthStatus=2)
Starting Dose
Dose reported as mg (product maxDailyDoseAmount 750 mg); protocol uses carboplatin per investigator choice (no explicit mg in JSON)
Dose Levels
per product/clinical practice (product maxDailyDoseAmount 750 mg reported)
Frequency
Q3W (every 3 weeks, per protocol combination regimen)
Maximum Dose
Product record max total dose amount 3000 mg
Combination Treatment
Yes

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