Study of V940 and Pembrolizumab for Patients with Resected Stage II, IIIA, IIIB Non-Small Cell Lung Cancer

3 1 1

What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-small Cell Lung Cancer (NSCLC), specifically in stages II, IIIA, and IIIB. The study is investigating the effects of a treatment combination involving two medications: V940 (mRNA-4157) and Pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is a medication that helps the immune system fight cancer cells, while mRNA-4157 is a new type of treatment that uses a small piece of genetic material to help the body recognize and attack cancer cells.

The purpose of the study is to compare the effectiveness of the combination of V940 and Pembrolizumab against a combination of a placebo and Pembrolizumab. Participants in the study will have already undergone surgery to remove their lung cancer and will receive additional treatment to help prevent the cancer from returning. The study will involve regular visits to the clinic for treatment and monitoring over a period of time. Participants will receive either the active treatment or a placebo, which is a substance with no active medication, along with Pembrolizumab.

The study aims to understand how well the treatment works in preventing the return of cancer and improving survival rates. It will also monitor the overall health and quality of life of participants during the study. The trial will help determine if the new treatment combination is more effective than the current standard treatment in keeping the cancer from coming back and improving the lives of those affected by this type of lung cancer.

1 joining the study

Participation begins after confirmation of eligibility, which includes having undergone surgery for non-small cell lung cancer (NSCLC) and meeting specific health criteria.

Eligibility is confirmed based on the absence of disease and completion of prior chemotherapy.

2 initial treatment phase

The treatment involves receiving pembrolizumab and either mRNA-4157 or a placebo.

Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein.

mRNA-4157 or placebo is given as an intramuscular injection, which means it is injected into a muscle.

3 treatment schedule

The specific dosage and frequency of the medications are determined by the study protocol and will be explained during the treatment phase.

The duration of the treatment phase is aligned with the study’s objectives and will be communicated during participation.

4 monitoring and follow-up

Regular monitoring is conducted to assess health status and response to treatment.

Follow-up includes evaluations of disease-free survival and overall health, using questionnaires and medical assessments.

5 completion of the study

The study is estimated to conclude by December 21, 2035.

Final assessments will be conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have had a type of lung cancer called non-small cell lung cancer that was completely removed by surgery. The cancer should be at Stage II, IIIA, or IIIB with certain lymph node involvement, according to specific guidelines.
  • The patient must show no evidence of disease before being assigned to a treatment group in the study.
  • The patient must have received at least one dose of a follow-up treatment called platinum doublet chemotherapy, which is a standard treatment after surgery.
  • No more than 24 weeks should have passed between the surgery and the first dose of a medication called pembrolizumab.
  • If the patient has a history of hepatitis B, they can participate if they have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the patient has a history of hepatitis C, they can participate if there is no detectable virus in their blood at the time of screening.
  • If the patient is infected with HIV, they must have the virus well controlled with medication.
  • Both male and female patients can participate in the study.

Who Cannot Join the Study?

  • Patients with a different type of lung cancer than Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
CHU Gabriel-Montpied Clermont Ferrand France
Asklepios Klinik Gauting GmbH Gauting Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Helse Stavanger HF Stavanger Norway
University Hospital Bratislava Bratislava Slovakia
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Vitaz Sint-Niklaas Belgium
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Oulu University Hospital Oulu Finland
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Henry Dunant Hospital Center Athens Greece
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Hospital Quironsalud Malaga Malaga Spain
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Vaasa Central Hospital Vaasa Finland
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Odense University Hospital Odense Denmark
Vestre Viken HF Drammen Norway
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Tartu University Hospital Tartu Estonia
Turku University Hospital Turku Finland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH Paderborn Germany
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Rigshospitalet Copenhagen Denmark
University Of Pecs Pecs Hungary
Pirkanmaan hyvinvointialue Tampere Finland
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Caen Normandie Caen France
North Estonia Medical Centre Foundation Tallin Estonia
AZORG Aalst Belgium
Vdsfpkpnh istbqlif Vpeteqch ugdedxhomnhb llqalawqv Sbbnllen kyoxpjg flxfgzms Nyuvwkfrnwpn vnsms cyokkws Vilnius Lithuania
Iqqttuxb Cumlfg Dbmiqpbrmmkoasyre L'hospitalet De Llobregat Spain
Akseczkcpqyutseargakvme gkhql Bochum Germany
Ndadpwgei Bbre aluj Bratislava Slovakia
Bsohcxyxrqq Vgxdglwgh Ohzuibyynini Kecskemet Hungary
Ljcwg Gnumorx Hirpfnnz Ol Atxkwq Athens Greece
Aehydawfcy Psjfufiq Hntmrhjp Dj Mfaiiyuuf Marseille France
Aykpdsqt Ulyzkoqrzi Hcbgzpju Lorenskog Norway
Rjvzv Apuwwdmx kszewqrr uyivquddzknzj svonoads Sal Riga Latvia
Ggsephpyojhpotpnu Vehheqzda Pbhq Adaxrx Eikcqpyj Oofrwx Katnwl Gyor Hungary
Atvokp Mkfdiaq Cgjcma Soco Thessaloniki Greece
Nwjdtefc Iuezhvvr Ocbixbjia Iyy Mfrra Savjougifltolawvqlhaftyyhdmg Ifslifwr Bzuozngq Cracow Poland
Ufpdahpjitmtmp Ckzpoqp Kmxtjsitl Gdansk Poland
Ubreytgkuk Ob Aloesby Edegem Belgium
Hxfcjgyn Vods deupcogc Barcelona Spain
Wyfdlvxljw Susbpkv Ibk Sahcovt Pli W Pdjfooxty Przemysl Poland
Ktijqlyfk Sgtvhnl Sysycopskfzdagg im Jknd Prakz Is Cracow Poland
Hqyhhysz Uxholbuzmhvkvv Stmbielflh &vrmmve Hphcoja dz Hdchyrmndas STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
05.04.2024
Czechia Czechia
Not recruiting
05.04.2024
Denmark Denmark
Not recruiting
05.04.2024
Estonia Estonia
Recruiting
05.04.2024
Finland Finland
Not recruiting
05.04.2024
France France
Recruiting
05.04.2024
Germany Germany
Recruiting
05.04.2024
Greece Greece
Recruiting
05.04.2024
Hungary Hungary
Recruiting
05.04.2024
Ireland Ireland
Recruiting
05.04.2024
Italy Italy
Recruiting
05.04.2024
Latvia Latvia
Recruiting
05.04.2024
Lithuania Lithuania
Not recruiting
05.04.2024
Norway Norway
Not recruiting
05.04.2024
Poland Poland
Recruiting
05.04.2024
Portugal Portugal
Not recruiting
05.04.2024
Slovakia Slovakia
Not recruiting
05.04.2024
Spain Spain
Recruiting
05.04.2024

Trial locations

Investigated drugs:

V940 (mRNA-4157) is an investigational medication being studied for its potential to help the immune system recognize and fight cancer cells. It is designed to work by using messenger RNA (mRNA) technology to instruct the body to produce proteins that can trigger an immune response against cancer.

Pembrolizumab is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific protein on the surface of immune cells, which allows these cells to better identify and attack cancer cells. Pembrolizumab is used in various types of cancer treatments and is being studied in combination with V940 to see if it improves outcomes for patients with certain types of lung cancer.

Investigated diseases:

Non-small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In stages II, IIIA, and IIIB (N2), the cancer has spread to nearby lymph nodes or other parts of the lung but not to distant organs. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms.

Trial ID:
2023-504923-20-00
Protocol code:
V940-002
Trial Phase:
Therapeutic confirmatory (Phase III)

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