Study of Pembrolizumab and V940 for Treating Non-Small Cell Lung Cancer in Patients with Resectable Stage II to IIIB (N2) Not Achieving Complete Response

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What is this study about?

This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will explore the effectiveness of a combination of treatments, including pembrolizumab (also known as Keytruda) and a new investigational treatment called mRNA-4157. Pembrolizumab is a medication that helps the immune system fight cancer, while mRNA-4157 is a new type of treatment being tested for its potential to improve outcomes in cancer therapy. The study will also involve a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to compare the effects of the combination of mRNA-4157 and pembrolizumab with pembrolizumab alone in patients with resectable Stage II to IIIB NSCLC who have not achieved a complete response after initial treatment. Participants will receive these treatments through intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 42 weeks, during which participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, researchers will assess various outcomes, including how long patients remain free of cancer, overall survival rates, and the quality of life of participants. The study aims to provide valuable information on whether the addition of mRNA-4157 to pembrolizumab can offer better results for patients with NSCLC. This research is part of ongoing efforts to find more effective treatments for lung cancer and improve the lives of those affected by this disease.

1 joining the study

Upon joining the study, the participant will be assessed to confirm eligibility based on specific criteria, including a confirmed diagnosis of non-small cell lung cancer (NSCLC) and other health conditions.

2 initial treatment phase

Participants will receive neoadjuvant treatment, which includes chemotherapy with platinum-based drugs and pembrolizumab, a medication administered through an intravenous infusion. This phase is completed before surgery.

3 surgery

After the initial treatment phase, participants will undergo surgery to remove the tumor. The success of the surgery will be evaluated to determine the next steps in the study.

4 adjuvant treatment phase

Participants who do not achieve a complete response from the initial treatment will enter the adjuvant treatment phase. This involves receiving pembrolizumab and either V940 or a placebo. Pembrolizumab is given as an intravenous infusion, while V940 is administered intramuscularly.

5 monitoring and follow-up

Throughout the study, participants will be monitored for disease-free survival and overall health. Regular assessments will be conducted to track the effectiveness of the treatment and any side effects experienced.

6 completion of the study

The study is expected to continue until 2038. Participants will be followed up regularly to assess long-term outcomes, including overall survival and quality of life.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is at Stage II, IIIA, or IIIB (N2) and can be surgically removed.
  • The patient should have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient is eligible if they did not achieve a complete response to initial chemotherapy and pembrolizumab treatment before surgery.
  • The patient must not need a specific treatment for a type of mutation in the cancer called EGFR mutation.
  • If the patient has HIV, it must be well controlled with medication.
  • If the patient has hepatitis B, they must have been treated 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, the virus must not be detectable in their blood at the time of screening.
  • The study is open to both male and female patients.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer cannot participate. Non-Small Cell Lung Cancer is a type of lung cancer that grows and spreads more slowly than other types.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Koranyi National Institute For Pulmonology Budapest Hungary
Frisius Heerenveen The Netherlands
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Sigmedical Services S.R.L. Suceava Romania
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universitair Ziekenhuis Gent Gent Belgium
Isala Klinieken Stichting Zwolle The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Medicover S.R.L. Bucharest Romania
University General Hospital Of Heraklion Heraklion Greece
Oulu University Hospital Oulu Finland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Henry Dunant Hospital Center Athens Greece
Marienhaus Klinikum Mainz GmbH Mainz Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Hospital Quironsalud Malaga Malaga Spain
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Matrai Gyogyintezet Gyongyos Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Institutul Regional De Oncologie Iasi Iasi Romania
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Meander Medical Center Amersfoort The Netherlands
Turku University Hospital Turku Finland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Jessa Ziekenhuis Hasselt Belgium
Oncomed S.R.L. Timisoara Romania
General University Hospital Of Patras Patras Greece
Justus-Liebig-Universitaet Giessen Giessen Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Caen Normandie Caen France
Metropolitan Hospital Athens Greece
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Instytut Gruźlicy i Chorób Płuc Warsaw Poland
Coqzmensm Uxyjzmxzepgafh Smzjhvjog Woluwe-Saint-Lambert Belgium
Cmqliw Lash Bbjzxh Lyon France
Ivaepk Iugxscse Fyqaawcltkyhm Ozuywlmwqpr Rome Italy
Usasbttlzogm Mrsntaq Cjcrjmu Gwmuiegce Groningen The Netherlands
Cobd Ukehdebyrg Hhqtntuy Cork Ireland
Dqczyfmsueju Cmqarbj Obqymizsm Pnkxalfmotjx I Hkpphqudxym Wroclaw Poland
Shipcwkymqdjcugvyqtwp gtfyo Eschweiler Germany
Niwwel Vhwwrdyfg Snuxe Llmul Kvgqkx Salgotarjan Hungary
Lmjan Giwdqrm Hbjttklj Ov Amqpjx Athens Greece
Cpctrd Hvkuatydmsk Rmserhgr Ubofgsfvbsoub Dy Tjhva Tours France
Ugolhbhkgajbqstywotdi Mlffwhjt Aog Munster Germany
Gaonyokeflhddoiqr Vieibqyqc Pyqj Amskvi Eepeqgid Oncadp Kddpng Gyor Hungary
Aruattc Ubtic Sybgjjubz Lylsuy Ds Bprelki Bologna Italy
Uohcuqqpyyxjoy Ccxwbnd Kbfcgkqfv Gdansk Poland
Ukkkwekzvl Mkncv Gleyslu Om Clabxixoy Catanzaro Italy
Hsudbpvp Vpsl dloynkqr Barcelona Spain
Hdjhnqhr Updtfsdpvuuhi dq A Ctcohc A Coruna Galicia Spain
Wicvyzuyul Siridhr Inl Suubdcd Pbl W Pdzdenakm Przemysl Poland
Kvuvrkxka Shaitsw Sstlqamfgqfhqax io Jcvd Pvpxp Id Cracow Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
09.05.2025
Bulgaria Bulgaria
Recruiting
09.05.2025
Finland Finland
Recruiting
09.05.2025
France France
Recruiting
09.05.2025
Germany Germany
Recruiting
09.05.2025
Greece Greece
Recruiting
09.05.2025
Hungary Hungary
Recruiting
09.05.2025
Ireland Ireland
Recruiting
09.05.2025
Italy Italy
Recruiting
09.05.2025
Poland Poland
Recruiting
09.05.2025
Romania Romania
Recruiting
09.05.2025
Spain Spain
Recruiting
09.05.2025
Sweden Sweden
Recruiting
09.05.2025
The Netherlands The Netherlands
Recruiting
09.05.2025

Trial locations

Pembrolizumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this study, it is used both before and after surgery to treat lung cancer.

V940 is an investigational medication being tested in this trial. It is used in combination with pembrolizumab to see if it can improve the effectiveness of the treatment in preventing the return of lung cancer after surgery. The goal is to see if this combination can help patients live longer without the cancer coming back.

Investigated diseases:

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. The disease begins in the tissues of the lungs and can spread to other parts of the body. 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 may affect other organs. The progression and impact of the disease can vary based on the stage at which it is diagnosed.

Trial ID:
2023-506327-29-00
Protocol code:
V940-009
Trial Phase:
Therapeutic confirmatory (Phase III)

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