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Study of Immunotherapy Combinations with GSK4428859, Dostarlimab, and GSK6097608 for Patients with Advanced Non-Small Cell Lung Cancer

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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). The study is exploring new combinations of treatments for patients who have not received any prior treatment for their advanced or metastatic NSCLC. The treatments being tested include a combination of different immunotherapy drugs. These drugs are designed to help the body’s immune system fight cancer more effectively. The medications involved in this study include a drug with the code name GSK4428859, Jemperli (also known as Dostarlimab), a drug with the code name GSK6097608, and Keytruda (also known as Pembrolizumab).

The purpose of the study is to evaluate how well these new immunotherapy combinations work compared to Pembrolizumab alone in patients with a specific type of NSCLC that shows high levels of a protein called PD-L1. This protein can affect how the immune system responds to cancer. The study will involve participants receiving these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to observe the effects of the treatments on their cancer.

Participants in the study will be monitored closely by healthcare professionals to ensure their safety and to gather information about how the treatments are working. The study aims to provide valuable insights into the effectiveness of these new treatment combinations for NSCLC, potentially leading to better treatment options for patients in the future.

1 joining the study

Upon joining the study, the participant will be required to provide a tumor tissue sample. This sample must be obtained at the time of or after the initial diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC).

The participant must have a tumor with high levels of a protein called PD-L1, which is determined by a specific test.

2 initial assessment

An initial assessment will be conducted to confirm the diagnosis of NSCLC and to ensure the participant meets all eligibility criteria. This includes having measurable disease and adequate organ function.

The participant’s performance status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which measures the ability to perform daily activities.

3 treatment phase

The participant will receive treatment with one of the following medications: JEMPERLI (dostarlimab) or KEYTRUDA (pembrolizumab). Both are solutions for infusion administered intravenously.

The specific dosage and frequency of administration will be determined by the study protocol and the participant’s response to treatment.

4 monitoring and follow-up

Throughout the study, the participant will undergo regular monitoring to assess the response to treatment. This includes imaging tests and other assessments as determined by the study protocol.

The participant will be monitored for any side effects or adverse events related to the treatment. Adjustments to the treatment plan may be made based on these observations.

5 completion of study

The study is estimated to conclude by May 4, 2028. Upon completion, the participant’s overall response to the treatment will be evaluated.

The participant’s health status will continue to be monitored for a specified period after the study to ensure long-term safety and effectiveness of the treatment.

Who Can Join the Study?

  • The patient must be able to give signed informed consent, which means they understand the study and agree to follow its rules.
  • If the patient is a woman who can have children, she must agree to use effective birth control and not be pregnant or breastfeeding. She also agrees not to donate eggs during the study.
  • The patient must be at least 18 years old or the legal age of consent in their area.
  • The patient must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced and cannot be removed by surgery, or has spread to other parts of the body.
  • The patient must not have received previous treatment for their advanced or spread NSCLC.
  • The patient must provide a sample of their tumor tissue taken at the time of or after their diagnosis.
  • The patient’s tumor must have a high level of PD-L1, a protein that can affect the immune system’s response to cancer.
  • The patient must have a disease that can be measured using a specific method called RECIST 1.1, which helps doctors track the size of tumors.
  • The patient must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
  • Patients whose cancer does not have a high level of PD-L1. PD-L1 is a protein that can affect how the immune system fights cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Koranyi National Institute For Pulmonology Budapest Hungary
Frisius Heerenveen The Netherlands
University Hospital Jena KöR Jena Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Hospital Cuf Descobertas S.A. Lisbon Portugal
Oulu University Hospital Oulu Finland
Medisch Spectrum Twente Enschede The Netherlands
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
AORN San Giuseppe Moscati Avellino Avellino Italy
Vaasa Central Hospital Vaasa Finland
General University Hospital Of Larissa Larissa Greece
Matrai Gyogyintezet Gyongyos Hungary
Alexandra Hospital Athens Greece
Hospital Da Luz S.A. Lisbon Portugal
St. Antonius Ziekenhuis Nieuwegein The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Cliniche Gavazzeni S.p.A. Bergamo Italy
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
St. Luke’s Hospital S.A. Thessaloniki Greece
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Pirkanmaan hyvinvointialue Tampere Finland
Centre Hospitalier Universitaire De Caen Normandie Caen France
Usgmaskuwmbxsnrvrrajs Ejryb Aia Essen Germany
Sifcykamd Mmnhzbp Zafksqeowt Groningen The Netherlands
Ixwfrllu Cwwrlv Djhwxuxhhxyexkdqb L'hospitalet De Llobregat Spain
Hczyqqgb Urlhyafwpknlh Dh Bfuitpp Badajoz Spain
Dwsiivbwltdr Cckfedc Octiozdjc Pcdohsexxyea I Hkaeyblolfo Wroclaw Poland
Aulzihs Uykx 9 Sqhajzirj Legnago Italy
Ulqwavzgyk Ot Afkqgye Edegem Belgium
Lfsev Gwejbza Hcjdzslt Ox Aftmwx Athens Greece
Axcacmp Umi Thqdquq nokq ohqhf Leghorn Italy
Acwnvd Mewupnq Cbqcsj Sjlq Thessaloniki Greece
Fzxyqlusw Pfgy Lg Ieaamgwlfjvpl Bhavgvmpj Dhf Hifjmtui Udqyqrcihbabr Lo Pqg Madrid Spain
Hjiktdmf Vizr dzgpqzeq Barcelona Spain
Ientgicz Pgsqyzzfsrwxjby Cwjijr Ccjjdd Marseille France
Uoiwxtksaw Gasmmpr Hffofvik Aurqrde Athens Greece
Hcaarqoq Uonydmtozxgtse Seytpvknnf &gbzecx Hxrzdvh de Hcfvpmoxigr 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
09.02.2023
Finland Finland
Not recruiting
09.02.2023
France France
Not recruiting
09.02.2023
Germany Germany
Not recruiting
09.02.2023
Greece Greece
Not recruiting
09.02.2023
Hungary Hungary
Not recruiting
09.02.2023
Italy Italy
Not recruiting
09.02.2023
Poland Poland
Not recruiting
09.02.2023
Portugal Portugal
Not recruiting
09.02.2023
Spain Spain
Not recruiting
09.02.2023
The Netherlands The Netherlands
Not recruiting
09.02.2023

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is specifically used for treating non-small cell lung cancer that has a high level of a protein called PD-L1.

Novel Immunotherapy Combinations are new treatments being tested in this trial. These combinations aim to enhance the body’s immune response against cancer cells. The goal is to find more effective ways to treat non-small cell lung cancer by using these new combinations alongside or instead of existing treatments like pembrolizumab.

Investigated diseases:

Lung Cancer, Non-Small Cell – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is the most common form of lung cancer, accounting for about 85% of cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. Non-small cell lung cancer often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:
2023-505057-40-00
Protocol code:
213824
NCT ID:
NCT05565378
Trial Phase:
Therapeutic exploratory (Phase II)

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