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Study on the Safety and Effectiveness of Acasunlimab and Pembrolizumab for Patients with Recurrent 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) that has returned or not responded to previous treatments. The study is testing two treatments: GEN1046, also known as Acasunlimab, and Pembrolizumab, which is marketed under the name Keytruda. GEN1046 is a special type of protein designed to help the immune system fight cancer, while Pembrolizumab is a medication that helps the immune system detect and attack cancer cells.

The purpose of the study is to evaluate how well these treatments work, both when used alone and when combined, in patients with this type of lung cancer. Participants will receive the treatments through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will monitor the effects of the treatments over a period of time to see how the cancer responds and to check for any side effects.

Throughout the study, researchers will look at various outcomes, such as how long the cancer stays under control, how long patients live, and any changes in the size of the cancer. The study will also track any side effects or changes in laboratory tests to ensure the safety of the participants. This research aims to provide more information about the effectiveness and safety of these treatments for people with non-small cell lung cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of stage 4 non-small cell lung cancer (NSCLC) and previous treatment history.

A tumor sample is required to confirm PD-L1 expression, which is a protein that may affect how the cancer responds to treatment.

2 treatment assignment

Participants are randomly assigned to receive either GEN1046 alone or in combination with pembrolizumab.

GEN1046 is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein.

3 treatment administration

For those receiving the combination treatment, pembrolizumab is also administered intravenously. The specific dosage and frequency are determined by the study protocol.

The treatment continues as per the schedule outlined in the study, with regular monitoring to assess the response and any side effects.

4 regular monitoring

Participants undergo regular assessments to monitor the effectiveness of the treatment and to check for any adverse effects.

These assessments include imaging tests to measure tumor size and blood tests to evaluate overall health.

5 response evaluation

The primary goal is to evaluate the objective response rate, which measures how well the cancer responds to the treatment.

Secondary goals include assessing the duration of response, time to response, progression-free survival, and overall survival.

6 completion of trial

The trial is expected to continue until March 31, 2027, or until the study objectives are met.

Participants may continue to receive treatment as long as they benefit from it and do not experience unacceptable side effects.

Who Can Join the Study?

  • The person must sign an informed consent form, which is a document that explains the study and confirms their agreement to participate.
  • The person must be at least 18 years old on the day they sign the informed consent form.
  • The person must have a confirmed diagnosis of stage 4 Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer, and must have received at least one previous treatment for their cancer.
  • The person must have a test result showing PD-L1 expression in 1% or more of their tumor cells. PD-L1 is a protein that can affect how the immune system responds to cancer. This test must be done by a specific laboratory or follow certain guidelines.
  • The person must have a measurable disease according to specific criteria used by doctors to assess cancer.
  • The person must have an ECOG performance status of 0 or 1, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The person must have a life expectancy of at least 3 months.
  • The person must have adequate organ and bone marrow function, which means their organs and bone marrow are working well enough to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied, which is Non-Small Cell Lung Cancer.
  • Patients who have not experienced a return or worsening of their cancer after previous treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give their own consent to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of severe allergic reactions to similar medications.

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
Medizinische Hochschule Hannover Hanover Germany
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Lungenfachklinik Immenhausen Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Azienda Sociosanitaria 3 Genoa Italy
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
MD Anderson Cancer Center Madrid Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hospital Clinico Universitario De Valencia Valencia Spain
Med Polonia Sp. z o.o. Poznan Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Justus-Liebig-Universitaet Giessen Giessen Germany
Unite De Recherche Clinique HIA Begin Saint-Mande France
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Universitario Virgen De La Victoria Malaga Spain
Ifikgz Iyomrita Flubnhslegclh Ohotsaulgvq Rome Italy
Lkuau Uqpufuqwqeta Mggzbts Calictn (vpsax Leiden The Netherlands
Lp Mpshxieqh Stgzpy Palermo Italy
Ikplpeqy Bhxaqcad Bordeaux France
Aogufzywr Usi Amsterdam The Netherlands
Eimkgzq Uhbvkquymqms Mvnmpio Cipkikh Rdeveyyel (olozecx Mpk Rotterdam The Netherlands
Nilmgkkw Iwrzfkqg Odhnfmagu Ine Mffza Soykhzoahsxolukwmzduqhqtnnse Ihkiruzj Bgfcuxxf Cracow Poland
Hsukudjx Vawb dpkncfil Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
27.10.2021
Germany Germany
Not recruiting
27.10.2021
Italy Italy
Not recruiting
27.10.2021
Poland Poland
Not recruiting
27.10.2021
Portugal Portugal
Not recruiting
27.10.2021
Spain Spain
Not recruiting
27.10.2021
The Netherlands The Netherlands
Not recruiting
27.10.2021

Trial locations

Investigated drugs:

GEN1046 is an experimental medication being studied for its potential to treat non-small cell lung cancer that has returned or is resistant to previous treatments. It is being tested to see if it can help reduce the size of tumors or slow their growth when used alone.

Pembrolizumab is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer, including non-small cell lung cancer. In this trial, it is being combined with GEN1046 to see if the combination is more effective than using GEN1046 alone.

Investigated diseases:

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically 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 may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.

Trial ID:
2024-513770-22-00
Protocol code:
GCT1046-04
NCT ID:
NCT05117242
Trial Phase:
Therapeutic exploratory (Phase II)

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