Study Comparing Zimberelimab and Domvanalimab with Pembrolizumab 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 treatments for Non-Small Cell Lung Cancer (NSCLC), which is a common type of lung cancer. The study involves comparing two different treatment approaches. One approach uses a combination of two medications, Zimberelimab (also known as AB122) and Domvanalimab (also known as AB154). The other approach uses a medication called Pembrolizumab, which is also known by the brand name Keytruda. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective the combination of Zimberelimab and Domvanalimab is compared to Pembrolizumab in treating patients with advanced stages of NSCLC. The study will involve patients who have not received prior treatment for their cancer and have a specific characteristic called high PD-L1 expression, which is a protein found on the surface of some cancer cells. This study will help determine which treatment option might be more beneficial for patients with this type of lung cancer.

Participants in the study will receive their assigned treatment and will be monitored over a period of time to assess their overall survival and any side effects they may experience. The study will also look at how the treatments affect the patients’ quality of life and any changes in their symptoms. The results of this study will provide valuable information about the potential benefits and risks of these treatments for people with advanced NSCLC.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of non-small cell lung cancer with high PD-L1 expression and ensuring adequate organ function.

A performance status score is evaluated to ensure it is either 0 or 1, indicating the ability to carry out daily activities with minimal assistance.

2 treatment assignment

Participants are assigned to one of two treatment groups. One group receives a combination of zimberelimab and domvanalimab, while the other group receives pembrolizumab.

All medications are administered through intravenous infusion.

3 treatment administration

For the zimberelimab and domvanalimab group, the medications are given as a solution for infusion. The specific dosage and frequency are determined by the study protocol.

For the pembrolizumab group, the medication is provided as a concentrate for solution for infusion, with dosage and frequency also specified by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess overall survival and progression-free survival. This includes imaging tests and clinical evaluations.

Participants are observed for any treatment-emergent adverse events and changes in vital signs or laboratory parameters.

5 symptom assessment

The time to first symptom deterioration is evaluated using a specific questionnaire designed for non-small cell lung cancer.

This assessment helps in understanding the impact of the treatment on quality of life.

6 study completion

The study is estimated to conclude by February 29, 2028. Participants will continue to receive treatment and monitoring until the study’s end date or until specific criteria for discontinuation are met.

Who Can Join the Study?

The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC), which can be either squamous or non-squamous. The cancer should be in an advanced stage and not previously treated.
The cancer must show high levels of a protein called PD-L1 (at least 50% expression), as determined by a specific laboratory test.
The patient should have a good general health status, with an ECOG performance status score of 0 or 1. This score measures how well the patient can perform daily activities.
There must be at least one cancer lesion that can be measured according to specific medical guidelines called RECIST v1.1.
The patient must have normal functioning of their organs and bone marrow.
If the patient has cancer that has spread to the brain or the protective layers around the brain (meninges), they must meet certain conditions:
- No worsening of brain-related symptoms for at least 4 weeks before starting the study treatment.
- If the brain metastases were treated before, they must be stable for at least 4 weeks before joining the study.
- Stable brain disease means no new or growing brain tumors and no need for steroids for brain issues for at least 14 days before starting the study treatment.
- If brain tumors were surgically removed or treated with radiation, the treatment must have been completed at least 4 weeks (or 2 weeks for certain types of radiation) before starting the study treatment.
- Patients with a condition called carcinomatous meningitis cannot participate, even if they are stable.
Both male and female patients can participate.
Patients must be within a certain age range, typically adults.

Who Cannot Join the Study?

Patients with other types of cancer that are not related to lung cancer cannot participate.
Patients who have received certain treatments for lung cancer recently may not be eligible.
Patients with serious health conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with allergies to the study medications cannot participate.
Patients who cannot follow the study procedures or attend the required visits may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Intercommunal Creteil	Creteil	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hopital Ambroise Pare	Boulogne-Billancourt	France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Consorci Sanitari Del Maresme	Mataró	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
MD Anderson Cancer Center	Madrid	Spain
Beaumont Hospital	Dublin	Ireland
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Gtnodkz Hoywcgyo Ox Pxrtcd Avbtg Abmeepm	Patras	Greece
Ciijgw Hqmtbssadaq Du Cplntd	Chauny	France
Hsastvof Ulgvrgpucmfbu Dz Lq Pmskmgma	Madrid	Spain
Hjkelotx Vphu dqiyxyxe	Barcelona	Spain
Ugjwpqdfxf Gcykwzn Hzkrplxk Awfnmfy	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.08.2023
Greece	Not recruiting	31.08.2023
Ireland	Not recruiting	31.08.2023
Spain	Not recruiting	31.08.2023

Trial locations

Investigated drugs:

Zimberelimab is a medication being studied for its potential to help the immune system fight cancer. It is used in combination with other treatments to see if it can improve outcomes for patients with certain types of lung cancer.

Domvanalimab is another medication that is being tested alongside zimberelimab. It is designed to work with the immune system to target and destroy cancer cells more effectively.

Pembrolizumab is a well-known medication that helps the immune system attack cancer cells. It is often used in treating various types of cancer, including lung cancer, and is being compared to the combination of zimberelimab and domvanalimab in this study.

Investigated diseases:

Non-small cell lung cancer

Squamous Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the squamous cells, which are flat cells that line the inside of the airways in the lungs. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease typically progresses by forming a mass in the lung that can grow and potentially spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing as the tumor grows.

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease progresses by forming tumors in the lung tissue, which can grow and spread to other parts of the body. Symptoms often include a persistent cough, chest pain, and shortness of breath.

Non-squamous Non-Small Cell Lung Cancer – This refers to types of non-small cell lung cancer that do not originate in squamous cells. It includes adenocarcinoma and large cell carcinoma, which are common subtypes. The disease progresses by forming tumors in the lung that can grow and potentially spread to other areas. Symptoms may include coughing, chest pain, and breathing difficulties.

Lung Cancer – This is a disease characterized by uncontrolled cell growth in the tissues of the lung. It can be classified into two main types: non-small cell lung cancer and small cell lung cancer. The disease progresses by forming tumors that can invade nearby tissues and spread to other parts of the body. Common symptoms include a persistent cough, chest pain, and difficulty breathing.

Trial ID:

2022-503071-28-00

Protocol code:

ARC-10

NCT ID:

NCT04736173

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Zimberelimab and Domvanalimab with Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?