Study of Rilvegostomig (AZD2936) for Adults with Advanced or Metastatic 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), specifically in its advanced stages. The study involves a treatment called Rilvegostomig, also known by its code name AZD2936. This treatment is a special kind of protein designed to target and block certain pathways in the body that cancer cells use to grow. The purpose of the study is to evaluate the safety and effectiveness of this treatment in patients with advanced or metastatic NSCLC.

Participants in the study will receive the treatment as a solution through an infusion, which means it will be administered directly into the bloodstream. The study will be conducted in different parts, each focusing on different aspects of the treatment, such as its safety and how well it works against the cancer. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatment. The study will also monitor how the body processes the treatment and any potential side effects that may occur.

The trial will take place over several years, allowing researchers to gather comprehensive data on the treatment’s impact on the disease. Throughout the study, participants will undergo regular check-ups and tests to assess their health and the progress of the treatment. The ultimate goal is to determine if Rilvegostomig can be a safe and effective option for treating advanced stages of Non-small Cell Lung Cancer.

1 joining the study

Upon joining the study, the patient provides written informed consent. This confirms understanding of the study and agreement to participate.

Eligibility is confirmed based on criteria such as age (18 or above), adequate organ function, and specific medical conditions related to non-small cell lung cancer (NSCLC).

2 initial assessment

An initial assessment is conducted to evaluate the patient’s health status. This includes checking vital signs and laboratory parameters.

The patient’s performance status is assessed using the ECOG scale, which measures daily living abilities.

3 treatment administration

The patient receives the medication AZD2936, which contains the active substance rilvegostomig. This is administered as a solution for infusion through intravenous use.

The dosage and frequency of administration are determined based on the specific part of the study the patient is enrolled in.

4 monitoring and follow-up

Throughout the study, the patient is monitored for safety and tolerability of the medication. This includes tracking any adverse events or immune-mediated reactions.

Regular assessments are conducted to evaluate the medication’s effect on the cancer, including measuring tumor response and progression.

5 study completion

The study is estimated to conclude by January 1, 2026. Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

You must provide written informed consent, which means you agree to participate after understanding the study details.
Your bone marrow, liver, and kidney must be working well enough to participate.
You need to be 18 years or older.
If you are in Part A or Part B, you must have unresectable stage III or stage IV non-small cell lung cancer (NSCLC) that cannot be cured with surgery or radiation. If you are in Part C or Part D, you must have stage IV NSCLC that cannot be cured with surgery or radiation.
You need to have a documented PD-L1 expression, which is a specific protein found in your cancer cells, confirmed by a local test.
If you are in Part A or Part B, your cancer must have progressed during treatment with a regimen that includes a checkpoint inhibitor (CPI), a type of cancer treatment.
If you are in Part C or Part D, you must not have had any previous immuno-oncology (IO) treatment for metastatic NSCLC.
You need to have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
You should have a life expectancy of at least 12 weeks when you join the study.
You must have at least one measurable lesion according to specific criteria used to assess cancer size and response to treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have had a recent major surgery or are recovering from one.
Patients who have an active infection that requires treatment.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to similar medications.
Patients who are currently participating in another clinical trial.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Lhyvk Uvpraltxiqpa Msfewgm Cjljojy (xywrz	Leiden	The Netherlands
Uvwrhbyvuodi Mxnistx Cjknmjq Gjlrcqwng	Groningen	The Netherlands
Hqpkitcj Vecu dqvkdkkj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.02.2024
Denmark	Not recruiting	28.02.2024
France	Not recruiting	28.02.2024
Spain	Not recruiting	28.02.2024
The Netherlands	Not recruiting	28.02.2024

Trial locations

Investigated drugs:

Rilvegostomig

AZD2936 is a bispecific antibody designed to target two proteins, TIGIT and PD-1, which are involved in the immune system’s response to cancer. By blocking these proteins, AZD2936 aims to enhance the body’s ability to fight cancer cells, particularly in patients with advanced or metastatic non-small cell lung cancer. This medication is being studied to determine its safety, how it is processed in the body, its effects on the immune system, and its effectiveness in treating cancer.

Investigated diseases:

Lung neoplasm malignant

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that has spread beyond the lungs to other parts of the body. It is characterized by the uncontrolled growth of abnormal cells in the lung tissues. As the disease progresses, it can invade nearby tissues and organs, making it more challenging to treat. Symptoms may include persistent cough, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.

Metastatic Non-Small Cell Lung Cancer – This form of lung cancer occurs when cancer cells from the lung spread to other parts of the body, such as the brain, bones, or liver. It is a progression of non-small cell lung cancer where the cancerous cells travel through the bloodstream or lymphatic system. Symptoms can vary depending on the organs affected by the metastasis. Common signs include weight loss, fatigue, and pain in the affected areas. The spread of cancer cells makes it more complex to manage and treat.

Stage III Unresectable Non-Small Cell Lung Cancer – This stage of lung cancer indicates that the cancer has spread to nearby tissues or lymph nodes but cannot be surgically removed. The tumor may be too large or located in a position that makes surgery risky. Symptoms often include persistent cough, shortness of breath, and chest pain. The disease may also cause swelling in the face or neck due to pressure on blood vessels. Treatment focuses on controlling the growth and spread of the cancer.

Stage IV Non-Small Cell Lung Cancer – This is the most advanced stage of non-small cell lung cancer, where the cancer has spread to distant parts of the body. It is characterized by the presence of tumors in organs beyond the lungs, such as the brain or liver. Symptoms can be widespread and include severe fatigue, weight loss, and pain in various parts of the body. The disease is often diagnosed through imaging tests that reveal the extent of the spread. Management focuses on alleviating symptoms and improving quality of life.

Trial ID:

2023-508262-15-00

Protocol code:

D7020C00001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Rilvegostomig (AZD2936) for Adults with Advanced or Metastatic Non-Small Cell Lung Cancer

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