Study on Durvalumab for Patients with Poor General Condition and Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer, in patients who have a poor general health status. The treatment being tested is called Durvalumab, also known by its code name MEDI4736. Durvalumab is a type of medication known as an anti-PD-L1 monoclonal antibody, which is a protein designed to help the immune system fight cancer cells. The purpose of the study is to evaluate the safety and effectiveness of Durvalumab in patients who have not received previous treatment for their advanced stage of NSCLC and have high levels of a protein called PD-L1 in their tumors.

The study will involve patients receiving Durvalumab through an infusion, which is a method of delivering medication directly into the bloodstream. The treatment will be given over a period of up to 24 months. During the study, researchers will monitor the patients’ health and any side effects they may experience. The goal is to see if Durvalumab can improve the patients’ overall health and extend their survival.

This trial is particularly important because it includes patients who are often not eligible for other clinical trials due to their poor health status. By participating in this study, researchers hope to find out if Durvalumab can be a safe and effective treatment option for these patients, potentially leading to better outcomes and longer lives.

1 initiation of treatment

Upon joining the study, treatment begins within 7 days. The treatment involves the administration of durvalumab, a medication used to treat non-small cell lung cancer.

Durvalumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The specific dosage and frequency of administration will be determined by the healthcare provider based on individual needs and response to treatment.

2 treatment monitoring

Throughout the treatment, regular visits are scheduled to monitor the body’s response to durvalumab. This includes laboratory tests and imaging studies to assess the size and progression of the tumor.

The primary goal is to evaluate the safety and effectiveness of the treatment, ensuring that any side effects are managed promptly.

3 evaluation of treatment response

After 8 weeks of treatment, an assessment is conducted to determine the disease control rate. This involves checking if the cancer has responded to the treatment or remained stable.

The evaluation includes measuring the objective response rate, which indicates the percentage of patients whose cancer has shrunk or disappeared after treatment.

4 ongoing assessment

The study continues to monitor progression-free survival (PFS) and overall survival (OS) rates. PFS refers to the length of time during and after treatment that the patient lives with the disease without it getting worse. OS measures the time from the start of treatment until death from any cause.

Quality of life is also assessed using specific questionnaires to understand the impact of the treatment on daily living and well-being.

5 completion of trial

The trial is expected to conclude by October 2025. At the end of the study, a comprehensive analysis of the data collected will be performed to determine the overall effectiveness and safety of durvalumab in treating non-small cell lung cancer in patients with poor general condition.

Who Can Join the Study?

Participants must sign a written consent form, showing they understand and agree to the study. They should be willing to attend scheduled visits and follow the treatment and testing plan.
Participants can have limited radiation treatment for pain relief within 2 weeks before starting the study drug, as long as the lungs are not affected and the treated area is not used to measure the tumor.
Participants must be between 18 and 75 years old.
Participants must have a tumor that can be measured using a CT scan, following specific guidelines.
Participants should have a life expectancy of more than 8 weeks, as judged by the study doctor.
Participants must have adequate biological functions, including:
- Neutrophils (a type of white blood cell) of at least 1500 per mm³
- Platelets (cells that help with blood clotting) of at least 75,000 per mm³
- Hemoglobin (a protein in red blood cells) of at least 9 g/dL
- Creatinine clearance (a measure of kidney function) greater than 40 mL/min
- AST and ALT (liver enzymes) levels within specific limits, unless liver metastases are present
- Serum bilirubin (a substance made by the liver) within specific limits, with exceptions for certain conditions
Other required tests must be completed within the specified timeframes.
Treatment must start within 7 days of joining the study.
Female participants must show evidence of being post-menopausal or have a negative pregnancy test if they are of childbearing age. Post-menopausal status is defined by specific criteria, including age and medical history.
Participants of childbearing potential must use effective birth control methods if sexually active, starting before the first dose and continuing for 90 days after the last dose. Certain methods like periodic abstinence are not acceptable.
Participants must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), with enough tumor material for testing.
The tumor must show PD-L1 expression in at least 25% of cells, as tested by a local lab.
Tumor samples must be available for further testing.
Participants must not have specific genetic changes, such as EGFR mutation or ALK gene rearrangement.
The cancer must be at Stage IV, which means it has spread to other parts of the body.
Participants must have an ECOG performance status of 2 or 3, indicating their ability to perform daily activities, despite receiving the best possible symptom treatment.
Participants must weigh more than 30 kg.
Participants must not have received prior systemic cancer treatment for advanced or metastatic disease, including chemotherapy, immunotherapy, or specific inhibitors. Previous treatments for earlier stages of cancer are allowed.

Who Cannot Join the Study?

Patients with a poor general status, meaning their overall health is not good enough to safely participate in the study.
Patients who do not have non-small cell lung cancer, which is a specific type of lung cancer.
Patients who do not have tumors that are highly PD-L1 expressing. PD-L1 is a protein that can be found on cancer cells, and high levels may affect how the cancer responds to certain treatments.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial group. This means the study is looking for participants with specific characteristics or conditions.
Patients who are not male or female, as the study includes both genders.
Patients who are not considered part of a vulnerable population. This refers to groups of people who might need special protection or consideration in research studies.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Colmar	Colmar	France
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier De Pau	Pau	France
Asbxoeofam Pxyjjseb Hshmvkfo Dj Miuhuavrk	Marseille	France
Bhxmxzgq Uhzebpticn Hbhzcvrh Crewda	Besançon	France
Cwvlqn Hgiaynhqpiq Rsnctoiw Utyvuwehblfzf De Tmjnz	Tours	France
Gembcv Hyvoghhvbad Ufppniuoarjaz Pwstm Pglbjesvmaq Eq Nkxdgvttodop	Paris	France
Chogcn Hinpokppmng Rzpjueux Dxkvyfrnxcpcay	Angers	France
Htodkemw Uzqjqluvcjfprl Sjnyflwxum &uzdqmz Hmjzbku da Hjdomgamsuv	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	25.10.2019

Trial locations

Investigated drugs:

Durvalumab

Durvalumab is a medication used in this clinical trial. It is a type of immunotherapy known as an anti-PD-L1 monoclonal antibody. Durvalumab works by helping the immune system recognize and attack cancer cells. In this trial, it is being tested for its safety and effectiveness in patients with stage IV Non-Small Cell Lung Cancer who have not received previous treatment and have high levels of PD-L1 expression. These patients typically have a poorer performance status, meaning they have more difficulty with daily activities, and are often excluded from other clinical trials. The goal is to see if Durvalumab can improve their condition and help them live longer.

Investigated diseases:

Non-small cell lung cancer stage IV

Poor general status – This condition refers to an overall decline in a person’s physical health and well-being. It can manifest as fatigue, weakness, weight loss, and a reduced ability to perform daily activities. The progression of poor general status can vary depending on the underlying causes, which may include chronic diseases, malnutrition, or other health issues. Individuals with poor general status may experience a gradual worsening of symptoms, impacting their quality of life. It is often a concern in patients with serious illnesses, as it can affect their ability to tolerate treatments. Monitoring and addressing the underlying causes are crucial to managing this condition.

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 form of lung cancer, accounting for about 85% of cases. The disease typically progresses slowly compared to small cell lung cancer, but it can spread to other parts of the body if not treated. Symptoms may include a persistent cough, chest pain, shortness of breath, and unexplained weight loss. The progression of non-small cell lung cancer depends on the stage at diagnosis and other individual factors. Early detection is important for managing the disease effectively.

Trial ID:

2024-515943-44-00

Protocol code:

IFCT-1802

NCT ID:

NCT04108026

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Durvalumab for Patients with Poor General Condition and Advanced Non-Small Cell Lung Cancer

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