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Study of Durvalumab in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study is focused on treating a type of lung cancer known as non-small cell lung cancer that is either advanced or has spread to other parts of the body. The lung cancer is at stages IIIb to IV, which means it is more advanced. Patients who are part of this study must have already received at least two different previous treatments, one of which included chemotherapy with a platinum-based drug.

The treatment being investigated is a medicine called Medi4736, which is also known by the name Durvalumab. It is given as an infusion, which means it is administered through a vein. The main goal of the study is to see how effective Durvalumab is in patients whose lung cancer cells show certain characteristics, like having a specific protein called PD-L1 present in 25% or more of the tumor cells. The treatment aims to improve the response of the cancer to the drug, and several aspects of response, such as how long the effects last and how it impacts patient survival, will be evaluated.

Participants in this study will receive treatment without any comparison to a placebo or other drugs. The study is designed to observe the direct effects of Durvalumab in various groups of patients to understand its potential benefits in controlling lung cancer under these specific conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide signed, written, and dated informed consent. This is required before any study-specific procedures can begin.
Female patients must provide evidence of post-menopausal status or a negative pregnancy test if pre-menopausal.
The patient must demonstrate adequate organ and marrow function and be at least 18 years old.
Step 2
Eligibility confirmation
The patient must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is either locally advanced or metastatic.
The patient must have received at least two prior systemic treatment regimens, including one platinum-based chemotherapy regimen.
The patient's tumor sample must be positive for PD-L1, with at least 25% of tumor cells showing membrane staining for Cohorts 1 and 2, or at least 90% for Cohort 3.
The patient must have measurable disease and a life expectancy of at least 12 weeks from Day 1 of the trial.
The patient must have a World Health Organization (WHO) Performance Status of 0 or 1.
Step 3
Treatment administration
The patient will receive the medication durvalumab, known by the brand name IMFINZI, which is a concentrate for solution for infusion.
The medication is administered intravenously, meaning it is given through a vein.
The specific dosage, frequency, and duration of administration will be determined by the study protocol and the patient's specific cohort.
Step 4
Evaluation of response
The primary endpoint of the study is the objective response rate (ORR), which will be evaluated approximately 24 weeks after the last patient is enrolled in each cohort.
Secondary endpoints include duration of response, progression-free survival, disease control rate, overall survival, and deep sustained response.
The data cut-off for secondary efficacy endpoints will occur approximately 8 months after recruitment ends, with a final analysis of overall survival approximately 12 months after the last patient is enrolled.

Who can join the trial?

11 criteria

You must provide a signed, written, and dated consent form before any study procedures begin.
If you are a woman, you need to show proof of being post-menopausal or have a negative pregnancy test if you are pre-menopausal.
Your organs and bone marrow must be working well enough to participate.
You must be 18 years old or older, whether you are male or female.
You need to have either a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) or have the disease come back or get worse after previous treatments for advanced disease.
You must have had at least two different treatments for NSCLC before.
Your disease must have gotten worse or come back after having a platinum-based chemotherapy and at least one other treatment.
Your tumor sample must be PD-L1 positive, meaning at least 25% of the tumor cells show a specific marker, or at least 90% for certain groups.
You must have a disease that can be measured by the study team.
You should have a life expectancy of at least 12 weeks from the start of the study.
Your ability to perform daily activities should be rated as 0 or 1 on the World Health Organisation (WHO) Performance Status scale, which means you are fully active or have some symptoms but can still do light work.

Who cannot join the trial?

6 criteria

Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate. This study is only for those with this specific type of lung cancer.
Patients who have not reached the required stage of cancer, which is Stage IIIB-IV, are excluded. This means the cancer must be advanced or have spread to other parts of the body.
Patients who do not have PD-L1 positive tumors are excluded. PD-L1 is a protein that can be found on the surface of cancer cells, and it must be present in a certain amount for the patient to be eligible.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
Patients who are considered part of a vulnerable population may be excluded. This refers to groups of people who might need special protection or care.

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Verified sites

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Grand Hopital De Charleroi
Responsive
Charleroi, Belgium

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Investigated drugs

MEDI4736 is a medication being studied for its effectiveness in treating patients with advanced stages of non-small cell lung cancer. This medication is designed to help the body's immune system recognize and attack cancer cells. It is specifically being tested in patients who have already undergone at least two previous treatments, including one that involved platinum-based chemotherapy. The study aims to determine how well this medication works in patients whose cancer cells show a certain level of a protein called PD-L1.

Durvalumab

What is already known about the treatment

MEDI4736 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic non-small cell lung cancer. It is not yet fully approved for widespread medical use, but it is gaining attention in medical literature for its potential benefits. The main therapeutic indication for MEDI4736 is in patients who have already undergone at least two prior systemic treatments, including one platinum-based chemotherapy regimen. At the molecular level, MEDI4736 works by targeting and inhibiting the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the body's natural defenses against cancer.

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 characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. In its locally advanced or metastatic stages (Stage IIIB-IV), the cancer has spread beyond the lungs to nearby tissues or other parts of the body. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. As the cancer advances, it may affect the function of the lungs and other organs. The disease is often associated with smoking, but non-smokers can also develop it.