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Study on the Safety and Effects of ATL001 and Pembrolizumab in Adults with Advanced 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 trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study is exploring a new treatment approach using a personalized therapy called ATL001, which is a type of cell therapy. This therapy is designed to target specific mutations found in cancer cells. The study will also look at how ATL001 works when used alone and in combination with another medication called pembrolizumab, which is already used in cancer treatment.

The main goal of the study is to assess the safety and how well patients tolerate ATL001 as a treatment. Participants in the study will receive the treatment through an infusion, which means the medication is given directly into the bloodstream. The study will monitor patients over time to see how their cancer responds to the treatment and to check for any side effects. The study will also compare the effects of the treatment with those of a placebo.

Throughout the study, patients will have regular check-ups to track their health and the progress of their cancer. The study will measure changes in tumor size and overall health outcomes, such as how long patients live without their cancer getting worse. This research aims to provide new insights into treating non-small cell lung cancer and potentially offer new options for patients with this type of cancer.

The research process

The trial runs in 8 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 written informed consent to participate.
Eligibility is confirmed based on criteria such as age, medical condition, and previous treatments.
Step 2
Initial assessments
Initial assessments include a review of medical history and a physical examination.
Blood and tumor tissue samples are collected for analysis.
Step 3
Tissue procurement
Tissue is collected from accessible sites of disease to manufacture ATL001.
This procedure may require a general anesthetic.
Step 4
Lymphodepletion
Lymphodepletion involves the administration of medications to prepare the body for ATL001 treatment.
Medications used include fludarabine and cyclophosphamide.
Step 5
Administration of ATL001
ATL001 is administered as a dispersion for infusion through intravenous use.
The patient's health is monitored closely during this period.
Step 6
Combination therapy with pembrolizumab
In some cases, ATL001 is combined with pembrolizumab, a solution for infusion.
Pembrolizumab is administered intravenously.
Step 7
Follow-up assessments
Regular follow-up assessments are conducted to monitor the patient's response to treatment.
These assessments include imaging studies to evaluate changes in tumor size.
Step 8
End of study participation
The study is estimated to conclude by July 31, 2027.
Final assessments are conducted to gather data on the patient's overall response and health status.

Who can join the trial?

16 criteria

Patient must be between 18 and 75 years old at the screening visit.
Patient should have a life expectancy of at least 6 months at the time of tissue collection.
Patient must have advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body. The cancer must have either worsened after standard treatments or the patient cannot receive standard treatments due to side effects.
Patient must have a measurable disease according to specific medical guidelines before starting certain treatments.
Patient must be considered well enough by the doctor to receive the study treatment, based on a performance status scale (ECOG 0-1).
Before receiving the study treatment, the patient must have been treated with a type of medication called a PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least four doses.
Female patients in a specific group must agree to use effective birth control during treatment with pembrolizumab and for at least 4 months after the last dose. They must also agree to take a pregnancy test before each treatment session.
Patient must have given written informed consent to participate in the study.
Patient must have a confirmed diagnosis of non-small cell lung cancer that is related to smoking.
Patient must be medically fit to undergo all study procedures, including blood and tumor tissue collection, and to receive specific medications at the required doses and schedules.
Patient must be considered capable of following the study protocol by the doctor.
Patient must have adequate organ function, as shown by specific blood test results.
Female patients who can have children must agree to use a highly effective method of birth control during the study and for at least 12 months after receiving the study treatment. Male patients who are not sterilized and have a female partner who can have children must use an acceptable method of birth control from the time of screening and for at least 6 months after receiving the study treatment.
To be eligible for tissue collection, the patient must fall into one of the following groups:
- Patients with advanced stage NSCLC who have accessible sites of disease suitable for tissue collection before starting standard treatment.
- Patients with advanced stage NSCLC who have received or are receiving standard treatments and have accessible sites of residual disease suitable for tissue collection.
- Other patients with advanced stage disease for whom no other approved treatments are available may be considered on a case-by-case basis.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides non-small cell lung cancer cannot participate. Non-small cell lung cancer is a common type of lung cancer.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are usually specified by the study.
Patients who are taking medications that might interfere with the study cannot participate. These medications are usually specified by the study.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of allergic reactions to the study drugs cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

ATL001
is a type of therapy that uses special immune cells called T cells. These T cells are designed to recognize and attack cancer cells in patients with advanced non-small cell lung cancer. The goal of using ATL001 is to see if it can safely help the immune system fight the cancer.
Pembrolizumab
is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. In this trial, pembrolizumab is used in combination with ATL001 to see if the two together can improve the treatment of advanced non-small cell lung cancer.

What is already known about the treatment

ATL001
This medication is administered through infusion and is currently being studied in clinical trials for its safety and effectiveness in treating advanced non-small cell lung cancer. It is in the early stages of research, specifically in phase I/IIa trials. The main therapeutic indication is for patients with this type of lung cancer. ATL001 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy agent.
Pembrolizumab
This medication is given as an intravenous infusion and is already approved for use in various cancers, including non-small cell lung cancer. It is being studied in combination with ATL001 to evaluate enhanced safety and effectiveness. Pembrolizumab is used to treat several types of cancer by blocking a protein called PD-1, which helps the immune system attack cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors.

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 all 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 difficulty breathing. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. The progression can vary significantly depending on the subtype and individual patient factors.