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Study on the Effectiveness and Safety of Pembrolizumab, Canakinumab, and Chemotherapy for Untreated Advanced Non-Small Cell Lung Cancer Patients

Verified siteRegistered drugNo placebo

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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 non-small cell lung cancer (NSCLC), which is a common type of lung cancer. The study is investigating the effectiveness and safety of a treatment combination that includes pembrolizumab, a type of immunotherapy, along with a standard chemotherapy regimen known as platinum-based doublet chemotherapy. The trial is also examining the potential benefits of adding canakinumab, a medication that is administered as a solution for injection, to this treatment combination. Canakinumab is being studied under the code name ACZ885.

The purpose of the study is to determine if the addition of canakinumab to the existing treatment can improve outcomes for patients with locally advanced or metastatic NSCLC. The study is designed to compare two groups of patients: one group receiving pembrolizumab and chemotherapy with canakinumab, and another group receiving pembrolizumab and chemotherapy without canakinumab. Some patients may receive a placebo instead of canakinumab. The trial will assess how long patients live without their cancer getting worse and their overall survival.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess the safety and effectiveness of the treatment. The study will also look at the side effects and any changes in health indicators such as laboratory tests and vital signs. This trial aims to provide valuable information on whether adding canakinumab to the treatment regimen can offer additional benefits to patients with NSCLC.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as having non-small cell lung cancer (NSCLC) that is locally advanced or metastatic, measurable disease, known PD-L1 status, and an ECOG performance status of 0 or 1.
Step 2
Safety run-in phase
This initial phase aims to determine the recommended dose of canakinumab when combined with pembrolizumab and platinum-based chemotherapy.
During the first 42 days, the focus is on monitoring for any dose-limiting toxicities.
Step 3
Treatment administration
The treatment involves the administration of canakinumab via subcutaneous injection and pemetrexed through intravenous infusion.
The exact dosage and frequency are determined during the safety run-in phase.
Step 4
Double-blind, randomized phase
Participants are randomly assigned to receive either the treatment with canakinumab or a placebo, in addition to pembrolizumab and chemotherapy.
This phase is designed to compare progression-free survival and overall survival between the two groups.
Step 5
Monitoring and assessments
Regular assessments are conducted to monitor the concentration of the drugs, the presence of anti-drug antibodies, and any adverse events.
The study also evaluates the overall response rate, disease control rate, and duration of response.
Step 6
Quality of life evaluations
Participants complete questionnaires to assess symptoms such as chest pain, cough, and shortness of breath, as well as overall quality of life.
These evaluations help determine the impact of the treatment on daily living.
Step 7
Study completion
The study is estimated to conclude by June 2027, with ongoing monitoring and data collection throughout the trial period.

Who can join the trial?

8 criteria

The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC).
The cancer must be confirmed through a test called histology, which examines tissue under a microscope, and it should be either locally advanced or has spread to other parts of the body (metastatic).
The patient must have a cancer that can be measured using a specific method called RECIST 1.1, which is a set of rules to measure how cancer responds to treatment.
The patient must have a known PD-L1 status, which is a test to see if certain proteins are present on the cancer cells.
The patient must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, where 0 means fully active and 1 means some symptoms but still able to do light work.
Other specific criteria defined in the study protocol may also apply.
Both male and female patients can participate.
The study includes patients who may be considered vulnerable.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides non-small cell lung cancer cannot participate. Non-small cell lung cancer is a type of lung cancer that is different from small cell lung cancer.
Patients who have not reached the age required for the study cannot participate. The study is for adults only.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate. These conditions are not specified but could include serious heart, liver, or kidney problems.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
Patients who have an active infection that requires treatment cannot participate.
Patients who have a known allergy to any of the study medications cannot participate.
Patients who have received certain treatments for cancer recently, such as chemotherapy or radiation, may not be eligible.
Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body, may not be eligible.

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Verified sites

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

Complejo Hospitalario Universitario Insular Materno Infantil
Verified
Las Palmas De Gran Canaria, Spain
Kliniken der Stadt Koeln gGmbH
Verified
Cologne, Germany

Trial locations

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Investigated drugs

Pembrolizumab
is a medication used in this trial to help the body's immune system fight cancer cells. It works by blocking a specific protein on cancer cells, allowing the immune system to better detect and attack them. This medication is often used in combination with other treatments to improve its effectiveness.
Platinum-based doublet chemotherapy
refers to a combination of two chemotherapy drugs that include a platinum-containing compound. These drugs work together to stop the growth of cancer cells by damaging their DNA, which prevents them from dividing and growing. This type of chemotherapy is commonly used to treat various types of lung cancer.
Canakinumab
is an investigational medication being studied in this trial to see if it can enhance the effects of pembrolizumab and chemotherapy. It is thought to work by reducing inflammation in the body, which may help slow down the growth of cancer cells. The trial is testing whether adding canakinumab to the treatment regimen can improve outcomes for patients with lung cancer.

What is already known about the treatment

Pembrolizumab
This medication is administered intravenously and is currently used in clinical trials for treating non-small cell lung cancer. It is a well-established drug in medical literature, primarily used for its immune-boosting properties. Pembrolizumab works by blocking a specific protein on cancer cells, allowing the immune system to better detect and attack these cells. It is classified as an immune checkpoint inhibitor.
Canakinumab
This medication is also administered intravenously and is being studied in combination with pembrolizumab and chemotherapy for non-small cell lung cancer. It is still under investigation in clinical trials, with limited use in current medical practice. Canakinumab targets and neutralizes a specific protein involved in inflammation, potentially reducing cancer-related inflammation. It is classified as an interleukin-1 beta inhibitor.

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 shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. Early stages may not show noticeable symptoms, making it challenging to detect without medical screening.