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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
21.12.2018
Spain Spain
Not recruiting
21.12.2018

Trial locations

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.

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.

Trial ID:
2024-511490-29-00
Protocol code:
CACZ885U2301
NCT ID:
NCT03631199
Trial Phase:
Therapeutic confirmatory (Phase III)

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