Recruiting

Study on Fexofenadine Hydrochloride and Immunotherapy for Patients 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 the effects of combining an H1-antihistamine treatment with immunotherapy in patients with advanced non-small cell lung cancer (NSCLC). The treatment being tested is a medication called fexofenadine hydrochloride, which is commonly known as Allegra. This medication is typically used to treat allergy symptoms, but in this study, it is being explored for its potential benefits in cancer treatment. The study will also involve the use of a medication called pembrolizumab, which is an immunotherapy drug that helps the immune system fight cancer cells.

The purpose of the study is to evaluate how well this combination of treatments works in improving the response to cancer therapy. Participants will receive the treatments over a period of time, and their health will be monitored to see how the cancer responds. The study will look at various outcomes, including how long patients live without the cancer getting worse and their overall survival. Additionally, the study will assess the safety and side effects of fexofenadine when used in this new way, as well as its impact on patients' quality of life, particularly their sleep patterns.

Throughout the study, participants will undergo regular check-ups and assessments to track their progress. The study aims to provide valuable insights into whether adding fexofenadine to standard cancer treatment can enhance the effectiveness of immunotherapy in treating advanced non-small cell lung cancer. The trial is expected to continue until August 2026, with recruitment starting in October 2024.

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, you will be required to provide written informed consent. This means you agree to participate after understanding the purpose and procedures of the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your medical history, ensuring you have advanced non-small cell lung cancer, and checking that you have not received previous systemic therapy for metastatic disease.
Step 3
Medication administration
You will receive a medication called Allegra 120 mg Filmtabletten, which contains fexofenadine hydrochloride. This is a film-coated tablet taken orally.
The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.
Step 4
Combination with immunotherapy
The study involves combining the medication with immunotherapy. You will receive pembrolizumab as part of your treatment, which is a standard therapy for your condition.
Step 5
Regular monitoring
Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes physical examinations, imaging tests, and laboratory tests.
Your healthcare provider will evaluate your progress according to specific criteria to determine the effectiveness of the treatment.
Step 6
Quality of life assessments
You will be asked to complete questionnaires to assess your quality of life, focusing on aspects such as sleep quality and symptoms related to lung cancer.
These assessments will help understand the impact of the treatment on your daily life.
Step 7
End of study
The study is expected to conclude by August 29, 2026. At the end of the study, a final assessment will be conducted to evaluate your overall response to the treatment.

Who can join the trial?

13 criteria

Ability to understand the purpose of the study and provide written consent.
Diagnosis of squamous or non-squamous NSCLC (a type of lung cancer).
Evidence of metastatic unresectable disease (cancer that has spread and cannot be removed by surgery).
Presence of measurable disease according to specific criteria used to assess tumors.
No previous systemic therapy (treatment affecting the entire body) for metastatic disease.
Plan to receive pembrolizumab monotherapy (a specific cancer treatment) as part of routine care.
History of treated, symptom-free CNS metastases (cancer spread to the brain) is allowed if certain conditions are met, such as no need for ongoing steroid treatment.
Age 18 years or older.
ECOG-PS 0-2, KPS >70%: These are scales to measure general health and ability to perform daily activities.
Adequate bone marrow, liver, and kidney function, except if affected by the cancer.
Previous treatments like surgery, radiation, or chemotherapy are allowed if enough time has passed since the last treatment.
Ability to tolerate the therapy.
Women who can become pregnant must have a negative pregnancy test before starting the study and use approved birth control methods during the study.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides advanced non-small cell lung cancer cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with severe heart problems cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who have had a major surgery within the last 4 weeks cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with known allergies to the study medication cannot participate.
Patients with a history of drug or alcohol abuse within the last 2 years cannot participate.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

H1-antihistamine
is a type of medication that is commonly used to relieve allergy symptoms such as sneezing, itching, and runny nose. In this clinical trial, it is being used in combination with another treatment to see if it can help improve the response to therapy in patients with advanced non-small cell lung cancer. The goal is to see if adding this medication can help the body respond better to the main cancer treatment.
Immunotherapy
is a treatment that helps the body's own immune system fight cancer. It works by boosting the natural defenses of the body to recognize and attack cancer cells more effectively. In this trial, immunotherapy is being used alongside another medication to see if it can improve the treatment outcomes for patients with advanced non-small cell lung cancer. The aim is to enhance the body's ability to fight the cancer with the help of this therapy.

Fexofenadine Hydrochloride

What is already known about the treatment

H1-antihistamine – This medication is administered orally in the form of tablets or capsules and is currently being studied in combination with immunotherapy for treating advanced non-small cell lung cancer. In medical literature, H1-antihistamines are primarily known for their role in alleviating allergy symptoms, but this trial explores their potential in cancer treatment. The main therapeutic indication in this trial is to improve the response rate in lung cancer patients. At the molecular level, H1-antihistamines work by blocking histamine receptors, which may help modulate the immune response in cancer therapy. They are pharmacologically classified as antihistamines, commonly used to treat allergic reactions.

Investigated diseases

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the epithelial cells lining the lungs and is characterized by larger cell size compared to small cell lung cancer. It progresses by forming tumors that can grow and spread to other parts of the body, including the lymph nodes and distant organs. The disease often advances through stages, starting from localized tumors to more widespread metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing as the cancer grows. As it progresses, it can lead to complications such as pleural effusion and respiratory failure. The progression rate can vary, and it often requires ongoing monitoring to assess changes in tumor size and spread.