Study on Modified Osimertinib Dosing with Cobicistat for Advanced Non-Small Cell Lung Cancer in Patients with EGFR Mutation

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What is this study about?

This clinical trial is focused on improving the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a specific genetic change known as the EGFR driver mutation. The study is exploring the use of a medication called osimertinib, which is commonly used to treat this type of lung cancer. In some cases, another medication called cobicistat (also known by its code name GS-9350) may be used alongside osimertinib to enhance its effectiveness. The purpose of the study is to find a more cost-effective way to use osimertinib while maintaining its benefits and reducing side effects.

The study is divided into two parts. In the first part, patients with stable disease will receive a modified dose of osimertinib, with the aim of finding the best dose that is both effective and less toxic. This involves monitoring the drug levels in the body to ensure they stay within a safe and effective range. In the second part, patients with a specific type of brain progression, known as CNS oligoprogression, will receive standard osimertinib treatment, possibly with the addition of cobicistat, to see if this combination can better control the disease in the brain.

Throughout the study, patients will take the medications in the form of film-coated tablets, which are taken by mouth. The study will monitor how well the treatment works and any side effects that may occur. The goal is to provide a personalized treatment plan that is both effective and affordable for patients with advanced NSCLC.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, performance status, and current treatment with osimertinib 80 mg once daily.

Informed consent is required, and additional blood sampling for therapeutic drug monitoring and genetic analysis is necessary.

2 sub-study assignment

Participants are assigned to one of two sub-studies based on their disease status.

OSIBOOST 2-A: For patients with stable disease or better, focusing on a modified dosing strategy to improve cost-effectiveness and reduce side effects.

OSIBOOST 2-B: For patients with asymptomatic central nervous system progression, exploring pharmacokinetic boosting as a treatment option.

3 treatment administration

In OSIBOOST 2-A, osimertinib dosing is adjusted based on therapeutic drug monitoring to maintain effective drug levels while minimizing dosage.

In OSIBOOST 2-B, standard osimertinib treatment is boosted with cobicistat to enhance drug effectiveness in controlling central nervous system disease.

4 monitoring and evaluation

Regular monitoring of drug levels in the blood and cerebrospinal fluid is conducted to ensure therapeutic effectiveness.

The study evaluates the control of disease progression and any side effects experienced during the trial.

5 completion of the study

The study is expected to conclude by June 2026, with ongoing assessments of treatment outcomes and side effects throughout the trial period.

Who Can Join the Study?

The patient is currently taking osimertinib 80 mg once a day as part of their regular treatment.
The patient has a World Health Organisation (WHO) Performance Status of 0-2, which means they are able to carry out daily activities with little or no help.
The patient is 18 years old or older.
The patient is able and willing to sign a form that shows they understand and agree to participate in the study.
The patient is able and willing to have extra blood samples taken for monitoring the drug levels in their body.
The patient agrees to have their blood tested for a specific genetic type called CYP3A-genotype.
For OSIBOOST 2-A: The patient has a type of lung cancer called non-squamous advanced EGFR-mutated NSCLC and shows no signs of the disease getting worse, as confirmed by a CT scan. If there are signs of the disease getting worse, the patient can still join if their doctor thinks continuing treatment is suitable.
For OSIBOOST 2-B: The patient has non-squamous EGFR-mutated NSCLC with confirmed progression in the brain that does not cause symptoms and is not in a critical area. The disease outside the brain should be under control, with no signs of getting worse according to specific criteria.

Who Cannot Join the Study?

Patients who do not have Non-Small Cell Lung Cancer with an EGFR driver mutation. This means the cancer must have a specific change in the EGFR gene.
Patients who are not in the age range specified for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might need special protection or care.
Patients who do not meet the specific health conditions required for the study. This includes having advanced cancer with the specific mutation.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Ebmmbnc Uodzqqrdjusa Mznkjee Coveens Rjyeqhnya (yascybq Mxe	Rotterdam	The Netherlands
Ufaymvdtwfdt Mvxgsua Cfybcre Gypqsnukd	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Osimertinib is a medication used in the treatment of advanced Non-Small Cell Lung Cancer (NSCLC) with specific genetic mutations. In this clinical trial, the study aims to explore a modified dosing strategy for osimertinib to improve its cost-effectiveness and reduce side effects while maintaining its effectiveness. The trial involves monitoring the drug levels in the body and adjusting the dose accordingly to ensure it stays within a therapeutic range.

Cobicistat is used in this trial as a pharmacokinetic booster. Its role is to enhance the effectiveness of osimertinib by increasing its concentration in the body. This approach is being tested to see if it can help control cancer progression in the central nervous system without needing to increase the osimertinib dose, which can be costly and may not be covered by insurance.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer with an EGFR Driver Mutation – This is a type of lung cancer characterized by the presence of mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, and the presence of EGFR mutations can influence the behavior of the cancer and its response to certain treatments. The disease typically progresses through stages, starting from localized tumors to more advanced stages where cancer cells may spread to other parts of the body. Symptoms can include persistent cough, chest pain, and difficulty breathing, although they may vary depending on the stage and location of the cancer.

Trial ID:

2023-505700-35-00

NCT ID:

NCT05748093

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Modified Osimertinib Dosing with Cobicistat for Advanced Non-Small Cell Lung Cancer in Patients with EGFR Mutation

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