Study on Osimertinib and Drug Combination for Adults with Unresectable Non-small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer called non-small cell lung cancer (NSCLC) that cannot be removed with surgery. The study is investigating the use of a medication called osimertinib, also known by its code name AZD9291. Osimertinib is being tested as a treatment given before and after chemotherapy and radiation therapy. The purpose of the study is to see if this approach is safe and effective for patients with this type of lung cancer.

Participants in the study will receive osimertinib as an initial treatment, known as induction therapy, before undergoing chemotherapy and radiation therapy. After these treatments, they will continue to take osimertinib as a maintenance therapy. The study will monitor the participants over a period of time to assess how well the treatment works and to check for any side effects. The study will also include a comparison with a placebo to evaluate the effectiveness of osimertinib.

The trial aims to gather information on how long patients live without their cancer getting worse, as well as other outcomes such as overall survival and response to treatment. The study will also look at the safety and tolerability of osimertinib by monitoring any adverse effects, changes in vital signs, and results from laboratory tests. This information will help determine if osimertinib is a beneficial treatment option for patients with unresectable NSCLC.

1 induction therapy

The initial phase involves taking osimertinib as an induction therapy. This medication is administered orally in the form of film-coated tablets. The dosage is either 40 mg or 80 mg, depending on the specific requirements of the treatment plan.

This phase is designed to prepare the body for subsequent treatments and is crucial for assessing the initial response to the medication.

2 chemotherapy and radiation therapy

Following the induction therapy, a combination of chemotherapy and radiation therapy is administered. This phase is known as CRT (chemoradiotherapy).

Chemotherapy involves the use of medications such as carboplatin, pemetrexed, cisplatin, and paclitaxel. These are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual patient needs and response to treatment.

3 maintenance therapy

After completing the chemoradiotherapy phase, osimertinib is used again as a maintenance therapy. This involves continuing the oral administration of the medication to help maintain the effects achieved during the previous phases.

The goal of this phase is to prolong the period during which the disease does not progress and to manage any remaining cancer cells.

4 follow-up and monitoring

Throughout the trial, regular follow-up appointments are scheduled to monitor the patient’s health and response to the treatment. This includes assessments of vital signs, laboratory tests, and imaging studies such as CT or MRI scans.

The healthcare team will evaluate the effectiveness of the treatment and make any necessary adjustments to the therapy plan.

Who Can Join the Study?

Patients must be at least 18 years old or the legal age of consent in their area when signing the consent form.
Patients must have test results showing their tumor has specific changes in a gene called EGFR. These changes are linked to how the tumor responds to certain treatments.
Patients should have a WHO performance status of 0 or 1, meaning they are fully active or have some symptoms but can still do light work.
Patients should have a life expectancy of more than 12 weeks from the start of the study.
Patients must agree to participate in optional genetic research by signing a special consent form.
Patients must have at least one tumor that can be measured accurately using a CT or MRI scan.
Both males and females can participate. They must use birth control methods as required by local rules for clinical studies.
Patients must be able to give informed consent and follow the study’s rules.
Patients must have a specific type of lung cancer called NSCLC that cannot be removed by surgery and is at an advanced stage.
Patients should be planning to receive a combination of chemotherapy and radiation therapy.
Patients who had surgery for earlier stages of cancer can join if they haven’t had other treatments like chemotherapy or radiation.
Patients with HBV (a liver infection) can join if they meet certain conditions, such as having low virus levels and receiving treatment.
Patients with HIV can join if they have no other infections, have a low virus level, and have a stable health condition.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
Patients who have serious heart problems, such as a recent heart attack or heart failure.
Patients who have an active infection that requires treatment with antibiotics.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or similar drugs.
Patients who have had a major surgery within the last 4 weeks.
Patients who are currently participating in another clinical trial.
Patients who have a condition that affects their ability to take the study medication as directed.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who have a serious mental health condition that is not well controlled.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hkmgksyp Unmjpzhroujxd Dnvopthg	Donostia / San Sebastian	Spain
Inmosuvg Cmahrc Dnbtkkxvuthzhlpcr	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Osimertinib is a medication used in this clinical trial for patients with a specific type of lung cancer that cannot be removed by surgery. It targets and blocks certain proteins that help cancer cells grow. In this study, osimertinib is given to patients before they receive other cancer treatments to help shrink the tumor. After the initial treatment, patients continue to take osimertinib to help keep the cancer from coming back or growing.

Investigated diseases:

Non-small cell lung cancer stage III

Unresectable Non-small Cell Lung Cancer – This is a type of lung cancer that cannot be removed through surgery due to its location, size, or spread to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and divide uncontrollably, forming tumors in the lungs. Over time, these tumors can invade nearby tissues and organs, and may spread to other parts of the body through the bloodstream or lymphatic system. Symptoms often include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary greatly among individuals, depending on factors such as the specific genetic mutations present in the cancer cells.

Trial ID:

2023-507798-16-00

Protocol code:

D516AC00003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Osimertinib and Drug Combination for Adults with Unresectable Non-small Cell Lung Cancer

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