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Study on Osimertinib and Drug Combination for Adults with Unresectable 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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

13 criteria

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 trial?

10 criteria

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.

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Verified sites

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

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Hospital Del Mar
Barcelona, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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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.

What is already known about the treatment

Osimertinib – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating patients with unresectable non-small cell lung cancer that has specific mutations in the epidermal growth factor receptor (EGFR). Osimertinib works by targeting and inhibiting the activity of the EGFR, which is often overactive in certain types of cancer cells, leading to their growth and division. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

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.