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Study on Osimertinib for Patients with Stage III Unresectable Non-Small Cell Lung Cancer After Chemoradiation Therapy

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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 known as Non-Small Cell Lung Cancer (NSCLC), specifically in patients whose cancer is locally advanced and cannot be removed by surgery. The study is looking at patients with a specific genetic change in their cancer called an EGFR mutation. The treatment being tested is a medication called Osimertinib, which is also known by its code name AZD9291. This medication is being compared to a placebo to see if it can help prevent the cancer from getting worse after patients have already received a combination of chemotherapy and radiation therapy.

The purpose of the study is to see how effective Osimertinib is in keeping the cancer from progressing. Participants in the study will be randomly assigned to receive either Osimertinib or a placebo. The study is designed to be "double-blind," which means neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The medication is taken orally in the form of film-coated tablets.

Throughout the study, participants will be monitored regularly to check on their health and to see how the cancer is responding to the treatment. This will involve various assessments, including physical exams and possibly imaging tests. The study aims to provide valuable information on whether Osimertinib can be an effective maintenance therapy for patients with this type of lung cancer, potentially improving their quality of life and extending the time before the cancer progresses.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including age, type of lung cancer, and previous treatment with chemoradiation.
The study focuses on patients with a specific type of lung cancer that has not progressed after initial treatment.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Medication administration
Participants take the assigned medication orally. The options include osimertinib in doses of 40 mg or 80 mg, or a placebo.
The medication is taken in the form of film-coated tablets.
Step 4
Treatment duration
The treatment continues until the disease progresses or unacceptable side effects occur. The study aims to assess the effectiveness of the medication in delaying disease progression.
Step 5
Monitoring and assessments
Regular assessments are conducted to monitor the disease status and any side effects. These include physical exams, blood tests, and imaging studies.
Quality of life is also evaluated using specific questionnaires.
Step 6
End of study participation
Participation concludes when the study ends or if the disease progresses. Participants may also choose to withdraw at any time.
The estimated end date for the study is June 29, 2026.

Who can join the trial?

9 criteria

Must be a male or female aged at least 18 years.
Must have a type of lung cancer called **non-small cell lung cancer** (NSCLC) that is mostly non-squamous and is at a stage called **locally advanced, unresectable (Stage III)**.
The tumor must have specific changes in a gene called **EGFR**. These changes are known as **Ex19del** or **L858R** mutations, which can be alone or with other EGFR mutations. These must be confirmed by specific tests.
Must have received a treatment called **chemoradiation**, which includes at least 2 cycles of a type of chemotherapy called **platinum-based chemotherapy** and a specific amount of radiation.
The chemoradiation treatment must have been completed no more than 6 weeks before joining the study.
The disease must not have gotten worse during or after the chemoradiation treatment.
Must have a **World Health Organization (WHO) performance status** of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have a life expectancy of more than 12 weeks from the start of the study.
Female patients who are not abstinent must use adequate birth control, must not be breastfeeding, and must have a negative pregnancy test before starting the study drug. Alternatively, they must be unable to have children.

Who cannot join the trial?

4 criteria

Patients who have a different type of lung cancer than the one specified in the study.
Patients whose lung cancer has progressed after receiving a specific type of treatment called **platinum-based chemoradiation**. This is a combination of chemotherapy and radiation therapy.
Patients who do not have the specific **EGFR mutations** required for the study. EGFR mutations are changes in a gene that can affect how cancer grows.
Patients who have a type of lung cancer that can be surgically removed.

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Verified sites

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

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Hospital Del Mar
Barcelona, Spain
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
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Hospital Universitario Y Politecnico La Fe
Valencia, Spain

Trial locations

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Investigated drugs

Osimertinib is a medication used in this clinical trial as a maintenance therapy for patients with a specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has a mutation in the EGFR gene. The trial is investigating how effective osimertinib is in preventing the cancer from getting worse after patients have already received a combination of chemotherapy and radiation therapy.

What is already known about the treatment

Osimertinib – Osimertinib is administered orally in tablet form. It is currently being studied in clinical trials as a maintenance therapy for patients with non-small cell lung cancer that has specific genetic mutations and has not progressed after initial treatment. The main therapeutic indication is for non-small cell lung cancer with EGFR mutations. At the molecular level, osimertinib works by inhibiting the activity of the epidermal growth factor receptor (EGFR) with specific mutations, which helps to slow down or stop the growth of cancer cells. It is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, primarily adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, leading to the formation of tumors. NSCLC is often diagnosed at an advanced stage, where the cancer has spread locally or to other parts of the body. The disease progresses as the cancer cells continue to grow and invade nearby tissues or spread to distant organs. Specific genetic mutations, such as EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, can influence the behavior and progression of the cancer. These mutations may also affect how the cancer responds to certain treatments.