Study for Patients with Advanced Non-Small Cell Lung Cancer Worsened by Osimertinib Treatment, Using Selumetinib and Drug Combination

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that has progressed despite initial treatment. The study involves several medications, including Osimertinib, Selumetinib (also known as AZD6244), Datopotamab Deruxtecan, Durvalumab (also known as MEDI4736), Carboplatin, Etoposide, Cisplatin, and Infliximab. The purpose of the study is to evaluate how effective these treatments are in managing the disease.

Participants in the study will receive one of the treatments mentioned above, or a placebo, to see how their cancer responds. The study will monitor the participants’ health and the progression of their cancer over time. This will involve regular check-ups, imaging tests like MRI or CT scans, and blood tests to measure the levels of the drugs in the body. The study aims to understand which treatments work best for patients whose cancer has worsened after initial therapy with Osimertinib.

The trial will also assess the safety of these treatments by keeping track of any side effects or adverse reactions. This includes monitoring vital signs, conducting physical exams, and performing tests like Electrocardiograms (ECG) to check heart function. The study is expected to continue until May 2025, with recruitment starting in July 2024. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the effectiveness of the treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A biopsy is required to obtain a sample of the tumor. This procedure must be completed within 60 days before starting the study treatment.

2 treatment phase

The treatment phase involves the administration of specific medications. The primary medication used is osimertinib, taken orally as 80 mg film-coated tablets once daily.

If the disease progresses, additional medications may be introduced, such as selumetinib (oral capsules), datopotamab deruxtecan (infusion), durvalumab (IV infusion), and infliximab (infusion).

Other medications like carboplatin, etoposide, and cisplatin may be administered through IV infusion depending on the treatment plan.

3 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment. This includes imaging tests like CT or MRI to measure tumor size.

Blood tests and other laboratory evaluations are performed to monitor health and detect any side effects.

The response to treatment is evaluated using criteria known as RECIST 1.1, which helps determine the objective response rate.

4 follow-up

After completing the treatment phase, follow-up visits are scheduled to continue monitoring health and any long-term effects of the treatment.

These visits may include physical examinations, laboratory tests, and imaging studies to ensure ongoing health and well-being.

Who Can Join the Study?

The patient must have Advanced Non-Small Cell Lung Cancer (NSCLC), which means the cancer has spread and cannot be treated with surgery or radiation to cure it.
The patient must have a type of lung cancer called adenocarcinoma, which is confirmed by examining tissue or cells under a microscope. If the cancer has mixed types, adenocarcinoma should be the main type.
The patient must have a specific change in their cancer called an EGFR mutation, which makes the cancer sensitive to a type of treatment known as EGFR TKI.
The patient should have received only one type of treatment for advanced NSCLC, specifically a drug called osimertinib, and it should have been beneficial according to the doctor’s judgment.
The patient must show signs that the cancer has worsened after the first treatment with osimertinib.
The patient must be able to undergo a biopsy, which is a procedure to take a small sample of the tumor for testing. The tumor must be accessible, and the patient should be in a stable condition to handle the procedure.
The patient must have a tumor that can be measured accurately using scans like CT or MRI. The tumor should be at least 10 mm in size, except for lymph nodes, which should be at least 15 mm.
The patient must have normal blood clotting ability, which means certain blood tests should be within normal limits unless the patient is on medication that affects these tests.
The study is open to both male and female patients.
The study includes patients who are considered vulnerable, meaning they might need extra care or protection.

Who Cannot Join the Study?

Patients who have a different type of cancer than Advanced Non-Small Cell Lung Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
St. Olavs Hospital HF	Trondheim	Norway
Vestre Viken HF	Drammen	Norway
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Karolinska University Hospital	Solna	Sweden
Netherlands Cancer Institute	Amsterdam	The Netherlands
Avxehklfe Upx	Amsterdam	The Netherlands
Edemedz Unjmcjflcjcx Mhiksgt Cfqllyq Rcuuimuff (hlypwgq Moo	Rotterdam	The Netherlands
Hfxxbrva Dy La Sbhth Ctfv I Shrv Pxq	Barcelona	Spain
Famnwqvpw Phnv Lk Icrkzbdqrwnes Bbweywodt Dlw Hjycdcxb Uvtxpbpuihsns Lx Pnp	Madrid	Spain
Hduxmluc Uurjgqvtivqmq ds A Cvkkir	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	05.07.2024
Norway	Not recruiting	05.07.2024
Spain	Not recruiting	05.07.2024
Sweden	Not recruiting	05.07.2024
The Netherlands	Not recruiting	05.07.2024

Trial locations

Investigated drugs:

Osimertinib is a medication used in the treatment of non-small cell lung cancer. It works by targeting specific proteins in cancer cells, helping to slow down or stop their growth. In this trial, patients whose disease has progressed after initial treatment with osimertinib are being studied to see how they respond to new treatments.

Investigated diseases:

Non-small cell lung cancer

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by larger cell size compared to small cell lung cancer. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and spread to other parts of the body, often affecting the lymph nodes and other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and general health decline. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.

Trial ID:

2023-504624-25-00

Protocol code:

D6186C00001

NCT ID:

NCT03944772

Trial Phase:

Therapeutic exploratory (Phase II)

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Study for Patients with Advanced Non-Small Cell Lung Cancer Worsened by Osimertinib Treatment, Using Selumetinib and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?