Study on Alectinib for Patients with ALK+ Stage III 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 known as Non-Small Cell Lung Cancer (NSCLC) that is locally advanced and positive for a specific mutation called anaplastic lymphoma kinase (ALK+). The treatment being tested is a medication called Alectinib, which is taken orally in the form of a capsule. The purpose of the study is to evaluate how effective and safe Alectinib is when used before surgery to shrink the tumor in patients with this type of lung cancer.

Participants in the study will receive Alectinib as a single treatment, meaning no other cancer treatments will be given alongside it. The study will observe how the cancer responds to the medication and will also monitor the safety of the treatment. The trial is designed to be open-label, which means both the researchers and participants will know that Alectinib is being administered. The study will take place across multiple centers, allowing for a broader collection of data.

The trial will continue until the planned end date, with regular assessments to check the cancer’s response to the treatment. The main goal is to see if the cancer shows a significant reduction in viable tumor cells after treatment with Alectinib and before surgical removal. This study aims to provide valuable information on the potential benefits of using Alectinib as a pre-surgery treatment option for patients with ALK+ NSCLC.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study and understand that you can withdraw at any time without affecting your future medical care.

2 initial assessments

You will undergo several initial assessments to confirm eligibility. These include a review of your medical history, a physical examination, and various tests such as blood tests and imaging scans like CT or MRI to ensure you meet the study criteria.

3 medication administration

You will begin taking the study medication, alectinib, which is administered orally. The specific dosage and frequency will be provided by the study team, and you will be required to take the medication as instructed for the duration of the study.

4 regular monitoring

Throughout the study, you will have regular appointments for monitoring. These appointments will include physical exams, blood tests, and imaging scans to assess your response to the medication and monitor for any side effects.

5 surgery preparation

If the medication is effective and your condition is suitable, you will be prepared for surgery to remove the lung cancer. This will involve discussions with your medical team and additional tests to ensure you are ready for the procedure.

6 surgery

You will undergo surgery to remove the lung cancer. The surgical team will provide detailed information about the procedure and what to expect during recovery.

7 post-surgery follow-up

After surgery, you will have follow-up appointments to monitor your recovery and assess the effectiveness of the treatment. This will include physical exams and possibly additional imaging tests.

8 end of study participation

Your participation in the study will conclude after the final follow-up assessments. The study team will provide information on any further steps or treatments that may be necessary.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means you should be fully active or have some symptoms but still able to carry out light work.
Must be able to swallow oral medications.
Must have adequate blood function, which means having enough white blood cells, platelets, and hemoglobin in your blood.
Must have adequate liver function, meaning your liver tests should be within a certain range.
Must have adequate kidney function, meaning your kidney tests should be within a certain range.
Must have a stable medical condition, meaning no serious infections or major surgeries in the last 4 weeks.
Female patients who can have children must use effective birth control and not be breastfeeding. They must also have a negative pregnancy test before starting the study.
Male patients with a female partner who can have children must use effective birth control or have had a vasectomy.
Must be able to follow the study requirements.
Must have a confirmed diagnosis of adenocarcinoma of the lung, which is a type of lung cancer.
Must be able to provide written informed consent, meaning you agree to participate in the study after understanding all the details.
Must have ALK positive disease, confirmed by specific tests.
Must have locally advanced stage III NSCLC, which means the cancer is in a specific stage and location in the lung.
Must be a candidate for surgical removal of lung cancer after a discussion with a team of doctors.
Must not have received any previous treatment for NSCLC and be eligible to receive Alectinib, the study medication.
Must have measurable disease as defined by specific criteria using a CT scan.
Must have a brain MRI or CT scan showing no signs of cancer spread to the brain.
Must have a PET CT scan showing stage III lung cancer.

Who Cannot Join the Study?

Patients who do not have a diagnosis of anaplastic lymphoma kinase positive (ALK+) locally advanced Stage III Non-Small Cell Lung Cancer (NSCLC).
Patients whose cancer is not potentially resectable, meaning it cannot be surgically removed.
Patients who are not in the age range specified for the study.
Patients who are not willing or able to comply with the study requirements.
Patients who have other medical conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or adverse reactions to the study medication.
Patients who have a history of certain other cancers.
Patients who have serious infections or other serious health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
San Camillo Forlanini Hospital	Rome	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Aknhubd Oddrnqkvjet Uitgpfcmkrumu Ppdxe	Parma	Italy
Ispxew Iuxmhwkz Fojigakykevrt Opnilazhjwa	Rome	Italy
Avacewo Ujv Tmbvytr nqjw olpgo	Leghorn	Italy
Izegbhpp Rljgzkkpo Pwq Lx Shphta Dqw Ttzwnf Dvnx Abcslan Iilv Scehuj	Meldola	Italy
Axcbbje Uirem Sxatibprs Lgwwjy Da Byefkxq	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	31.05.2021

Trial locations

Investigated drugs:

Alectinib

Alectinib is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as ALK-positive non-small cell lung cancer (NSCLC). This medication works by targeting and blocking the activity of a protein produced by the cancer cells, which is responsible for their growth and spread. By inhibiting this protein, Alectinib helps to slow down or stop the progression of the cancer, making it easier to manage and potentially shrink the tumors before surgery. This trial is focused on using Alectinib as a treatment before surgery to see how effective it is in reducing the cancer’s size and improving surgical outcomes.

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It generally starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease progresses through stages, with Stage III indicating locally advanced cancer that may have spread to nearby tissues or lymph nodes but not to distant body parts. Symptoms can include a persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and other systemic symptoms. The progression of NSCLC can vary significantly depending on the specific subtype and individual patient factors.

Trial ID:

2024-519106-12-00

Protocol code:

ALNEO trial-GOIRC-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Alectinib for Patients with ALK+ Stage III Non-Small Cell Lung Cancer

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