Study Comparing Lorlatinib and Crizotinib for Patients with Advanced ALK-Positive Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a specific type of lung cancer known as advanced ALK-positive non-small cell lung cancer. The study is comparing two treatments: lorlatinib, which is also known by its code name PF-06463922, and crizotinib. Both of these are medications taken in tablet form. The purpose of the study is to determine if lorlatinib is more effective than crizotinib in delaying the progression of this type of lung cancer.

Participants in the study will be randomly assigned to receive either lorlatinib or crizotinib as their treatment. The study will monitor the participants over a period to see how the cancer responds to the treatment. This will help researchers understand which medication might be better at controlling the disease. Some participants will receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

The study aims to provide valuable information about the effectiveness and safety of these treatments for patients who have not received prior treatment for their advanced lung cancer. By participating, individuals contribute to research that could improve future treatment options for this type of cancer. The study is expected to continue until the end of 2028.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives lorlatinib and the other receives crizotinib. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

2 treatment administration

Participants in the lorlatinib group take the medication orally. The specific dosage and frequency are determined by the study protocol and are communicated to participants by the study team.

Participants in the crizotinib group also take their medication orally, with the dosage and frequency similarly specified by the study protocol.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes physical examinations, blood tests, and imaging studies such as CT or MRI scans.

Participants are also monitored for any side effects or adverse reactions to the medication. This information is collected to ensure participant safety and to evaluate the treatment’s impact on the disease.

4 progression-free survival evaluation

The primary goal of the study is to determine if lorlatinib is more effective than crizotinib in delaying the progression of the disease. This is measured by the time during which the disease does not worsen, known as progression-free survival (PFS).

Evaluations are conducted by an independent review to ensure unbiased results.

5 study completion

The study is expected to continue until December 31, 2028. Participants remain in the study until they complete the treatment protocol or until the study ends.

Upon completion, participants may receive information about the overall study results and their individual treatment outcomes.

Who Can Join the Study?

Patients must have a confirmed diagnosis of advanced ALK positive non-small cell lung cancer. This means the cancer has a specific genetic change called ALK, and it is in an advanced stage.
Patients must have at least one measurable tumor outside the brain that has not been treated with radiation before.
Patients can have cancer that has spread to the brain if it is not causing symptoms or if it has been treated and they have recovered.
Patients must provide a tissue sample from their tumor for testing. If a previous sample is not available, a new biopsy must be done.
Female patients who can have children must have a negative pregnancy test before starting the study.
Female patients who cannot have children must meet certain criteria, such as being postmenopausal or having had surgery to remove reproductive organs.
Patients must sign a consent form to show they understand the study and agree to participate.
Patients must be willing and able to attend scheduled visits and follow the study procedures.
Patients must not have received any previous treatment for advanced lung cancer, including specific drugs targeting ALK, chemotherapy, or immunotherapy.
Patients must have a performance status of 0, 1, or 2, which means they are able to carry out daily activities with varying degrees of assistance.
Patients must be at least 18 years old (or 20 years old if required by local regulations).
Patients must have adequate bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin.
Patients must have adequate pancreatic function, meaning certain enzyme levels in the blood must be within normal limits.
Patients must have adequate kidney function, which involves having normal levels of creatinine in the blood or a certain level of kidney filtration.
Patients must have adequate liver function, with specific liver enzyme levels within normal limits.
Any side effects from previous radiation therapy must have resolved to a mild level or to the level they were before treatment, unless the doctor believes they are not a safety risk.

Who Cannot Join the Study?

Patients who have previously received treatment for their lung cancer.
Patients with other types of cancer that are not under control.
Patients with serious heart problems.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar medications.
Patients with severe liver or kidney problems.
Patients who are unable to follow the study procedures.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
San Camillo Forlanini Hospital	Rome	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Grand Hopital De Charleroi	Charleroi	Belgium
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Med Polonia Sp. z o.o.	Poznan	Poland
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Teresa Herrera C.H.U.A.C.	A Coruna Galicia	Spain
Irqwtz Ivgskryi Fgyezzephmxgn Oktaaisjaip	Rome	Italy
Usgqxoljbcfp Mwqkpvo Ctpcbtb Gsskavdtg	Groningen	The Netherlands
Mhyi Ccvpwhg Mpejiwjy Svcfkchd	Szczecin	Poland
Awjtsvoerh Pbcqrhbh Hmwailrn De Mzxvfznuy	Marseille	France
Ntdvetqd Ifdrvgnq Otwvflhnb Iux Mghcb Sgqnwcgmdnqcvhotmkppsqnxoedf Ichaewkg Biyttojy	Cracow	Poland
Uvakwmotmksrso Cyoojep Kdaicrfey	Gdansk	Poland
Ifphbbmy Csemdq Dllpotbqybenwndms	L'hospitalet De Llobregat	Spain
Hhjojyjq Vfhj ddvdtsdl	Barcelona	Spain
Iluvkhje Pjmqdflxrvzsdhz Ciseaw Cjnagg	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.10.2017
Czechia	Not recruiting	16.10.2017
France	Not recruiting	16.10.2017
Germany	Not recruiting	16.10.2017
Italy	Not recruiting	16.10.2017
Poland	Not recruiting	16.10.2017
Spain	Not recruiting	16.10.2017
The Netherlands	Not recruiting	16.10.2017

Trial locations

Investigated drugs:

Lorlatinib

Lorlatinib is a medication used in this clinical trial as a single treatment option for patients with advanced ALK-positive non-small cell lung cancer (NSCLC). It is being tested to see if it can help patients live longer without their cancer getting worse compared to another treatment.

Crizotinib is another medication used in this trial as a single treatment for the same type of lung cancer. It is being compared to lorlatinib to determine which medication is more effective in delaying the progression of the disease in patients who have not received prior treatment.

Advanced ALK Positive Non-Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as ALK (anaplastic lymphoma kinase) gene rearrangement. It primarily affects non-small cell lung cancer (NSCLC) patients, which is the most common type of lung cancer. The disease progresses as cancer cells grow and spread in the lungs and potentially to other parts of the body. Patients with this condition may experience symptoms such as persistent cough, chest pain, and difficulty breathing. The presence of the ALK gene rearrangement can influence the behavior of the cancer and its response to certain treatments.

Trial ID:

2023-509169-19-00

Protocol code:

B7461006

NCT ID:

NCT03052608

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Lorlatinib and Crizotinib for Patients with Advanced ALK-Positive Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

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