Study of Alectinib and Platinum-Based Chemotherapy for Patients with Resected Stage Ib to IIIa ALK-Positive Non-Small Cell Lung Cancer

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What is this study about?

The study focuses on patients with a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically when this cancer has a certain genetic marker called ALK-positive. The stages of cancer involved range from Stage Ib, with tumors at least 4 centimeters, to Stage IIIa. This trial looks at how well two different treatments work after the cancer has been surgically removed: a drug named Alectinib and a group of drugs known as platinum-based chemotherapy.

Alectinib is provided in capsule form and taken orally. It belongs to a group of drugs that target specific cancer cells with the ALK marker, aiming to stop their growth and spread. Platinum-based chemotherapy involves medications like Carboplatin, Cisplatin, and Pemetrexed, which are given through an infusion, meaning they are administered directly into the bloodstream. This form of chemotherapy uses drugs that contain the metal platinum, which helps to damage the DNA of cancer cells, preventing them from dividing and growing.

The purpose of this study is to compare how effectively these treatments prevent cancer from returning in patients who have already had their tumors removed. By looking at which treatment helps patients remain cancer-free for a longer period, the study aims to determine the better option for use after surgery in this specific type of lung cancer.

1 enrollment

Upon joining the study, confirmation of complete removal of the lung cancer is required. The cancer must be at Stage Ib (tumors 4 cm or larger) to Stage IIIa and must be positive for a specific protein called anaplastic lymphoma kinase (ALK).

Eligibility includes having a good performance status, adequate blood and kidney function, and the ability to follow the study schedule.

2 randomization

Participants are randomly assigned to one of two groups: one receiving alectinib and the other receiving platinum-based chemotherapy.

3 treatment with alectinib

If assigned to the alectinib group, take 150 mg hard capsules orally. The frequency and duration of administration will be specified by the study protocol.

4 treatment with platinum-based chemotherapy

If assigned to the chemotherapy group, receive one of the following medications through intravenous infusion: carboplatin, cisplatin, pemetrexed, gemcitabine hydrochloride, or vinorelbine. The specific medication, dosage, and schedule will be determined by the study protocol.

5 monitoring and assessments

Regular visits are required to monitor health status, including assessments of disease-free survival, overall survival, and any side effects.

Blood tests and other laboratory evaluations will be conducted to check for any abnormal findings.

Vital signs and heart function will be monitored through electrocardiograms.

6 completion

The study is expected to conclude by November 19, 2026. Final assessments will be conducted to evaluate the outcomes of the treatment.

Who Can Join the Study?

The patient must have had a complete removal of a lung tumor that was confirmed by a lab test to be Stage Ib (tumor size 4 cm or larger) to Stage IIIa, with no cancer cells left at the edges of the removed tissue. This surgery should have been done 4 to 12 weeks before joining the study.
The patient must have a documented ALK-positive disease, which means their cancer has a specific genetic change, confirmed by a test approved by health authorities.
The patient must be able to receive a platinum-based chemotherapy treatment, which is a type of cancer treatment, according to local medical guidelines.
The patient must have an Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
The patient must have adequate blood and kidney function, meaning their blood and kidneys are working well enough to participate in the study.
The patient must be willing and able to attend scheduled visits, follow treatment plans, and undergo lab tests and other study procedures.
The study is open to both male and female participants.

Who Cannot Join the Study?

Patients who have not had their lung cancer completely removed by surgery.
Patients with lung cancer that is not classified as Stage Ib (tumors 4 cm or larger) to Stage IIIa.
Patients whose lung cancer is not positive for Anaplastic Lymphoma Kinase (ALK). ALK is a specific gene that can be involved in the growth of cancer cells.
Patients who have not been diagnosed with Non-Small Cell Lung Cancer (NSCLC). NSCLC is a type of lung cancer that grows and spreads more slowly than small cell lung cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or its results.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had certain treatments for cancer recently, which might affect the study results.

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
Lungenfachklinik	Immenhausen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Franziskus Hospital Harderberg	Georgsmarienhütte	Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
San Camillo Forlanini Hospital	Rome	Italy
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Metropolitan Hospital	Athens	Greece
Txggzkbjvd Ckvzzc Hdjqsydp	Thessaloniki	Greece
Apopjfpjxr Ppctykes Hyipyjvb Do Mrrwdqilg	Marseille	France
Nabcbqxy Izdbfiky Ojnrkjfxz Ihu Mtywa Srjlmiokoqwxfuvasbmabaspzqut Idhvaduu Bizqcitc	Cracow	Poland
Utscyhocdclgvy Csuicxx Kukgqihrx	Gdansk	Poland
Hdebzwdj Dt Ly Ssafw Cnks I Skfa Pql	Barcelona	Spain
Cgmmdr Hmilssbefpp Rgztdspn Dpzogklayeatdc	Angers	France
Fnrlmvikh Pscv Li Igpvqehnyjgcs Bgbchyxvl Dnb Hmovhwxw Ulpqvmimelcho Ls Pxd	Madrid	Spain
Hktsttpb Uofpjrlzdxfcd Hxisbetb Tzeky y Paldml Irmasaya Ccxbff dzjrtknzyfhpphvgs (qfwk	Badalona	Spain
Hcgjedia Vcfx dlemoaah	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.11.2018
Denmark	Not recruiting	28.11.2018
France	Not recruiting	28.11.2018
Germany	Not recruiting	28.11.2018
Greece	Not recruiting	28.11.2018
Hungary	Not recruiting	28.11.2018
Italy	Not recruiting	28.11.2018
Poland	Not recruiting	28.11.2018
Romania	Not recruiting	28.11.2018
Spain	Not recruiting	28.11.2018

Trial locations

Investigated drugs:

Alectinib is a medication used in this trial to treat patients with a specific type of lung cancer known as ALK-positive non-small-cell lung cancer. It works by targeting and blocking the activity of a protein that helps cancer cells grow, which may help to stop or slow down the growth of the cancer.

Platinum-Based Chemotherapy is a standard treatment for various types of cancer, including lung cancer. It involves using drugs that contain the metal platinum to damage the DNA of cancer cells, which can prevent them from dividing and growing. This type of chemotherapy is often used after surgery to help eliminate any remaining cancer cells.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. In the case of ALK-positive NSCLC, a genetic mutation in the anaplastic lymphoma kinase (ALK) gene leads to cancer development. The disease progresses through stages, with Stage Ib indicating tumors that are 4 cm or larger, and Stage IIIa involving more extensive spread within the lung or to nearby lymph nodes. The progression of NSCLC can vary, with some tumors growing slowly and others more rapidly.

Trial ID:

2023-506861-76-00

Protocol code:

BO40336

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Alectinib and Platinum-Based Chemotherapy for Patients with Resected Stage Ib to IIIa ALK-Positive Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?