A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
This research study is looking at a new treatment called alectinib for a specific type of lung cancer known as ALK-positive non-small cell lung cancer. This cancer has often been completely removed by surgery. The study aims to compare alectinib to the usual chemotherapy treatments given after surgery. Participants will either receive alectinib pills twice a day for two years, or a course of standard chemotherapy over several months. Doctors will then observe all patients closely to see if the cancer returns. The main goal is to find out if alectinib is more effective at preventing the cancer from coming back and if it has fewer side effects than current treatments. This could potentially offer a new, more targeted treatment option for people with this condition.
At a glance
What is this study about?
This study is designed for individuals who have undergone surgery to remove a specific type of lung cancer called ALK-positive non-small cell lung cancer. This particular type of lung cancer has a unique change in its genes (called ALK-positive), which means that certain targeted treatments might work well.
After surgery, doctors often give additional treatments to try and stop any remaining cancer cells from growing back. This is called 'adjuvant therapy.' Currently, chemotherapy is a standard adjuvant treatment for many lung cancers. However, this study is investigating whether a newer drug, alectinib, could be a better option for people with ALK-positive non-small cell lung cancer.
Alectinib is a targeted drug, meaning it's designed to attack cancer cells that have the specific ALK gene change, potentially leaving healthy cells mostly unharmed. By comparing alectinib to traditional chemotherapy, researchers hope to discover if alectinib is more effective at preventing the cancer's return and if it has a more manageable side effect profile. The findings from this study could lead to improved treatments for this condition in the future.
Key takeaways
- The study compares alectinib (a new pill) to standard chemotherapy for ALK-positive lung cancer.
- Treatment is given after surgery to try and stop the cancer from returning.
- You will either take alectinib for two years or receive several cycles of chemotherapy.
- Regular check-ups and follow-up will monitor your health and cancer status.
- The goal is to find a more effective and safer treatment to prevent cancer recurrence.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be at least 18 years old and have had surgery to completely remove a specific type of lung cancer called ALK-positive non-small cell lung cancer. This surgery must have happened within the last 4 to 12 weeks. Your cancer needs to be in certain stages (Stage 1B to 3A) and confirmed to be 'ALK-positive' using a special test.
You also need to be generally well enough to receive standard chemotherapy, as assessed by your doctor. Your blood tests, especially those checking your kidneys, need to be healthy enough for treatment. If you are a woman who could become pregnant, or a man, you must agree to use reliable contraception during the study and for a period afterwards to prevent pregnancy.
There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or plan to become pregnant soon, you cannot participate. If you've had radiation therapy to your chest for lung cancer before, or if you've already received other ALK-targeting drugs or cancer treatments, you would not be eligible. Also, if your doctor believes you need radiation therapy after surgery, you might not be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am at least 18 years old.
- I have had surgery for ALK-positive non-small cell lung cancer within the last 4-12 weeks.
- My doctors consider me well enough for standard chemotherapy.
- I have not had previous radiation to my chest for lung cancer or other cancer treatments.
- I am not pregnant or breastfeeding, and I agree to use effective contraception if needed.
- I am willing and able to attend all study visits and complete tests.
What does participation involve?
If you decide to participate, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the study drug, alectinib, which is taken as pills, two tablets twice a day with food for two years. The other group will receive standard chemotherapy, which involves several cycles of treatment. The specific chemotherapy drugs used will depend on what your doctors normally prescribe.
Throughout the study, you will have regular visits to the hospital for checks, blood tests, and scans to see how you are doing and to monitor for any side effects. After your main treatment finishes, either after two years for alectinib or after your chemotherapy cycles, doctors will continue to follow your health closely to see if your cancer ever returns. If your cancer does come back, you will then enter a longer follow-up period to track your survival. The study will continue until either you decide to leave, the study finishes, or unfortunately, if you pass away.
Potential risks and benefits
Locations (114)
- Rush University Medical CenterVerified postcodeChicago, United States
- MGH Cancer CenterVerified postcodeBoston, United States
- AHN Cancer Institute ? Allegheny General HospitalVerified postcodePittsburgh, United States
- Chris O'Brien LifehouseVerified postcodeCamperdown, Australia
- GenesisCare North ShoreVerified postcodeSt Leonards, Australia
- Peter MacCallum Cancer CenterVerified postcodeMelbourne, Australia
- Krankenhaus Nord - Klinik FloridsdorfVerified postcodeVienna, Austria
- Healthcare Institution Grodno University HospitalVerified postcodeHrodna, Belarus
- Healthcare Institution ?Gomel Regional Clinical Oncologic Dispensary?Verified postcodeHomyel, Belarus
- Vitebsk Regional Clinical Oncology DispensaryVerified postcodeVitebsk, Belarus
- Clinical center University of SarajevoVerified postcodeSarajevo, Bosnia and Herzegovina
- Beijing Cancer HospitalVerified postcodeBeijing, China
Common questions
What is ALK-positive lung cancer?
It's a specific type of lung cancer where the cancer cells have a particular gene change called ALK, which helps them grow.
What does 'adjuvant setting' mean?
It means the treatment is given after the main treatment (like surgery) to try and prevent the cancer from coming back.
What is the difference between chemotherapy and alectinib?
Chemotherapy uses strong drugs to kill fast-growing cells, including cancer cells. Alectinib is a 'targeted' drug that specifically attacks cancer cells with the ALK gene change, aiming for fewer side effects.
How long will I take the study drug?
If you receive alectinib, you will take pills twice a day with food for two years. If you receive chemotherapy, it will be for 4 cycles.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, so both you and your doctor will know whether you are receiving alectinib or chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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