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A Clinical Trial to Compare Alectinib Versus Chemotherapy After Surgery in Patients with ALK-Positive Non-Small Cell Lung Cancer (ALINA)
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- Non Small Cell Lung Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Countries
- Australia
- Austria
- Belarus
- Bosnia and Herzegovina
- China
- Denmark
- Egypt
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Japan
- Kazakhstan
- North Macedonia
- Poland
- Romania
- Russia
- South Korea
- Spain
- Taiwan
- Thailand
- Turkey
- Ukraine
- United Kingdom
- United States
Trial Identifier:
NCT03456076 2017-004331-37 BO40336
Trial Summary
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03456076,BO40336,2017-004331-37
Trial Identifier
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
How does the ALINA clinical trial work?
This clinical trial is recruiting people with a specific type of lung cancer called ‘non-small cell lung cancer’ or NSCLC that has been completely removed by recent surgery. The removed lung cancer must be positive for a change in a protein called ‘ALK ’ (this is called ‘ALK-positive NSCLC’).
How do I take part in this clinical trial?
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor.
If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor who will give you all the information you need to make your decision about taking part in the clinical trial. You will also find the clinical trial locations at the top of this page.
Before starting the clinical trial, you will be told about any risks and benefits of taking part and what other treatments are available so that you may decide if you still want to take part. While taking part in the clinical trial, both men and women (who are able to become pregnant) will need use effective contraceptive methods or not have heterosexual intercourse for safety reasons (pregnant women cannot participate).
You will have some further tests and procedures to make sure you are a suitable candidate for this clinical trial. Some of these tests and procedures may be part of your regular medical care and may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
What treatment will I be given if I join this clinical trial?
The aim of this trial is to compare the effects, good or bad, of alectinib versus chemotherapy, which is currently the most common treatment for NSCLC after complete removal of the tumour by surgery. The trial will be comparing alectinib with chemotherapy to find out which is better at stopping the cancer from coming back after a complete removal by surgery.
Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given one of the two different treatments:
- Either you will be given 4 capsules of alectinib to swallow 2 times a day for 2 years.
- Or you will be given 4 intravenous infusions of chemotherapy (the drug is slowly injected into your vein) once every 3 weeks for a total duration of 12 weeks.
How often will I be seen in follow-up appointments, and for how long?
If you take part in this clinical trial, whichever treatment you are given, you could have up to 18 visits over the first 2 years to the clinical trial site for treatment, safety monitoring, and monitoring of your disease. Afterwards, you will have regular check-ups to monitor your disease every 24 weeks during years 3 to 5, and every year thereafter. Visits may last about 2-6 hours depending on the tests performed each time.
What happens if I’m unable to take part in this clinical trial?
If your specific cancer type does not match what this clinical trial is looking at and/or the results of your blood tests or any other tests are not in the range needed for the trial, you will not be able to take part in this clinical trial. Your doctor will suggest other treatments for your cancer that you can be given or other clinical trials that you may be able to take part in. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on this page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT03456076
Trial Summary
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03456076,BO40336,2017-004331-37
Trial Identifier
Alectnib, Cisplatin, Vinorelbine, Gemcitabine, Pemetrexed, Carboplatin
Treatments
Carcinoma, Non-Small-Cell Lung
Condition
Official Title
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
Eligibility Criteria
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Age ≥18 years
- Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 weeks before enrollment
- If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred
- Documented ALK-positive disease according to an FDA-approved and CE-marked test
- Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
- Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
- Adequate hematologic and renal function
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm for at least 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy. Men must refrain from donating sperm during this same period
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- Prior adjuvant radiotherapy for NSCLC
- Prior exposure to systemic anti-cancer therapy and ALK inhibitors
- Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
- Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
- Malignancies other than NSCLC within 5 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in situ, papillary thyroid cancer, or any cured cancer that is considered to have no impact on disease free survival or overall survival for the current NSCLC
- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 × upper limit of normal or impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
- Japanese patients participating in the serial/intensive PK sample collection only: administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib up to Week 3
- Any exclusion criteria based on the local labels or guidelines for chemotherapy regimen
- Patients with symptomatic bradycardia
- History of organ transplant
- Known HIV positivity or AIDS-related illness
- Any clinically significant concomitant disease or condition that could interfere with-or for which the treatment might interfere with the conduct of the study or the absorption of oral medications or that would pose an unacceptable risk to the patients in this study, in the opinion of the Principal Investigator
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
For the latest version of this information please go to www.forpatients.roche.com