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ALK Inhibitor
Alectinib vs Chemotherapy for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until death due to any cause up to approximately 8 years
Awards & highlights
Study Summary
This trial is investigating whether the drug alectinib is more effective than platinum-based chemotherapy in treating cancer, and is looking at the safety of both treatments. Participants will receive alectinib or platinum-based chemotherapy and then be followed up to see how their disease progresses.
Who is the study for?
This trial is for adults with ALK-positive Non-Small Cell Lung Cancer who've had surgery to remove the tumor and are eligible for chemotherapy. They must have good blood and kidney function, agree to use effective contraception, and be able to follow study procedures. Excluded are those with significant health issues that could affect the study, prior cancer treatments or organ transplants, pregnant or breastfeeding women, certain GI disorders affecting drug absorption, HIV/AIDS patients, and those unlikely to comply with protocol.Check my eligibility
What is being tested?
The trial compares alectinib—a targeted cancer drug taken orally twice daily for two years—with standard platinum-based chemotherapy given in four cycles. The goal is to see which treatment is more effective after lung cancer surgery in preventing disease recurrence. Participants will be randomly assigned to one of these treatments and followed up until disease recurrence or death.See study design
What are the potential side effects?
Alectinib may cause liver problems, muscle pain, constipation, swelling in parts of the body (edema), fatigue, low red blood cell count (anemia), changes in heart rhythm (bradycardia), among others. Platinum-based chemotherapies can lead to nausea/vomiting, hair loss (alopecia), kidney damage (nephrotoxicity), nerve damage (neuropathy) and bone marrow suppression leading to lower blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for platinum-based chemotherapy as per guidelines.
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I am fully active or can carry out light work.
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My cancer is ALK-positive based on an approved test.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of randomization until death due to any cause up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until death due to any cause up to approximately 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Secondary outcome measures
Overall Survival (OS)
Percentage of Participants with Adverse Advent
Plasma Concentration of Alectinib
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AlectinibExperimental Treatment1 Intervention
Group II: Platinum-Based ChemotherapyActive Control5 Interventions
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,797 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,245 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood and kidney functions are within normal ranges.I am willing and able to follow the study's schedule and procedures.I am fully active or can carry out light work.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have had an organ transplant.I agree to use effective birth control or remain abstinent during and for 90 days after treatment.I agree to use birth control and not donate sperm for 90 days after my last dose of treatment.I have had radiation therapy for lung cancer before it spread.I haven't had any cancer other than NSCLC in the last 5 years, except for certain treated early-stage cancers.I have a digestive condition that affects how my body absorbs pills.My liver is not functioning properly due to high enzyme levels or other serious conditions.I meet all requirements for chemotherapy according to local guidelines.My lung cancer was surgically removed with clear margins recently.My lymph nodes were checked for cancer spread without a mediastinoscopy.I am eligible for platinum-based chemotherapy as per guidelines.I am HIV positive or have an AIDS-related illness.I experience symptoms due to a very slow heartbeat.I have previously been treated with cancer drugs and ALK inhibitors.My cancer is ALK-positive based on an approved test.I do not have stage IIIA N2 cancer that requires post-operative radiotherapy.I have not taken strong medication that affects liver enzymes within the last 14 days.I am 18 years old or older.I don't have any health conditions that would affect my participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Alectinib
- Group 2: Platinum-Based Chemotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers presently recruiting study participants?
"Unfortunately, this specific clinical trial is no longer actively recruiting patients. The trial was initially posted on 8/16/2018 but was last edited on 8/10/2022. If you are interested in other trials, there are 1390 clinical trials for patients with carcinoma, non-small-cell lung and 1518 trials for Alectnib currently looking for patients."
Answered by AI
How many people are approved to participate in this experiment?
"Unfortunately, this study is not currently recruiting patients. The trial began on August 16th, 2018 and concluded on August 10th, 2020. There are other ongoing studies that may be of interest; as of now, there are 1390 trials enrolling patients with non-small-cell lung carcinoma and 1518 trials enrolling patients for Alectinib."
Answered by AI
What are Alectinib's common applications in medicine?
"Alectinib, while most commonly used to treat lymphoma, can also be used as a line of defense against non-hodgkin, recurrent cervical cancer, and locally advanced non-small cell lung cancer."
Answered by AI
Do patients experience many side effects while taking Alectinib?
"Alectinib has received a score of 3 for safety. This is due to the Phase 3 status of the drug, meaning that there is both efficacy data as well as multiple rounds of safety data."
Answered by AI
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