Alectinib Pharmacogenomics for Lung Cancer
(Drugs-SNPs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates how genetic differences in patients with non-small cell lung cancer affect their response to ALECENSA treatment. By studying these genetic variations, researchers aim to improve the effectiveness and safety of the medication.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who cannot stop other anti-cancer therapies. It seems you may need to stop such treatments to participate.
Is Alectinib safe for humans?
Alectinib has been studied for safety in patients with a specific type of lung cancer (ALK-positive non-small-cell lung cancer) and is generally considered safe, but some patients may stop treatment due to recurrence or side effects. It has received special designations from the FDA, indicating its potential benefits and safety profile.12345
How is the drug Alectinib unique for treating lung cancer?
Alectinib is unique because it is a second-generation, orally active drug specifically designed to target and inhibit the anaplastic lymphoma kinase (ALK) in non-small cell lung cancer (NSCLC) patients who have developed resistance to the first-generation ALK inhibitor, crizotinib. It is highly effective in treating ALK-positive NSCLC, including cases with brain metastases, and has received special designations like orphan drug and breakthrough therapy due to its promising results.12467
What data supports the effectiveness of the drug Alectinib for lung cancer?
Alectinib has shown promising results in treating patients with ALK-positive non-small cell lung cancer (NSCLC), especially those who have developed resistance to the first-line drug crizotinib. In clinical trials, alectinib achieved a high response rate, with many patients experiencing rapid and sustained tumor shrinkage, and it was generally well tolerated.12467
Who Is on the Research Team?
Han Xu, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. - IORG0007849
Han Xu, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. - IORG0007849
Han Xu, MD/PhD/FAPCR
Principal Investigator
Medicine Invention Design, Inc. - IORG0007849
Are You a Good Fit for This Trial?
Adults over 22 with non-small cell lung cancer (NSCLC) who can undergo a lung tissue biopsy and have not used other anti-cancer therapies. They must be in good health otherwise, able to sign consent, and not pregnant or breastfeeding. Those with serious allergies, bleeding tendencies, multiple cancers, or severe illnesses cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Alectinib 600 mg orally twice daily and undergo genotyping for ALK and CYP4503A4 SNPs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alectinib
Alectinib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Lead Sponsor
UnitedHealthcare
Collaborator