Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms (NCT05987956) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
United States600 participantsStarted 2026-03-18
Plain-language summary
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Who can participate
Age range
24 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
* Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
* Had no further NSCLC metastatic or growth in more than previous 90 days
* Dosage Duration at least 90 days
* The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
* The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
Inclusion Criteria:
* 1\. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
* Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
* Had no further NSCLC metastatic or growth in more than previous 90 days
* 2\. Suitable for enough blood-drawing
* 3\. Random and double blind
* 4\. Measurable disease
* 5\. Adequate organ functions
* 6\. Adequate performance status
* 7\. Age 24-64 years old
* 8\. Sign an informed consent form
* 9\. Receive blood-drawing
Exclusion Criteria:
* 1\. Pneumonectomy
* 2\. Treatment with other anti-cancer therapies …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Timeframe: Up to 12 weeks
2
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated