Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.
Trial explores genetic links to lung cancer drug effectiveness and side effects.
Plain English Summary
Bioequivalence ANDA SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms is a Phase 3 clinical trial sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair studying Non-small Cell Lung Cancer. This trial tests how specific genetic variations (SNPs) might affect how well alectinib works and its side effects in lung cancer patients. It is for patients diagnosed with Non-Small Cell Lung Cancer (NSCLC) who are suitable for blood draws. Participation involves receiving one of two versions of alectinib (both standard dose) in a randomized, double-blind study, and providing blood samples. Alternatives include standard chemotherapy or other approved treatments for NSCLC outside of this specific trial. The trial aims to enroll 600 participants.
Official 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
Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) who have had a biopsy. Individuals must be able to provide sufficient blood samples and have adequate organ function and overall health. Participants must be 22 years or older and not pregnant or breastfeeding. People who have had a lung removed, are receiving other cancer treatments that cannot be stopped, or have serious allergies or bleeding tendencies cannot join. This trial is studying Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures will identify specific genetic markers that predict whether alectinib will be more effective or cause more side effects for a patient. The specific primary outcome measures are: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (Up to 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to personalize lung cancer treatment by understanding how a patient's genes influence their response to alectinib, potentially leading to more effective and safer therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial investigates a targeted therapy for a common cancer, with the potential to refine treatment strategies and improve patient outcomes, signaling a move towards precision medicine in oncology. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 600 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your specific genetic makeup might influence how you respond to alectinib. Understand that you will be randomly assigned to one of two treatment groups, and neither you nor your doctor will know which one you are receiving (double-blind). Participation requires regular clinic visits for treatment and blood draws. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 600 participants
Interventions
- DRUG: Alectinib - Usual — Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
- DRUG: Alectinib - Study — Study Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Primary Outcomes
- Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (Up to 12 weeks)
Full Eligibility Criteria
* Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing. * 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 after biopsy diagnosis, 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 after biopsy diagnosis, like as the study approach group. Inclusion Criteria: * 1\. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC) * 2\. Clinical biopsy diagnosis of NSCLC * 3\. Suitable for enough blood-drawing * 4\. Random and double blind * 5\. Measurable disease * 6\. Adequate organ functions * 7\. Adequate performance status * 8\. Age 22 years old and over * 9\. Sign an informed consent form * 10\. Receive blood-drawing Exclusion Criteria: * 1\. Pneumonectomy * 2\. Treatment with other anti-cancer therapies and cannot be stopped currently * 3\. Pregnancy * 4\. Breast-feeding * 5\. The patients with other serious intercurrent illness or infectious diseases * 6\. Have more than one different kind of cancer at the same time * 7\. Serious Allergy to Drugs * 8\. Serious Bleed Tendency * 9\. Serious Risks or Serious Adverse Events of the drug product * 10\. The prohibition of drug products * 11\. Have no therapeutic effects * 12\. Follow up to the most current label
Trial Locations
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701, Rockville, Maryland, United States
Frequently Asked Questions
What is clinical trial NCT05987956?
NCT05987956 is a Phase 3 INTERVENTIONAL study titled "Bioequivalence ANDA SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms." It is currently active, not recruiting and is sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. The trial targets enrollment of 600 participants.
What conditions does NCT05987956 study?
This trial investigates treatments for Non-small Cell Lung Cancer. The primary condition under study is Non-small Cell Lung Cancer.
What treatments are being tested in NCT05987956?
The interventions being studied include: Alectinib - Usual (DRUG), Alectinib - Study (DRUG). Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
What does Phase 3 mean for NCT05987956?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT05987956?
This trial is currently "Active, Not Recruiting." It started on 2026-03-18. The estimated completion date is 2026-12-28.
Who is sponsoring NCT05987956?
NCT05987956 is sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05987956?
The trial aims to enroll 600 participants. The trial status is active, not recruiting.
How is NCT05987956 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05987956?
The primary outcome measures are: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. (Up to 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05987956 being conducted?
This trial is being conducted at 1 site, including Rockville, Maryland (United States).
Where can I find official information about NCT05987956?
The official record for NCT05987956 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05987956. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05987956 testing in simple terms?
This trial tests how specific genetic variations (SNPs) might affect how well alectinib works and its side effects in lung cancer patients. It is for patients diagnosed with Non-Small Cell Lung Cancer (NSCLC) who are suitable for blood draws.
Why is this trial significant?
This trial aims to personalize lung cancer treatment by understanding how a patient's genes influence their response to alectinib, potentially leading to more effective and safer therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT05987956?
Potential side effects of alectinib, which can include fatigue, nausea, swelling, and shortness of breath. Risks associated with blood draws, such as bruising or infection. The possibility that the treatment may not be effective for some individuals. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05987956?
Ask your doctor if your specific genetic makeup might influence how you respond to alectinib. Understand that you will be randomly assigned to one of two treatment groups, and neither you nor your doctor will know which one you are receiving (double-blind). Participation requires regular clinic visits for treatment and blood draws. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05987956 signal from an investment perspective?
This trial investigates a targeted therapy for a common cancer, with the potential to refine treatment strategies and improve patient outcomes, signaling a move towards precision medicine in oncology. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving one of two versions of alectinib (both standard dose) in a randomized, double-blind study, and providing blood samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Non-small Cell Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.