What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly ALK inhibitors like Alectinib and crizotinib, often cause gastrointestinal issues (nausea, diarrhea, constipation), liver enzyme abnormalities, fatigue, edema, and muscle pain. Immune checkpoint inhibitors such as pembrolizumab, used in combination with chemotherapy, can lead to immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy is also associated with myelosuppression, neuropathy, and alopecia.

What prior FDA approvals exist?

Several ALK inhibitors have received FDA approval for the treatment of ALK-rearranged Non-Small Cell Lung Cancer (NSCLC), including Alectinib, Crizotinib, Ceritinib, Brigatinib, and Lorlatinib. These targeted therapies specifically address genetic mutations in the ALK gene. Additionally, immune checkpoint inhibitors such as Pembrolizumab and Nivolumab, which target PD-1/PD-L1 pathways, are also approved for NSCLC treatment. Chemotherapy regimens involving drugs like carboplatin and paclitaxel are commonly used as well.

What other types of research exist?

Promising novel alternatives to Alectinib for ALK-positive NSCLC patients include Lorlatinib, which has shown efficacy in patients with resistance to prior ALK inhibitors, and Ensartinib, which has demonstrated superior progression-free survival compared to Crizotinib in clinical trials. Additionally, Brigatinib is another option that has been effective in patients who have progressed on Alectinib.

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Targeted Therapy

Alectinib Pharmacogenomics for Lung Cancer (Drugs-SNPs Trial)

Phase 2 & 3

Waitlist Available

Led By Han Xu, M.D., Ph.D.

Research Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The study is looking at how genetic differences affect the way Alectinib works for NSCLC treatment. It involves precise gene sequencing to understand this relationship better and will compare usual Alectinib use against a study-specific approach.

What are the potential side effects?

Alectinib may cause side effects like liver issues, kidney problems, slow heartbeat, muscle pain or weakness; however specific side effects related to genetic variations are being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Alectinib - UsualExperimental Treatment1 Intervention

* Usual ALECENSA - Alectinib * Chemotherapy (NDC...01) * Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Usual Approach Group (NDC...01) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Group II: Alectinib - StudyExperimental Treatment1 Intervention

* Study ALECENSA - Alectinib * Chemotherapy (NDC...86) * Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Study Approach Group (NDC...86) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. ALK inhibitors, such as Alectinib, work by blocking the activity of the anaplastic lymphoma kinase (ALK) fusion oncogene, which drives cancer cell proliferation in a subset of NSCLC patients. Similarly, EGFR inhibitors (e.g., osimertinib, erlotinib) target mutations in the epidermal growth factor receptor (EGFR) to inhibit tumor growth. Immunotherapies, like anti-PD-1/PD-L1 antibodies, enhance the immune system's ability to recognize and destroy cancer cells. These treatments are crucial for NSCLC patients as they offer more personalized and effective options, often leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Rapid and dramatic response to alectinib in an anaplastic lymphoma kinase rearranged non-small-cell lung cancer patient who is critically ill.Effect of ALK-inhibitors in the treatment of non-small cell lung cancer: a systematic review and meta-analysis.