Alectinib / ALK Positive Non Small Cell Lung Cancer (NSCLC) · Phase 2/3 Trial

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2/3 interventional study registered to explore associations between ALK and CYP450 3A4 single nucleotide polymorphisms and alectinib therapeutic efficacy and adverse effects in patients with ALK-positive non-small cell lung cancer. No results are posted in this registry record; the study is active but not currently recruiting.

What was studied

Phase 2/3, Interventional, Sequential, Open label, Health Services Research purpose. ALK-Positive Non-Small Cell Lung Cancer (NSCLC); age from 24 Years; to 64 Years. Intervention: Alectinib. n = 600. 2 sites: United States.

Key findings

Safety

Primary outcomes are genotyping measures, not clinical efficacy or toxicity events

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2/3 registry record with no reported results; it describes a planned pharmacogenomics study exploring SNP associations with alectinib efficacy and toxicity in ALK-positive NSCLC, currently active but not recruiting.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated (assessed at Up to 12 weeks); Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated (assessed at Up to 12 weeks)

DesignPhase 2/3, Interventional, Sequential, Open label, Health Services Research purpose

PopulationALK-Positive Non-Small Cell Lung Cancer (NSCLC); age from 24 Years; to 64 Years

Sample size600

InterventionAlectinib

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size600

PhasePhase 2/Phase 3

Primary outcome measure 1Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, up to 12 weeks

Primary outcome measure 2Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated, up to 12 weeks

Caveats

This is a registry record only; no results are reported
Study design details (randomization, blinding, control group) not specified in this record
Primary outcomes are genotyping measures, not clinical efficacy or toxicity events
Analysis plan and statistical methods not disclosed in registry record

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2/3 interventional pharmacogenomics study with planned enrollment of 600 participants

Directness

strong

Directly examines ALK and CYP450 3A4 SNP associations with alectinib efficacy and toxicity

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed

Risk of bias

insufficient

No methods, blinding strategy, or analytical details reported in registry record

Sample adequacy

moderate

Estimated enrollment 600 participants; adequate for pharmacogenomics association study

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05987956). This is a study registration, not published results. Lead sponsor: Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: ALK-Positive Non-Small Cell Lung Cancer (NSCLC). Interventions: DRUG: Alectinib. Primary outcome measures: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated , Up to 12 weeks; Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated , Up to 12 weeks. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

AlectinibHan Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairALK Positive Non Small Cell Lung Cancer (NSCLC)NCT05987956