Mechanism study of osimertinib-induced long QT syndrome: roles of PRMT1 and CIRP phase separation

Mechanism Study of Osimertinib Promoting CIRP Phase Separation via PRMT1 to Induce Long QT Syndrome

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600127274

Enrollment

Unknown

Registered

2026-06-29

Start date

2026-06-30

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

Osimertinib Treatment Group:None

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with non-small cell lung cancer (NSCLC) confirmed by pathology or cytology who have received osimertinib treatment for >=15 days; 2.Age >= 18 years; 3.ECOG performance status score of 0–2; 4.Expected survival >= 3 months; 5.Complete clinical and pathological data, with regular clinical follow-ups; 6.Good treatment compliance and no severe diseases of other vital organs;

Exclusion criteria

Exclusion criteria: 1.Baseline prolonged QTc interval or history of long QT syndrome (LQTS); 2.Known severe arrhythmia, heart failure, or recent myocardial infarction prior to enrollment; 3.Concurrent use of other medications known to prolong the QTc interval that cannot be discontinued or substituted; 4.Presence of uncorrected severe electrolyte disturbances (e.g., hypokalemia, hypomagnesemia, hypocalcemia); 5.Concomitant use of strong CYP3A4 inhibitors or inducers; 6.Pregnant or breastfeeding women;

Design outcomes

Primary

Measure	Time frame
Serum PRMT1 concentrations;Serum CIRP concentrations;	—

Secondary

Measure	Time frame
The degree of QTc interval extension;The correlation of the incidence of QT interval prolongation events;Demographic characteristics: age, gender, BMI, smoking history;Tumor-related information: Tumor pathological type, EGFR mutation type, TNM stage, number of osimertinib treatment lines (first line/second line and above), history of previous anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy, etc.), history of previous use of cardiotoxic drugs;Laboratory test indicators: blood potassium, blood magnesium, blood calcium, liver and kidney function, albumin;Combined medication situation: especially other drugs that prolong the QT interval and CYP3A4 modulators;	—

Measure

Time frame

The degree of QTc interval extension;The correlation of the incidence of QT interval prolongation events;Demographic characteristics: age, gender, BMI, smoking history;Tumor-related information: Tumor pathological type, EGFR mutation type, TNM stage, number of osimertinib treatment lines (first line/second line and above), history of previous anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy, etc.), history of previous use of cardiotoxic drugs;Laboratory test indicators: blood potassium, blood magnesium, blood calcium, liver and kidney function, albumin;Combined medication situation: especially other drugs that prolong the QT interval and CYP3A4 modulators;

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Countries

China

Contacts

Public ContactLi Yuexin

Harbin Medical University Cancer Hospital

liyuexin95@hrbmu.edu.cn+86 451 86298399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026