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Clinical Trials in China / NCT07374614
Recruiting Observational

Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib

NCT07374614 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Shenzhen Hospital
Phase
Observational
Started
2026-01-31
Last updated
2026-01-29

Condition(s) studied

Non-Small Cell Lung CancerALKIruplinalkibLorlatinibReal-world StudyObservational Study

Investigational drug(s) / intervention(s)

Iruplinalkib tablets

Iruplinalkib tablets: 180mg, QD

Study summary

This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Population: Male or female patients aged ≥18 years. 2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma. 3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH). 4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance. 5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting. 6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment. 7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes). Exclusion Criteria: 1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \< 1 week/cycle) before withdrawal for non-medical reasons. 2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.). 3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently. 4. Pregnancy: Pregnant or breastfeeding women. 5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07374614 on ClinicalTrials.gov ↗ ← All trials in China