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)
Real-World Progression-Free Survival (rwPFS) — From index date through study completion, an average of 36 months Time from treatment initiation to the earliest of death or clinical disease progression. Progression is defined by the treating provider's assessment recorded in the medical record, based on radiology, laboratory, or physical exam findings, distinct from RECIST-based radiographic progression.
Trial sites (1)
Facility
City
Region
Status
Peking University Shenzhen Hospital
Shenzhen
Guangdong
Recruiting
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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.
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