An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment
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.
• Population: Male or female patients aged ≥18 years.
• Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.
• Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).
• Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.
• Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.
• Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.
• Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).