An Observational Study of the Efficacy and Safety of Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment

What this Trial Is About

Researchers are evaluating the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have previously been treated with lorlatinib but experienced disease progression or intolerance. This observational study addresses the unmet need for treatment options after lorlatinib, as resistance and disease progression remain common. Iruplinalkib, a novel ALK inhibitor, shows promise against various ALK resistance mutations and is being studied for its potential role in this patient population. Eligible patients who have started iruplinalkib treatment as part of routine clinical care will be included. Iruplinalkib is administered as 180 mg tablets taken once daily. The study will collect real-world data on its use without altering patients' usual treatment plans. This investigation does not involve randomization or placebo control but observes patients receiving the drug in clinical practice. Participants will be followed for an average of 36 months from the index date to monitor real-world progression-free survival. Additional assessments include time to next treatment, overall survival, and treatment-related adverse reactions. Data collected will include baseline characteristics, treatment history, and follow-up outcomes from medical records to evaluate the clinical benefit and safety of iruplinalkib in this heavily pretreated group.

Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib