Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib

Real-World Progression-Free Survival (rwPFS)

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.

Time to Next Treatment (TTNT)

TTNT is defined as the time interval from the index date (date of first dose of the study treatment) to the date of the first administration of a new (subsequent) systemic anti-cancer therapy. This outcome distinguishes the duration of the current line of therapy before a switch is made. Patients who die without receiving a subsequent therapy are censored at the date of death. Patients who remain on the study treatment or discontinue treatment without starting a new line are censored at their last known activity date or the data cutoff date.

Overall survival (OS)

To assess overall survival, define as first dose to the death of the subject due to any cause

Treatment-related adverse reactions ( TRAE )

All AEs will be evaluated by the investigators to determine their potential relationship to iruplinalkib treatment based on clinical judgment, temporal association, and alternative etiologies. Events assessed as possibly, probably, or definitely related to iruplinalkib will be classified as treatment-related adverse reactions (TRAEs). The TRAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, 5.0). Serious adverse events (SAEs) will be identified and recorded in accordance with standard definitions or are considered medically significant by the investigator.

Real-World Objective Response Rate (rwORR)

rwORR is defined as the proportion of patients with a best overall response (BOR) of real-world complete response (rwCR) or real-world partial response (rwPR) as documented in the electronic health records (EHR). Response assessment is based on the treating clinician's qualitative assessment in clinical notes (clinician-anchored) and/or radiology reports, without strictly requiring RECIST 1.1 measurements. Patients without sufficient data to assess response are considered non-responders.

Real-World Disease Control Rate (rwDCR)

rwDCR is defined as the proportion of patients with a best overall response (BOR) of real-world complete response (rwCR), real-world partial response (rwPR), or real-world stable disease (rwSD). To be classified as rwSD, the condition must be maintained for a minimum duration (e.g., at least 6 weeks) from the index date. Assessment is derived from unstructured clinical notes (clinician-anchored).