Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib

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

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).

Conditions8

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