Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
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 fo
| Condition(s) | Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Lorlatinib, Real-world Study, Observational Study |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 rece |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Peking University Shenzhen Hospital |
| Locations | Shenzhen, Guangdong, China |
| Start date | 2026-01-31 |
| NCT ID | NCT07374614 |
| Official listing | https://clinicaltrials.gov/study/NCT07374614 |