NCT07374614 Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
| NCT ID | NCT07374614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Shenzhen Hospital |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-31 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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Brief 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 Criteria
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
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