Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
Recruiting · NCT07374614 · Observational (researchers observe without assigning treatment) · Lead sponsor: Peking University Shenzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Iruplinalkib tablets
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Population: Male or female patients aged ≥18 years.
- Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.
- Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).
- Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.
- Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.
- Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.
- Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).
Exclusion criteria
- 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.
- Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).
- Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.
- Pregnancy: Pregnant or breastfeeding women.
- Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).
Where it is running
1 location listed.
- Peking University Shenzhen Hospital - Shenzhen, Guangdong, China