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RecruitingNCT07374614

Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib

An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment

Sponsor

Peking University Shenzhen Hospital

Enrollment

20 participants

Start Date

Jan 31, 2026

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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).

Interventions

DRUGIruplinalkib tablets

180mg, QD

Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07374614