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NCT07374614Recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
20 (estimated)
First submitted
16 Jan 2026
Start date
31 Jan 2026
Primary completion date
31 Dec 2028
Lead sponsor
Peking University Shenzhen Hospital
Diseases
Lung cancer
NCT number
NCT07374614

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 31 Jan 2026 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.
  • Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).

Other illness

  • Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).

Other

  • Pregnancy: Pregnant or breastfeeding women.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Shenzhen Hospital
Coordinator of this site? Confirm its status
ShenzhenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.