Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib

Recruiting now

Conditions studied: Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Lorlatinib, Real-world Study, Observational Study

In brief

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.

Key facts

Study ID

NCT07374614

Run by

Peking University Shenzhen Hospital

People needed

20

Starts

2026-01-31

Expected to finish

2028-12-31

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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