Iruplinalkib for ALK-positive advanced lung adenocarcinoma after lorlatinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, real-world study will collect clinical outcomes from adults with advanced ALK-positive lung adenocarcinoma who started iruplinalkib after progressing on or being intolerant to lorlatinib. Patients treated as part of routine care at participating centers will have baseline characteristics, prior treatment history, tumor measurements, and safety events recorded and followed over time without experimental interventions. The study requires documented ALK rearrangement and at least one evaluable lesion and does not randomize treatment. Data will be analyzed to describe response patterns, duration of benefit, and treatment-related adverse events in this heavily pretreated population.

Why it matters

Who can join: the full rules

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 basal cell carcinoma, etc.).
3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.
4. Pregnancy: Pregnant or breastfeeding women.
5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Fen Wang
• Email: fina_wang@163.com
• Phone: +86 13510331485

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.