Iruplinalkib for 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
We will try iruplinalkib in adults with advanced ALK-positive lung adenocarcinoma who progressed on or couldn't tolerate lorlatinib to see how well it works and how safe it is in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Shenzhen Hospital Academic / other |
| Drugs / interventions | lorlatinib |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07374614 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed advanced ALK-positive lung adenocarcinoma who progressed on or were intolerant to lorlatinib, initiated iruplinalkib in routine care, and have available baseline and follow-up clinical data are the intended participants.
Not a fit: Patients without confirmed ALK rearrangement, with other active non-ALK primary malignancies, or who never actually received iruplinalkib (or took it only briefly) are unlikely to derive benefit from this observational dataset.
Why it matters
Potential benefit: If successful, iruplinalkib could offer an effective treatment option for patients who progress on lorlatinib by targeting a broad range of ALK resistance mutations.
How similar studies have performed: Early clinical trials of iruplinalkib have shown promising antitumor activity and a manageable safety profile in ALK-positive NSCLC, but evidence specifically in the post-lorlatinib setting remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shenzhen, Guangdong
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fen Wang
- Email: fina_wang@163.com
- Phone: +86 13510331485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.