Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Shenzhen Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Iruplinalkib tablets
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Peking University Shenzhen Hospital
Lead sponsor
Shenzhen People's Hospital
Collaborator
Longgang District People's Hospital of Shenzhen
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
People Hospital of New District Longhua Shenzhen
Collaborator
Source ClinicalTrials.gov