Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib (SAILOR)

Peking University

Status: Enrolling

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

Treatments: Drug: Iruplinalkib tablets

Study type: Observational

Funder types: Other

Identifiers

NCT07374614

2025-324

Details and patient eligibility

About

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.

Full description

Background & Unmet Need:

Lorlatinib, a third-generation ALK tyrosine kinase inhibitor (TKI), is a standard treatment option for patients with advanced ALK-positive lung adenocarcinoma, particularly following the failure of earlier-generation ALK inhibitors. Despite its potent central nervous system penetration and broad coverage of ALK resistance mutations, acquired resistance and disease progression remain inevitable for most patients. Currently, there is no established standard of care for patients who progress on lorlatinib, representing a significant unmet clinical need.

Rationale for Iruplinalkib:

Iruplinalkib is a novel ALK inhibitor exhibiting high selectivity and activity against a broad spectrum of ALK resistance mutations, including those associated with resistance to prior ALK TKIs. While preliminary clinical studies have demonstrated promising antitumor activity and a manageable safety profile in patients with ALK-positive non-small cell lung cancer (NSCLC), data specifically evaluating iruplinalkib in the post-lorlatinib setting are limited, particularly within real-world clinical practice.

Study Objectives:

This study is designed as an observational investigation to assess the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have received prior lorlatinib treatment. The study will include eligible patients who are prescribed iruplinalkib as part of routine clinical practice. This study aims to characterize the clinical benefit of iruplinalkib and explore its potential role as a subsequent-line treatment option in this specific population.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

20 participants in 1 patient group

Treatment group

Treatment:

Drug: Iruplinalkib tablets